{"protocolSection":{"identificationModule":{"nctId":"NCT01336023","orgStudyIdInfo":{"id":"NN9068-3697"},"secondaryIdInfos":[{"id":"U1111-1119-1174","type":"OTHER","domain":"WHO"},{"id":"2010-021560-15","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes","officialTitle":"A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension","acronym":"DUAL™ I"},"statusModule":{"statusVerifiedDate":"2018-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-05-23","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2012-05-24","type":"ACTUAL"},"completionDateStruct":{"date":"2012-11-22","type":"ACTUAL"},"studyFirstSubmitDate":"2011-04-13","studyFirstSubmitQcDate":"2011-04-14","studyFirstPostDateStruct":{"date":"2011-04-15","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-12-12","resultsFirstSubmitQcDate":"2017-04-26","resultsFirstPostDateStruct":{"date":"2017-06-02","type":"ACTUAL"},"dispFirstSubmitDate":"2012-12-19","dispFirstSubmitQcDate":"2012-12-19","dispFirstPostDateStruct":{"date":"2012-12-24","type":"ESTIMATED"},"lastUpdateSubmitDate":"2018-02-16","lastUpdatePostDateStruct":{"date":"2018-02-19","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is conducted globally. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide (Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":1663,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"IDeg","type":"EXPERIMENTAL","interventionNames":["Drug: insulin degludec"]},{"label":"IDegLira","type":"EXPERIMENTAL","interventionNames":["Drug: insulin degludec/liraglutide"]},{"label":"Lira","type":"EXPERIMENTAL","interventionNames":["Drug: liraglutide"]}],"interventions":[{"type":"DRUG","name":"insulin degludec/liraglutide","description":"Insulin degludec/liraglutide treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). Insulin degludec/liraglutide is injected subcutaneously (under the skin) once daily.","armGroupLabels":["IDegLira"]},{"type":"DRUG","name":"insulin degludec","description":"Insulin degludec treatment will be initiated with 10 U and titrated (individually adjusted) twice weekly according to the mean SMPG (fasting). Insulin degludec is injected subcutaneously (under the skin) once daily.","armGroupLabels":["IDeg"]},{"type":"DRUG","name":"liraglutide","description":"Liraglutide will be started with 0.6 mg and subsequent 0.6 mg weekly dose escalation to 1.8 mg. Liraglutide dose of 1.8 mg/day will be continued for the remaining part of the trial. Liraglutide is injected subcutaneously (under the skin) once daily.","armGroupLabels":["Lira"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.","description":"Values of mean change in HbA1c.","timeFrame":"Week 0, week 26"}],"secondaryOutcomes":[{"measure":"Mean Change From Baseline in Body Weight at Week 26","description":"Values of mean change in body weight.","timeFrame":"Week 0, Week 26"},{"measure":"Number of Hypoglycaemic Episodes","description":"Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.","timeFrame":"Weeks 0-26"},{"measure":"Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test","description":"Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Actual Daily Insulin Dose","description":"Mean of the actual doses recorded at visit 28 (Week 26).","timeFrame":"Week 26"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Subjects with type 2 diabetes\n* HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly, when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%\n* Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 in Taiwan: Taichung Veterans General Hospital)\n* Subjects on stable dose of 1-2 OADs (metformin \\[at least 1500 mg or max tolerated dose\\] or metformin \\[at least 1500 mg or max tolerated dose\\] + pioglitazone \\[at least 30 mg\\]) for at least 90 days prior to screening\n* Body Mass Index (BMI) maximum 40 kg/m\\^2\n\nExclusion Criteria:\n\n* Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator)\n* Treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90 days prior to trial\n* Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 times Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)\n* Impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)\n* Screening calcitonin at least 50 ng/L\n* Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)\n* Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina 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Efficacy and Safety of IDegLira in Participants with Type 2 Diabetes in India Uncontrolled on Oral Antidiabetic Drugs and Basal Insulin: Data from the DUAL Clinical Trial Program. Diabetes Ther. 2017 Jun;8(3):673-682. doi: 10.1007/s13300-017-0252-9. Epub 2017 Mar 22."},{"pmid":"26443290","type":"RESULT","citation":"Holst JJ, Buse JB, Rodbard HW, Linjawi S, Woo VC, Boesgaard TW, Kvist K, Gough SC. IDegLira Improves Both Fasting and Postprandial Glucose Control as Demonstrated Using Continuous Glucose Monitoring and a Standardized Meal Test. J Diabetes Sci Technol. 2015 Oct 6;10(2):389-97. doi: 10.1177/1932296815610124."},{"pmid":"26894800","type":"RESULT","citation":"Vilsboll T, Vora J, Jarlov H, Kvist K, Blonde L. Type 2 Diabetes Patients Reach Target Glycemic Control Faster Using IDegLira than Either Insulin Degludec or Liraglutide Given Alone. Clin Drug Investig. 