{"protocolSection":{"identificationModule":{"nctId":"NCT01541215","orgStudyIdInfo":{"id":"NN2211-3659"},"secondaryIdInfos":[{"id":"2011-002605-29","type":"EUDRACT_NUMBER"},{"id":"P/288/2010","type":"OTHER","domain":"EMA (PDCO)"},{"id":"U1111-1121-8743","type":"OTHER","domain":"WHO"},{"id":"CTRI/2013/10/004082","type":"REGISTRY","domain":"Clinical Trials Registry - India (CTRI)"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes","officialTitle":"Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes","acronym":"Ellipse™"},"statusModule":{"statusVerifiedDate":"2021-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-11-13","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2017-11-15","type":"ACTUAL"},"completionDateStruct":{"date":"2020-05-20","type":"ACTUAL"},"studyFirstSubmitDate":"2012-02-23","studyFirstSubmitQcDate":"2012-02-28","studyFirstPostDateStruct":{"date":"2012-02-29","type":"ESTIMATED"},"resultsFirstSubmitDate":"2018-11-15","resultsFirstSubmitQcDate":"2018-11-15","resultsFirstPostDateStruct":{"date":"2018-12-11","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-07-01","lastUpdatePostDateStruct":{"date":"2021-07-02","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":135,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Lira + Met","type":"EXPERIMENTAL","interventionNames":["Drug: liraglutide","Drug: metformin"]},{"label":"Placebo + Met","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo","Drug: metformin"]}],"interventions":[{"type":"DRUG","name":"liraglutide","description":"Administered subcutaneously (s.c., under the skin) once daily.1.8 mg or maximum tolerated dose (MTD: 0.6 mg, 1.2 mg, 1.8 mg) for 26 weeks. Subjects will continue treatment in a 26 week open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.","armGroupLabels":["Lira + Met"]},{"type":"DRUG","name":"placebo","description":"Administered subcutaneously (s.c., under the skin) once daily for 26 weeks. Subjects will discontinue placebo treatment in the open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.","armGroupLabels":["Placebo + Met"]},{"type":"DRUG","name":"metformin","description":"Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.","armGroupLabels":["Lira + Met","Placebo + Met"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in HbA1c (Glycosylated Haemoglobin)","description":"Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG)","description":"Change in FPG from baseline to week 26. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Number of Subjects Having HbA1c Below 7.0%","description":"Percentage of subjects having HbA1c \\<7.0%. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 26"},{"measure":"Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)","description":"Change in BMI SDS from baseline to week 26. BMI SDS was calculated using the following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Number of Subjects Having HbA1c Below 7.0%","description":"Number of subjects achieving HbA1c \\<7.0% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 52"},{"measure":"Number of Subjects Having HbA1c Maximum 6.5%","description":"Number of subjects achieving HbA1c \\<=6.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 26"},{"measure":"Number of Subjects Having HbA1c Maximum 6.5%","description":"Number of subjects achieving HbA1c \\<=6.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 52"},{"measure":"Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes","description":"Number of subjects achieving HbA1c \\<7.0% without severe or minor hypoglycaemic episodes after 26 weeks.\n\nSevere hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.\n\nMinor hypoglycaemia was defined as meeting either of the below criteria:\n\n1. an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \\<2.8 mmol/L (50 mg/dL) or plasma glucose \\<3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself\n2. any asymptomatic blood glucose value \\<2.8 mmol/L (50 mg/dL) or plasma glucose value \\<3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 26"},{"measure":"Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes","description":"Number of subjects achieving HbA1c \\<7.0% without severe or minor hypoglycaemic episodes after 52 weeks.\n\nSevere hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.\n\nMinor hypoglycaemia was defined as meeting either of the below criteria:\n\n1. an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \\<2.8 mmol/L (50 mg/dL) or plasma glucose \\<3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself\n2. any asymptomatic blood glucose value \\<2.8 mmol/L (50 mg/dL) or plasma glucose value \\<3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 52"},{"measure":"Number of Subjects Having HbA1c Below 7.5%","description":"Number of subjects achieving HbA1c \\<7.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 26"},{"measure":"Number of Subjects Having HbA1c Below 7.5%","description":"Number of subjects achieving HbA1c \\<7.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 52"},{"measure":"Change in HbA1c","description":"Change in HbA1c from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Change in FPG","description":"Change in FPG from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Change in Mean 7-point Self-measured Plasma Glucose","description":"Change in mean 7-point self-measured plasma glucose after 26 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Change From Baseline in 7-point Self-measured Plasma Glucose","description":"Change in mean 7-point self-measured plasma glucose after 52 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)","description":"Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)","description":"Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)","description":"Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)","description":"Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Change From Baseline in Body Weight","description":"Change from baseline in body weight after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Change From Baseline in Body Weight","description":"Change from baseline in body weight after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Change From Baseline in BMI Standard Deviation Score (SDS)","description":"Change in BMI SDS from baseline to week 52. BMI SDS was calculated using the following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Change in Blood Pressure (Systolic and Diastolic Blood Pressure)","description":"Change in blood pressure (systolic and diastolic blood pressure) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Change in Blood Pressure (Systolic and Diastolic Blood Pressure)","description":"Change in blood pressure (systolic and diastolic blood pressure) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Ratio to Baseline: Fasting Insulin","description":"Ratio to baseline (fasting insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Ratio to Baseline: Fasting Insulin","description":"Ratio to baseline (fasting insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Ratio to Baseline: Fasting Pro-insulin","description":"Ratio to baseline (fasting pro-insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Ratio to Baseline: Fasting Pro-insulin","description":"Ratio to baseline (fasting pro-insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Ratio to Baseline: Pro-insulin/Insulin Ratio","description":"Ratio to baseline (Pro-insulin/insulin ratio) after