2016 Apr;36(4):293-303. doi: 10.1007/s40261-016-0376-0."},{"pmid":"25190523","type":"RESULT","citation":"Gough SC, Bode B, Woo V, Rodbard HW, Linjawi S, Poulsen P, Damgaard LH, Buse JB; NN9068-3697 (DUAL-I) trial investigators. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes. Lancet Diabetes Endocrinol. 2014 Nov;2(11):885-93. doi: 10.1016/S2213-8587(14)70174-3. Epub 2014 Sep 1."},{"pmid":"25980900","type":"RESULT","citation":"Gough SC, Bode BW, Woo VC, Rodbard HW, Linjawi S, Zacho M, Reiter PD, Buse JB. One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial. Diabetes Obes Metab. 2015 Oct;17(10):965-73. doi: 10.1111/dom.12498. Epub 2015 Jul 1."},{"pmid":"25998481","type":"RESULT","citation":"Kapitza C, Bode B, Ingwersen SH, Jacobsen LV, Poulsen P. Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy. J Clin Pharmacol. 2015 Dec;55(12):1369-77. doi: 10.1002/jcph.549. Epub 2015 Jul 14."},{"pmid":"28282219","type":"RESULT","citation":"King AB, Philis-Tsimikas A, Kilpatrick ES, Langbakke IH, Begtrup K, Vilsboll T. A Fixed Ratio Combination of Insulin Degludec and Liraglutide (IDegLira) Reduces Glycemic Fluctuation and Brings More Patients with Type 2 Diabetes Within Blood Glucose Target Ranges. Diabetes Technol Ther. 2017 Apr;19(4):255-264. doi: 10.1089/dia.2016.0405. Epub 2017 Mar 10."},{"pmid":"28417535","type":"RESULT","citation":"Norwood P, Chen R, Jaeckel E, Lingvay I, Jarlov H, Lehmann L, Heller S. Rates of hypoglycaemia are lower in patients treated with insulin degludec/liraglutide (IDegLira) than with IDeg or insulin glargine, regardless of the hypoglycaemia definition used. Diabetes Obes Metab. 2017 Nov;19(11):1562-1569. doi: 10.1111/dom.12972. Epub 2017 Jul 10."},{"pmid":"39963952","type":"DERIVED","citation":"Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Subjects on metformin and/or pioglitazone treatment underwent a 26-week main trial and continued to enter an additional 26-week extension trial. Total duration of the trial was up to 55 weeks (2 weeks screening + 26 week main period + 26 week extension period + 1 week follow-up after last dose).","recruitmentDetails":"Countries: 19; Sites: 271; Number of sites as in parenthesis. Australia (7), Canada (14 ), Finland (5 ), Germany (12 ), Hungary (6), India (23), Ireland (2), Italy (6), Malaysia (5), Mexico (2 ), Russian Federation (11), Singapore (3), Slovakia (5), South Africa (13), Spain (8), Taiwan (3), Thailand (4), United Kingdom (16) and United States (126).","groups":[{"id":"FG000","title":"IDeg","description":"Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."},{"id":"FG001","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."},{"id":"FG002","title":"Liraglutide","description":"Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."}],"periods":[{"title":"Week 0 to Week 26","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"414"},{"groupId":"FG001","numSubjects":"834"},{"groupId":"FG002","numSubjects":"415"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","comment":"1 subject withdrew before exposure to trial drug and was not included in the analysis","numSubjects":"413"},{"groupId":"FG001","comment":"8 subjects withdrew before exposure to trial drug and were not included in the analysis","numSubjects":"826"},{"groupId":"FG002","comment":"2 subjects withdrew before exposure to trial drug and were not included in the analysis","numSubjects":"413"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"366"},{"groupId":"FG001","numSubjects":"736"},{"groupId":"FG002","numSubjects":"342"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"98"},{"groupId":"FG002","numSubjects":"73"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"24"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal Criteria","reasons":[{"groupId":"FG000","numSubjects":"34"},{"groupId":"FG001","numSubjects":"69"},{"groupId":"FG002","numSubjects":"40"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"16"},{"groupId":"FG002","numSubjects":"9"}]}]},{"title":"Week 27 to 52","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"From the main trial, 33 subjects were not enrolled in the extension (week 27-52).","numSubjects":"333"},{"groupId":"FG001","comment":"From the main trial, 71 subjects were not enrolled in the extension (week 27-52).","numSubjects":"665"},{"groupId":"FG002","comment":"From the main trial, 29 subjects were not enrolled in the extension (week 27-52).","numSubjects":"313"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"305"},{"groupId":"FG001","numSubjects":"621"},{"groupId":"FG002","numSubjects":"285"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"44"},{"groupId":"FG002","numSubjects":"28"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Withdrawal Criteria","reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"19"},{"groupId":"FG002","numSubjects":"16"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"9"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). Three subjects did not have their case book signed off due to discontinuation of an investigator's participation in the trial, hence 1 subject in each arm was excluded from the FAS.","groups":[{"id":"BG000","title":"IDeg","description":"Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."},{"id":"BG001","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."},{"id":"BG002","title":"Liraglutide","description":"Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"413"},{"groupId":"BG001","value":"833"},{"groupId":"BG002","value":"414"},{"groupId":"BG003","value":"1660"}]}],"measures":[{"title":"Age, Continuous","populationDescription":"The number of subjects analysed in the IDeg, IDegLira and Liraglutide arms 413, 833 and 413, respectively.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"413"},{"groupId":"BG001","value":"833"},{"groupId":"BG002","value":"413"},{"groupId":"BG003","value":"1659"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"54.9","spread":"9.7"},{"groupId":"BG001","value":"55.1","spread":"9.9"},{"groupId":"BG002","value":"55.0","spread":"10.2"},{"groupId":"BG003","value":"55.0","spread":"9.9"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"413"},{"groupId":"BG001","value":"833"},{"groupId":"BG002","value":"414"},{"groupId":"BG003","value":"1660"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"213"},{"groupId":"BG001","value":"398"},{"groupId":"BG002","value":"206"},{"groupId":"BG003","value":"817"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"200"},{"groupId":"BG001","value":"435"},{"groupId":"BG002","value":"208"},{"groupId":"BG003","value":"843"}]}]}]},{"title":"Body Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"413"},{"groupId":"BG001","value":"833"},{"groupId":"BG002","value":"414"},{"groupId":"BG003","value":"1660"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"87.4","spread":"19.2"},{"groupId":"BG001","value":"87.2","spread":"19.0"},{"groupId":"BG002","value":"87.4","spread":"18.0"},{"groupId":"BG003","value":"87.3","spread":"18.8"}]}]}]},{"title":"Normalised Incremental Area under curve (AUC)","description":"The area under the glucose concentration (AUC) curve during 0-4 hours after the start of a standardised meal. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L. The data was derived from the subjects who underwent a standard meal test conducted at selected sites.","populationDescription":"The number of subjects analysed in the IDeg, IDegLira and Liraglutide arms 63, 128 and 61, respectively.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"63"},{"groupId":"BG001","value":"128"},{"groupId":"BG002","value":"61"},{"groupId":"BG003","value":"252"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"4.12","spread":"1.80"},{"groupId":"BG001","value":"4.11","spread":"2.05"},{"groupId":"BG002","value":"4.12","spread":"1.82"},{"groupId":"BG003","value":"4.11","spread":"1.93"}]}]}]},{"title":"Glycosylated haemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of glycosylated haemoglobin","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"413"},{"groupId":"BG001","value":"833"},{"groupId":"BG002","value":"414"},{"groupId":"BG003","value":"1660"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"8.3","spread":"1.0"},{"groupId":"BG001","value":"8.3","spread":"0.9"},{"groupId":"BG002","value":"8.3","spread":"0.9"},{"groupId":"BG003","value":"8.3","spread":"0.9"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.","description":"Values of mean change in HbA1c.","populationDescription":"The FAS included all randomised subjects and missing data was imputed using LOCF. Three subjects did not have their case book signed off due to discontinuation of an investigator's participation in the trial; hence 1 subject from each arm was excluded from the FAS.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of glycosylated haemoglobin","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"IDeg","description":"Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."},{"id":"OG001","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."},{"id":"OG002","title":"Liraglutide","description":"Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"413"},{"groupId":"OG001","value":"833"},{"groupId":"OG002","value":"414"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.44","spread":"1.03"},{"groupId":"OG001","value":"-1.91","spread":"1.07"},{"groupId":"OG002","value":"-1.28","spread":"1.13"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"Non-inferiority of IDegLira vs. IDeg was confirmed when 95% confidence interval for the treatment differences for change in HbA1c lies entirely below 0.3%.\n\nIDegLira minus IDeg","statisticalMethod":"ANCOVA","paramType":"Treatment Contrast","paramValue":"-0.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.58","ciUpperLimit":"-0.36","estimateComment":"IDegLira minus IDeg"},{"groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Superiority of IDegLira over liraglutide was confirmed when the 95% confidence interval for the treatment difference for change in HbA1c lies entirely below 0%.