week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Ratio to Baseline: Pro-insulin/Insulin Ratio","description":"Ratio to baseline (Pro-insulin/insulin ratio) after week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Ratio to Baseline: Fasting Glucagon","description":"Ratio to baseline (fasting glucagon) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Ratio to Baseline: Fasting Glucagon","description":"Ratio to baseline (fasting glucagon) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Ratio to Baseline: Fasting C-peptide","description":"Ratio to baseline (fasting C-peptide) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Ratio to Baseline: Fasting C-peptide","description":"Ratio to baseline (fasting C-peptide) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)","description":"Ratio to baseline (HOMA-B) after 26 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Ratio to Baseline: HOMA-B","description":"Ratio to baseline (HOMA-B) after 52 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)","description":"Ratio to baseline (HOMA-IR) after 26 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Ratio to Baseline: HOMA-IR","description":"Ratio to baseline (HOMA-IR) after 52 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Ratio to Baseline: Total Cholesterol","description":"Ratio to baseline (total cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Ratio to Baseline: Total Cholesterol","description":"Ratio to baseline (total cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol","description":"Ratio to baseline (LDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Ratio to Baseline: LDL Cholesterol","description":"Ratio to baseline (LDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol","description":"Ratio to baseline (VLDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Ratio to Baseline: VLDL Cholesterol","description":"Ratio to baseline (VLDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol","description":"Ratio to baseline (HDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Ratio to Baseline: HDL Cholesterol","description":"Ratio to baseline (HDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Ratio to Baseline: Triglycerides","description":"Ratio to baseline (triglycerides) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Ratio to Baseline: Triglycerides","description":"Ratio to baseline (triglycerides) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Ratio to Baseline: Free Fatty Acids","description":"Ratio to baseline (free fatty acids) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Ratio to Baseline: Free Fatty Acids","description":"Ratio to baseline (free fatty acids) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Change From Baseline in Pulse","description":"Change from baseline in pulse 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Change From Baseline in Pulse","description":"Change from baseline in pulse 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Change From Baseline in Height SDS","description":"Change in height SDS from baseline to week 26. Height SDS was calculated using the following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Change From Baseline in Height SDS","description":"Change in height SDS from baseline to week 52. Height SDS was calculated using the following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Change in Bone Age Assessment (X-ray of Left Hand and Wrist)","description":"Change in bone age from baseline to week 52. If the baseline (week 0) bone age assessment indicated that all epiphyses were fused, then the assessment was not repeated at week 52.","timeFrame":"Week 0, week 52"},{"measure":"Pubertal Assessment/Progression (Tanner Staging)","description":"Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of participants at different Tanner stages at week 0, week 26 and week 52.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Growth (Height Velocity)","description":"Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.","timeFrame":"Week 0, week 26"},{"measure":"Growth (Height Velocity)","description":"Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.","timeFrame":"Week 0, week 52"},{"measure":"Height Velocity SDS","description":"Height velocity SDS scores at week 26. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Height Velocity SDS","description":"Height velocity SDS scores at week 52. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Number of Hypoglycaemic Episodes","description":"Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 26.","timeFrame":"0-26 weeks"},{"measure":"Number of Hypoglycaemic Episodes","description":"Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 52.","timeFrame":"0-52 weeks"},{"measure":"Number of Adverse Events (Week 0-26)","description":"Total number of adverse events during 26 weeks.","timeFrame":"0-26 weeks"},{"measure":"Number of Adverse Events (Week 0-52)","description":"Total number of adverse events during entire treatment period.","timeFrame":"0-52 weeks"},{"measure":"Number of Serious Adverse Events (Week 0-26)","description":"Total number of serious adverse events during 26 weeks.","timeFrame":"0-26 weeks"},{"measure":"Number of Serious Adverse Events (Week 0-52)","description":"Total number of serious adverse events during entire treatment period.","timeFrame":"0-52 weeks"},{"measure":"Number of Adverse Events (Week 53-104)","description":"This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during follow-up 1 (week 53 to 104).","timeFrame":"Week 53-104"},{"measure":"Number of Serious Adverse Events (Week 53-104)","description":"This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during follow up 1 (week 53 to 104).","timeFrame":"Weeks 53-104"},{"measure":"Growth (Height Velocity)- Week 104","description":"Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.","timeFrame":"Week 0, week 104"},{"measure":"Height Velocity SDS- Week 104","description":"The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.","timeFrame":"Week 0, week 104"},{"measure":"Change From Week 52 in Height SDS- Week 104","description":"Change in height SDS from week 52 to week 104. Height SDS was calculated using the following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.","timeFrame":"Week 52, week 104"},{"measure":"Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104","description":"Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents \"pre-adoloscent development\" and stage V represents \"pubertal development equivalent to that of an adult\". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.","timeFrame":"Week 52, week 104"},{"measure":"Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104","description":"Change in bone age from week 52 to week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.","timeFrame":"Week 52, week 104"},{"measure":"Number of Adverse Events (Week 53-156)","description":"This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during the follow-up period (weeks 53 to 156).","timeFrame":"Week 53-156"},{"measure":"Number of Serious Adverse Events (Week 53-156)","description":"This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during the follow up period (week 53 to 156).","timeFrame":"Weeks 53-156"},{"measure":"Growth (Height Velocity)- Week 156","description":"Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.","timeFrame":"Week 0, week 156"},{"measure":"Height Velocity SDS- Week 156","description":"The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.","timeFrame":"Week 0, week 156"},{"measure":"Change From Week 52 in Height SDS- Week 156","description":"Change in height SDS from week 52 to week 156. Height SDS was calculated using the following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.","timeFrame":"Week 52, week 156"},{"measure":"Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156","description":"Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents \"pre-adoloscent development\" and stage V represents \"pubertal development equivalent to that of an adult\". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.","timeFrame":"Week 52, week 156"},{"measure":"Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156","description":"Change in bone age from week 52 to week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.","timeFrame":"Week 52, week 156"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria: - Children and adolescents between the ages of 10-16 years. 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Liraglutide in Children and Adolescents with Type 2 Diabetes. N Engl J Med. 2019 Aug 15;381(7):637-646. doi: 10.1056/NEJMoa1903822. Epub 2019 Apr 28."},{"pmid":"33634589","type":"DERIVED","citation":"Bensignor MO, Bomberg EM, Bramante CT, Divyalasya TVS, Hale PM, Ramesh CK, Rudser KD, Kelly AS. Effect of liraglutide treatment on body mass index and weight parameters in children and adolescents with type 2 diabetes: Post hoc analysis of the ellipse trial. Pediatr Obes. 2021 Aug;16(8):e12778. doi: 10.1111/ijpo.12778. Epub 2021 Feb 25."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com/sharing-results"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Eligible subjects entered an 11- to 12-week run-in period where they were to undergo a 3-4 week titration of metformin to a maximum tolerated dose of metformin (≥1000 mg and ≤2000 mg per day) followed by an 8-week maintenance period.","recruitmentDetails":"The trial was conducted at 84 sites in 25 countries.","groups":[{"id":"FG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"FG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"periods":[{"title":"Treatment Period (52 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"66"},{"groupId":"FG001","numSubjects":"69"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"66"},{"groupId":"FG001","numSubjects":"68"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"56"},{"groupId":"FG001","numSubjects":"53"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"16"}]}],"dropWithdraws":[{"type":"Withdrawal criteria","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"8"}]},{"type":"Non-compliance","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}]}]},{"title":"Follow up 1 (Weeks 53-104)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"Subjects who attended safety follow up visit at week 104 were included.","numSubjects":"52"},{"groupId":"FG001","comment":"Follow up was not planned for the subjects who received placebo.","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Follow up 2 (Weeks 105-156)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"Subjects who attended safety follow up visit at week 156 were included.","numSubjects":"48"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) - included all randomised subjects receiving at least one dose of liraglutide/placebo","groups":[{"id":"BG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"BG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"66"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"134"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"14.57","spread":"1.73"},{"groupId":"BG001","value":"14.57","spread":"1.73"},{"groupId":"BG002","value":"14.57","spread":"1.72"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"41"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"83"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"51"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"39"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"95"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"18"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"16"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"87"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"10"}]}]}]},{"title":"Glycosylated hemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7.87","spread":"1.35"},{"groupId":"BG001","value":"7.69","spread":"1.34"},{"groupId":"BG002","value":"7.78","spread":"1.34"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in HbA1c (Glycosylated Haemoglobin)","description":"Change in HbA1c from baseline to week 26. 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Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.643","spread":"0.215"},{"groupId":"OG001","value":"0.415","spread":"0.216"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for week 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. 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Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"63.7"},{"groupId":"OG001","value":"36.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Missing data was imputed using pattern mixture model. For each imputed data set the binary response was analysed in a logistic regression model using a logit link with treatment and stratification group (gender\\*age group) as fixed factors and baseline HbA1c as covariate.The estimated treatment effects and confidence intervals were combined using Rubin´s formula.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:\n\nStep 3: HbA1c \\< 7.0% after 26 weeks of treatment","pValue":"<0.001","statisticalMethod":"logistic regression model","paramType":"Treatment odds ratio","paramValue":"5.353","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.105","ciUpperLimit":"13.615"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)","description":"Change in BMI SDS from baseline to week 26. BMI SDS was calculated using the following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"SDS score","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.254","spread":"0.039"},{"groupId":"OG001","value":"-0.208","spread":"0.039"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:\n\nStep 4: Change from baseline in BMI SDS after 26 weeks of treatment","pValue":"0.392","statisticalMethod":"Pattern Mixture Model","paramType":"Treatment difference","paramValue":"-0.047","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.153","ciUpperLimit":"0.060","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.055"}]},{"type":"SECONDARY","title":"Number of Subjects Having HbA1c Below 7.0%","description":"Number of subjects achieving HbA1c \\<7.0% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"52"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"16"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"36"}]}]}]},{"type":"SECONDARY","title":"Number of Subjects Having HbA1c Maximum 6.5%","description":"Number of subjects achieving HbA1c \\<=6.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"58"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"19"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"39"}]}]}]},{"type":"SECONDARY","title":"Number of Subjects Having HbA1c Maximum 6.5%","description":"Number of subjects achieving HbA1c \\<=6.