\n\nIDegLira minus Liraglutide","statisticalMethod":"ANCOVA","paramType":"Treatment contrast","paramValue":"-0.64","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.75","ciUpperLimit":"-0.53","estimateComment":"IDegLira minus Liraglutide"}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Body Weight at Week 26","description":"Values of mean change in body weight.","populationDescription":"The FAS included all randomised subjects and missing data was imputed using LOCF. Three subjects did not have their case book signed off due to discontinuation of an investigator's participation in the trial; hence 1 subject from each arm was excluded from the FAS.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"IDeg","description":"Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."},{"id":"OG001","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."},{"id":"OG002","title":"Liraglutide","description":"Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"413"},{"groupId":"OG001","value":"833"},{"groupId":"OG002","value":"414"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.6","spread":"4.0"},{"groupId":"OG001","value":"-0.5","spread":"3.5"},{"groupId":"OG002","value":"-3.0","spread":"3.5"}]}]}]},{"type":"SECONDARY","title":"Number of Hypoglycaemic Episodes","description":"Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.","populationDescription":"The Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparators. The missing data was imputed using LOCF. The number of subjects analysed in SAS for each arm are 412, 825 and 412, respectively.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events per 100 patient years of exposure","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"IDeg","description":"Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."},{"id":"OG001","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."},{"id":"OG002","title":"Liraglutide","description":"Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"412"},{"groupId":"OG001","value":"825"},{"groupId":"OG002","value":"412"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"256.7"},{"groupId":"OG001","value":"180.2"},{"groupId":"OG002","value":"22.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test","description":"Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point.","populationDescription":"The number of subjects analysed were equal to study population in which the meal test was perfomed at selected sites. Missing data was imputed using LOCF.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"IDeg","description":"Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."},{"id":"OG001","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."},{"id":"OG002","title":"Liraglutide","description":"Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"128"},{"groupId":"OG002","value":"61"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.17","spread":"1.98"},{"groupId":"OG001","value":"-0.87","spread":"1.65"},{"groupId":"OG002","value":"-0.78","spread":"1.62"}]}]}]},{"type":"SECONDARY","title":"Mean Actual Daily Insulin Dose","description":"Mean of the actual doses recorded at visit 28 (Week 26).","populationDescription":"The FAS included all randomised subjects. Missing data was imputed using LOCF. For 22 subjects, the dose values were missing hence did not contribute to the analysis. The comparison was made between the insulin products IDeg and IDeglira.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units","timeFrame":"Week 26","groups":[{"id":"OG000","title":"IDeg","description":"Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."},{"id":"OG001","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"408"},{"groupId":"OG001","value":"816"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"53","spread":"28"},{"groupId":"OG001","value":"38","spread":"13"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Adverse events (AEs) were collected from first day of exposure to randomised treatment of 52 weeks (26 week main period + 26 week extension period) + 7 days follow-up after the last day on randomised treatment.","description":"The Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparators.","eventGroups":[{"id":"EG000","title":"IDeg","description":"Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.","seriousNumAffected":22,"seriousNumAtRisk":412,"otherNumAffected":160,"otherNumAtRisk":412},{"id":"EG001","title":"IDegLira","description":"Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.","seriousNumAffected":38,"seriousNumAtRisk":825,"otherNumAffected":386,"otherNumAtRisk":825},{"id":"EG002","title":"Liraglutide","description":"Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.","seriousNumAffected":24,"seriousNumAtRisk":412,"otherNumAffected":241,"otherNumAtRisk":412}],"seriousEvents":[{"term":"Acute coronary syndrome","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":412},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":825},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":412}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":412},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":825},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":412}]},{"term":"Angina pectoris","organSystem":"Cardiac 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