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"52"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"13"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"39"}]}]}]},{"type":"SECONDARY","title":"Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes","description":"Number of subjects achieving HbA1c \\<7.0% without severe or minor hypoglycaemic episodes after 26 weeks.\n\nSevere hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.\n\nMinor hypoglycaemia was defined as meeting either of the below criteria:\n\n1. an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \\<2.8 mmol/L (50 mg/dL) or plasma glucose \\<3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself\n2. any asymptomatic blood glucose value \\<2.8 mmol/L (50 mg/dL) or plasma glucose value \\<3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"58"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"21"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"37"}]}]}]},{"type":"SECONDARY","title":"Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes","description":"Number of subjects achieving HbA1c \\<7.0% without severe or minor hypoglycaemic episodes after 52 weeks.\n\nSevere hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.\n\nMinor hypoglycaemia was defined as meeting either of the below criteria:\n\n1. an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \\<2.8 mmol/L (50 mg/dL) or plasma glucose \\<3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself\n2. any asymptomatic blood glucose value \\<2.8 mmol/L (50 mg/dL) or plasma glucose value \\<3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"52"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"16"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"36"}]}]}]},{"type":"SECONDARY","title":"Number of Subjects Having HbA1c Below 7.5%","description":"Number of subjects achieving HbA1c \\<7.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"58"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"29"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"29"}]}]}]},{"type":"SECONDARY","title":"Number of Subjects Having HbA1c Below 7.5%","description":"Number of subjects achieving HbA1c \\<7.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"52"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"23"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"29"}]}]}]},{"type":"SECONDARY","title":"Change in HbA1c","description":"Change in HbA1c from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of HbA1c","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"52"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.732","spread":"1.423"},{"groupId":"OG001","value":"0.677","spread":"1.523"}]}]}]},{"type":"SECONDARY","title":"Change in FPG","description":"Change in FPG from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.627","spread":"2.717"},{"groupId":"OG001","value":"0.983","spread":"3.954"}]}]}]},{"type":"SECONDARY","title":"Change in Mean 7-point Self-measured Plasma Glucose","description":"Change in mean 7-point self-measured plasma glucose after 26 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"46"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.384","spread":"2.638"},{"groupId":"OG001","value":"0.198","spread":"2.056"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in 7-point Self-measured Plasma Glucose","description":"Change in mean 7-point self-measured plasma glucose after 52 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.309","spread":"2.968"},{"groupId":"OG001","value":"-0.748","spread":"1.944"}]}]}]},{"type":"SECONDARY","title":"Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)","description":"Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of analysed=participants with available data for specified timepoints.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"46"}]}],"classes":[{"title":"Breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"46"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.528","spread":"3.168"},{"groupId":"OG001","value":"-0.319","spread":"3.228"}]}]},{"title":"Lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"43"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.358","spread":"3.281"},{"groupId":"OG001","value":"-0.658","spread":"3.421"}]}]},{"title":"Dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"42"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.397","spread":"3.790"},{"groupId":"OG001","value":"-0.226","spread":"2.806"}]}]}]},{"type":"SECONDARY","title":"Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)","description":"Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of analysed=participants with available data for specified timepoints.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"38"}]}],"classes":[{"title":"Breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"38"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.802","spread":"3.338"},{"groupId":"OG001","value":"0.053","spread":"2.124"}]}]},{"title":"Lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"36"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.735","spread":"3.809"},{"groupId":"OG001","value":"-1.219","spread":"3.038"}]}]},{"title":"Dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"36"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.028","spread":"3.501"},{"groupId":"OG001","value":"-0.195","spread":"2.803"}]}]}]},{"type":"SECONDARY","title":"Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)","description":"Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"46"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.428","spread":"2.172"},{"groupId":"OG001","value":"-0.362","spread":"1.733"}]}]}]},{"type":"SECONDARY","title":"Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)","description":"Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.747","spread":"2.245"},{"groupId":"OG001","value":"-0.397","spread":"1.594"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","description":"Change from baseline in body weight after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.48","spread":"5.59"},{"groupId":"OG001","value":"-0.87","spread":"3.84"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","description":"Change from baseline in body weight after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.27","spread":"8.05"},{"groupId":"OG001","value":"1.02","spread":"4.64"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in BMI Standard Deviation Score (SDS)","description":"Change in BMI SDS from baseline to week 52. BMI SDS was calculated using the following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"SDS score","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.361","spread":"0.542"},{"groupId":"OG001","value":"-0.166","spread":"0.330"}]}]}]},{"type":"SECONDARY","title":"Change in Blood Pressure (Systolic and Diastolic Blood Pressure)","description":"Change in blood pressure (systolic and diastolic blood pressure) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"}]}],"classes":[{"title":"Systolic Blood Pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-1.65","spread":"10.69"},{"groupId":"OG001","value":"0.03","spread":"10.05"}]}]},{"title":"Diastolic Blood Pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-1.27","spread":"8.39"},{"groupId":"OG001","value":"0.97","spread":"7.65"}]}]}]},{"type":"SECONDARY","title":"Change in Blood Pressure (Systolic and Diastolic Blood Pressure)","description":"Change in blood pressure (systolic and diastolic blood pressure) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"53"}]}],"classes":[{"title":"Systolic Blood Pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-0.77","spread":"11.77"},{"groupId":"OG001","value":"2.81","spread":"8.48"}]}]},{"title":"Diastolic Blood Pressure","categories":[{"measurements":[{"groupId":"OG000","value":"0.46","spread":"10.01"},{"groupId":"OG001","value":"1.83","spread":"7.26"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Fasting Insulin","description":"Ratio to baseline (fasting insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"57"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.9","spread":"76.4"},{"groupId":"OG001","value":"1.0","spread":"77.9"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Fasting Insulin","description":"Ratio to baseline (fasting insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.0","spread":"80.6"},{"groupId":"OG001","value":"1.1","spread":"142.8"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Fasting Pro-insulin","description":"Ratio to baseline (fasting pro-insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"55"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.62","spread":"110.3"},{"groupId":"OG001","value":"0.88","spread":"131.6"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Fasting Pro-insulin","description":"Ratio to baseline (fasting pro-insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"49"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.62","spread":"118.0"},{"groupId":"OG001","value":"0.79","spread":"121.0"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Pro-insulin/Insulin Ratio","description":"Ratio to baseline (Pro-insulin/insulin ratio) after week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. 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Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.690","spread":"102.4"},{"groupId":"OG001","value":"0.923","spread":"197.6"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Pro-insulin/Insulin Ratio","description":"Ratio to baseline (Pro-insulin/insulin ratio) after week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. 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Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"49"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.689","spread":"106.6"},{"groupId":"OG001","value":"0.770","spread":"225.1"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Fasting Glucagon","description":"Ratio to baseline (fasting glucagon) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"57"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.98","spread":"29.3"},{"groupId":"OG001","value":"1.03","spread":"32.4"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Fasting Glucagon","description":"Ratio to baseline (fasting glucagon) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. 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Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"52"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.01","spread":"35.0"},{"groupId":"OG001","value":"1.05","spread":"32.7"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Fasting C-peptide","description":"Ratio to baseline (fasting C-peptide) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.93","spread":"39.7"},{"groupId":"OG001","value":"0.84","spread":"82.3"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Fasting C-peptide","description":"Ratio to baseline (fasting C-peptide) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. 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After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"40.8"},{"groupId":"OG001","value":"0.83","spread":"56.5"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)","description":"Ratio to baseline (HOMA-B) after 26 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. 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Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"51"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.24","spread":"96.9"},{"groupId":"OG001","value":"1.01","spread":"119.0"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: HOMA-B","description":"Ratio to baseline (HOMA-B) after 52 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. 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After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"49"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.48","spread":"105.0"},{"groupId":"OG001","value":"0.93","spread":"166.8"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)","description":"Ratio to baseline (HOMA-IR) after 26 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. 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Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.73","spread":"80.5"},{"groupId":"OG001","value":"0.98","spread":"80.8"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: HOMA-IR","description":"Ratio to baseline (HOMA-IR) after 52 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. 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Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"52"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.82","spread":"86.4"},{"groupId":"OG001","value":"1.08","spread":"140.3"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Total Cholesterol","description":"Ratio to baseline (total cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. 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Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.975","spread":"17.7"},{"groupId":"OG001","value":"1.008","spread":"13.3"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Total Cholesterol","description":"Ratio to baseline (total cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. 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Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"52"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.013","spread":"21.0"},{"groupId":"OG001","value":"1.026","spread":"13.5"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol","description":"Ratio to baseline (LDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"57"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.998","spread":"24.8"},{"groupId":"OG001","value":"0.993","spread":"20.4"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: LDL Cholesterol","description":"Ratio to baseline (LDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.042","spread":"46.3"},{"groupId":"OG001","value":"1.035","spread":"21.5"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol","description":"Ratio to baseline (VLDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.890","spread":"51.6"},{"groupId":"OG001","value":"1.035","spread":"35.3"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: VLDL Cholesterol","description":"Ratio to baseline (VLDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"51"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.983","spread":"48.4"},{"groupId":"OG001","value":"1.003","spread":"45.5"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol","description":"Ratio to baseline (HDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.997","spread":"18.7"},{"groupId":"OG001","value":"0.981","spread":"16.3"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: HDL Cholesterol","description":"Ratio to baseline (HDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"51"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.028","spread":"16.0"},{"groupId":"OG001","value":"1.000","spread":"18.8"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Triglycerides","description":"Ratio to baseline (triglycerides) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.894","spread":"50.6"},{"groupId":"OG001","value":"1.038","spread":"36.0"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Triglycerides","description":"Ratio to baseline (triglycerides) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.964","spread":"50.5"},{"groupId":"OG001","value":"1.036","spread":"48.4"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Free Fatty Acids","description":"Ratio to baseline (free fatty acids) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.023","spread":"67.4"},{"groupId":"OG001","value":"0.985","spread":"47.5"}]}]}]},{"type":"SECONDARY","title":"Ratio to Baseline: Free Fatty Acids","description":"Ratio to baseline (free fatty acids) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Full analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"51"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.928","spread":"58.2"},{"groupId":"OG001","value":"0.868","spread":"54.8"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Pulse","description":"Change from baseline in pulse 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Safety analysis set - included all subjects receiving at least one dose of liraglutide/placebo (134 subjects). Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats/minute","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.40","spread":"10.89"},{"groupId":"OG001","value":"0.33","spread":"7.69"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Pulse","description":"Change from baseline in pulse 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Safety analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats/minute","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.05","spread":"10.39"},{"groupId":"OG001","value":"-0.28","spread":"7.88"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Height SDS","description":"Change in height SDS from baseline to week 26. Height SDS was calculated using the following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Safety analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"SDS score","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.100","spread":"0.133"},{"groupId":"OG001","value":"-0.042","spread":"0.210"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Height SDS","description":"Change in height SDS from baseline to week 52. Height SDS was calculated using the following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Safety analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"SDS score","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.192","spread":"0.223"},{"groupId":"OG001","value":"-0.134","spread":"0.293"}]}]}]},{"type":"SECONDARY","title":"Change in Bone Age Assessment (X-ray of Left Hand and Wrist)","description":"Change in bone age from baseline to week 52. If the baseline (week 0) bone age assessment indicated that all epiphyses were fused, then the assessment was not repeated at week 52.","populationDescription":"Safety analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"years","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.197","spread":"0.899"},{"groupId":"OG001","value":"1.088","spread":"0.889"}]}]}]},{"type":"SECONDARY","title":"Pubertal Assessment/Progression (Tanner Staging)","description":"Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of participants at different Tanner stages at week 0, week 26 and week 52.","populationDescription":"Safety analysis set. Number of participants analysed=participants with available data","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"68"}]}],"classes":[{"title":"Female - Breast development - Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"42"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"10"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"9"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"23"}]}]},{"title":"Female - Breast development - Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"36"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"10"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"22"}]}]},{"title":"Female - Breast development - Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"33"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"9"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"22"}]}]},{"title":"Male - Penis Development - Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"26"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"6"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"11"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"6"}]}]},{"title":"Male - Penis Development - Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"23"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"10"}]}]},{"title":"Male - Penis Development - Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"21"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"13"}]}]},{"title":"Pubic Hair Development - Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"67"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"10"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"25"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"29"}]}]},{"title":"Pubic Hair Development - Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"58"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"18"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"34"}]}]},{"title":"Pubic Hair Development - Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"53"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"17"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"34"}]}]}]},{"type":"SECONDARY","title":"Growth (Height Velocity)","description":"Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.","populationDescription":"Safety analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm/year","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.633","spread":"2.016"},{"groupId":"OG001","value":"2.486","spread":"2.834"}]}]}]},{"type":"SECONDARY","title":"Growth (Height Velocity)","description":"Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.","populationDescription":"Safety analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm/year","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.345","spread":"1.730"},{"groupId":"OG001","value":"1.817","spread":"2.043"}]}]}]},{"type":"SECONDARY","title":"Height Velocity SDS","description":"Height velocity SDS scores at week 26. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Safety analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"SDS score","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.24","spread":"1.695"},{"groupId":"OG001","value":"-0.557","spread":"2.058"}]}]}]},{"type":"SECONDARY","title":"Height Velocity SDS","description":"Height velocity SDS scores at week 52. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.","populationDescription":"Safety analysis set. Number of participants analysed=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"SDS score","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.887","spread":"1.460"},{"groupId":"OG001","value":"-0.551","spread":"1.711"}]}]}]},{"type":"SECONDARY","title":"Number of Hypoglycaemic Episodes","description":"Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 26.","populationDescription":"Safety analysis set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"hypoglycaemic episodes","timeFrame":"0-26 weeks","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"43"}]}]}]},{"type":"SECONDARY","title":"Number of Hypoglycaemic Episodes","description":"Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 52.","populationDescription":"Safety analysis set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"hypoglycaemic episodes","timeFrame":"0-52 weeks","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"63"}]}]}]},{"type":"SECONDARY","title":"Number of Adverse Events (Week 0-26)","description":"Total number of adverse events during 26 weeks.","populationDescription":"Safety analysis set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events","timeFrame":"0-26 weeks","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"230"}]}]}]},{"type":"SECONDARY","title":"Number of Adverse Events (Week 0-52)","description":"Total number of adverse events during entire treatment period.","populationDescription":"Safety analysis set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events","timeFrame":"0-52 weeks","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"426"},{"groupId":"OG001","value":"321"}]}]}]},{"type":"SECONDARY","title":"Number of Serious Adverse Events (Week 0-26)","description":"Total number of serious adverse events during 26 weeks.","populationDescription":"Safety analysis set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events","timeFrame":"0-26 weeks","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"}]}]}]},{"type":"SECONDARY","title":"Number of Serious Adverse Events (Week 0-52)","description":"Total number of serious adverse events during entire treatment period.","populationDescription":"Safety analysis set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events","timeFrame":"0-52 weeks","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52)."},{"id":"OG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"5"}]}]}]},{"type":"SECONDARY","title":"Number of Adverse Events (Week 53-104)","description":"This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during follow-up 1 (week 53 to 104).","populationDescription":"Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events","timeFrame":"Week 53-104","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg: Follow-up 1","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"30"}]}]}]},{"type":"SECONDARY","title":"Number of Serious Adverse Events (Week 53-104)","description":"This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during follow up 1 (week 53 to 104).","populationDescription":"Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events","timeFrame":"Weeks 53-104","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg: Follow-up 1","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}]}]},{"type":"SECONDARY","title":"Growth (Height Velocity)- Week 104","description":"Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.","populationDescription":"Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm/year","timeFrame":"Week 0, week 104","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg: Follow-up 1","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.149","spread":"1.776"}]}]}]},{"type":"SECONDARY","title":"Height Velocity SDS- Week 104","description":"The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.","populationDescription":"Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"SDS score","timeFrame":"Week 0, week 104","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg: Follow-up 1","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.523","spread":"1.466"}]}]}]},{"type":"SECONDARY","title":"Change From Week 52 in Height SDS- Week 104","description":"Change in height SDS from week 52 to week 104. Height SDS was calculated using the following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.","populationDescription":"Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"SDS score","timeFrame":"Week 52, week 104","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg: Follow-up 1","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"49"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.133","spread":"0.338"}]}]}]},{"type":"SECONDARY","title":"Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104","description":"Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents \"pre-adoloscent development\" and stage V represents \"pubertal development equivalent to that of an adult\". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.","populationDescription":"Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Number analyzed= subjects with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 52, week 104","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg: Follow-up 1","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"}]}],"classes":[{"title":"Female- Breast development- Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"1"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"5"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"21"}]}]},{"title":"Female- Breast development- Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"5"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"11"}]}]},{"title":"Male- Penis development- Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"1"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"2"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"7"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"14"}]}]},{"title":"Male- Penis development- Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"1"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"5"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"8"}]}]},{"title":"Female- Pubic hair development- Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"2"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"2"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"22"}]}]},{"title":"Female- Pubic hair development- Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"1"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"2"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"13"}]}]},{"title":"Male- Pubic hair development- Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"1"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"1"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"2"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"6"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"14"}]}]},{"title":"Male- Pubic hair development- Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"1"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"4"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"9"}]}]}]},{"type":"SECONDARY","title":"Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104","description":"Change in bone age from week 52 to week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.","populationDescription":"Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Years","timeFrame":"Week 52, week 104","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg: Follow-up 1","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.231","spread":"0.992"}]}]}]},{"type":"SECONDARY","title":"Number of Adverse Events (Week 53-156)","description":"This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during the follow-up period (weeks 53 to 156).","populationDescription":"Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during weeks 53-156.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events","timeFrame":"Week 53-156","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg: Follow-up 1 and 2","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at weeks 104 and 156."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"47"}]}]}]},{"type":"SECONDARY","title":"Number of Serious Adverse Events (Week 53-156)","description":"This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during the follow up period (week 53 to 156).","populationDescription":"Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during weeks 53-156.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events","timeFrame":"Weeks 53-156","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg: Follow-up 1 and 2","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at weeks 104 and 156."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}]}]},{"type":"SECONDARY","title":"Growth (Height Velocity)- Week 156","description":"Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.","populationDescription":"Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm/year","timeFrame":"Week 0, week 156","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg: Follow-up 1 and 2","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at weeks 104 and 156."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"45"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.100","spread":"1.504"}]}]}]},{"type":"SECONDARY","title":"Height Velocity SDS- Week 156","description":"The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.","populationDescription":"Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"SDS score","timeFrame":"Week 0, week 156","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg: Follow-up 1 and 2","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at weeks 104 and 156."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.142","spread":"1.156"}]}]}]},{"type":"SECONDARY","title":"Change From Week 52 in Height SDS- Week 156","description":"Change in height SDS from week 52 to week 156. Height SDS was calculated using the following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.","populationDescription":"Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"SDS score","timeFrame":"Week 52, week 156","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg: Follow-up 1 and 2","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at weeks 104 and 156."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.224","spread":"0.446"}]}]}]},{"type":"SECONDARY","title":"Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156","description":"Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents \"pre-adoloscent development\" and stage V represents \"pubertal development equivalent to that of an adult\". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.","populationDescription":"Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Number analyzed= subjects with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 52, week 156","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg: Follow-up 1 and 2","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at weeks 104 and 156."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"}]}],"classes":[{"title":"Female- Breast development- Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"1"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"5"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"21"}]}]},{"title":"Female- Breast development- Week 156","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"3"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"11"}]}]},{"title":"Male- Penis development- Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"1"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"2"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"7"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"14"}]}]},{"title":"Male- Penis development- Week 156","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"1"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"3"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"9"}]}]},{"title":"Female- Pubic hair development- Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"2"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"2"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"22"}]}]},{"title":"Female- Pubic hair development- Week 156","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"2"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"11"}]}]},{"title":"Male- Pubic hair development- Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"1"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"1"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"2"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"6"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"14"}]}]},{"title":"Male- Pubic hair development- Week 156","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"}]}],"categories":[{"title":"Stage I","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage II","measurements":[{"groupId":"OG000","value":"0"}]},{"title":"Stage III","measurements":[{"groupId":"OG000","value":"1"}]},{"title":"Stage IV","measurements":[{"groupId":"OG000","value":"3"}]},{"title":"Stage V","measurements":[{"groupId":"OG000","value":"10"}]}]}]},{"type":"SECONDARY","title":"Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156","description":"Change in bone age from week 52 to week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.","populationDescription":"Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Years","timeFrame":"Week 52, week 156","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg: Follow-up 1 and 2","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at weeks 104 and 156."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.778","spread":"1.277"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Week 0 - 156. All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration.","description":"Adverse events were reported per reporting group for treatment period and follow up period. Results are based on SAS which included subjects: who received at least one dose of liraglutide or placebo for \"Liraglutide 1.8 mg- Treatment period\" and \"Placebo\" and who received liraglutide for more than 3 months during treatment period (week 0-52) and provided follow-up data anytime during weeks 53-104 for \"Liraglutide 1.8 mg: Follow-up 1\" and weeks 105-156 for \"Liraglutide 1.8 mg: Follow-up 2\".","eventGroups":[{"id":"EG000","title":"Liraglutide 1.8 mg","description":"After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \\>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).","deathsNumAffected":0,"deathsNumAtRisk":66,"seriousNumAffected":9,"seriousNumAtRisk":66,"otherNumAffected":45,"otherNumAtRisk":66},{"id":"EG001","title":"Placebo","description":"After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.","deathsNumAffected":0,"deathsNumAtRisk":68,"seriousNumAffected":4,"seriousNumAtRisk":68,"otherNumAffected":49,"otherNumAtRisk":68},{"id":"EG002","title":"Liraglutide 1.8 mg: Follow-up 1","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104.","deathsNumAffected":0,"deathsNumAtRisk":52,"seriousNumAffected":7,"seriousNumAtRisk":52,"otherNumAffected":7,"otherNumAtRisk":52},{"id":"EG003","title":"Liraglutide 1.8 mg: Follow-up 2","description":"Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 156.","deathsNumAffected":0,"deathsNumAtRisk":48,"seriousNumAffected":2,"seriousNumAtRisk":48,"otherNumAffected":1,"otherNumAtRisk":48}],"seriousEvents":[{"term":"Abdominal 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