{"protocolSection":{"identificationModule":{"nctId":"NCT00518882","orgStudyIdInfo":{"id":"NN2211-1797"},"secondaryIdInfos":[{"id":"2006-006092-21","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes","officialTitle":"Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes","acronym":"LEAD-6"},"statusModule":{"statusVerifiedDate":"2017-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-08"},"primaryCompletionDateStruct":{"date":"2008-04","type":"ACTUAL"},"completionDateStruct":{"date":"2009-04","type":"ACTUAL"},"studyFirstSubmitDate":"2007-08-20","studyFirstSubmitQcDate":"2007-08-20","studyFirstPostDateStruct":{"date":"2007-08-21","type":"ESTIMATED"},"resultsFirstSubmitDate":"2010-02-23","resultsFirstSubmitQcDate":"2010-02-23","resultsFirstPostDateStruct":{"date":"2010-03-23","type":"ESTIMATED"},"dispFirstSubmitDate":"2009-11-09","dispFirstSubmitQcDate":"2009-11-09","dispFirstPostDateStruct":{"date":"2009-11-11","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-01-25","lastUpdatePostDateStruct":{"date":"2017-03-08","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":467,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Liraglutide","type":"EXPERIMENTAL","description":"Liraglutide 1.8 mg once daily + subject's own OAD treatment","interventionNames":["Drug: liraglutide"]},{"label":"Exenatide","type":"ACTIVE_COMPARATOR","description":"Exenatide 10 mcg twice daily + subject's own OAD treatment","interventionNames":["Drug: exenatide"]}],"interventions":[{"type":"DRUG","name":"liraglutide","description":"1.8 mg once daily for s.c. (under the skin) injection.","armGroupLabels":["Liraglutide"]},{"type":"DRUG","name":"exenatide","description":"10 mcg twice daily for s.c. (under the skin) injection.","armGroupLabels":["Exenatide"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Glycosylated A1c (HbA1c) at Week 26","description":"Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)","timeFrame":"week 0, week 26"}],"secondaryOutcomes":[{"measure":"Change in Glycosylated A1c (HbA1c), Weeks 26-78","description":"Percentage point change in glycosylated A1c (HbA1c) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group)","timeFrame":"week 26, week 78"},{"measure":"Change in Glycosylated A1c (HbA1c) at Week 78","description":"Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group)","timeFrame":"week 0, week 78"},{"measure":"Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26","description":"Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 26 (end of randomisation)","timeFrame":"week 0, week 26"},{"measure":"Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78","description":"Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 78 (end of treatment)","timeFrame":"week 0, week 78"},{"measure":"Change in Body Weight at Week 26","description":"Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)","timeFrame":"week 0, week 26"},{"measure":"Change in Body Weight, Weeks 26-78","description":"Change in body weight from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group)","timeFrame":"week 26, week 78"},{"measure":"Change in Body Weight at Week 78","description":"Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group)","timeFrame":"week 0, week 78"},{"measure":"Change in Fasting Plasma Glucose at Week 26","description":"Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)","timeFrame":"week 0, week 26"},{"measure":"Change in Fasting Plasma Glucose, Weeks 26-78","description":"Change in fasting plasma glucose from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group)","timeFrame":"week 26, week 78"},{"measure":"Change in Fasting Plasma Glucose at Week 78","description":"Change in fasting plasma glucose from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group)","timeFrame":"week 0, week 78"},{"measure":"Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26","description":"Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after breakfast.","timeFrame":"week 0, week 26"},{"measure":"Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26","description":"Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.","timeFrame":"week 0, week 26"},{"measure":"Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26","description":"Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.","timeFrame":"week 0, week 26"},{"measure":"Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78","description":"Change in mean prandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.","timeFrame":"week 26, week 78"},{"measure":"Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78","description":"Change in mean prandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after a lunch.","timeFrame":"week 26, week 78"},{"measure":"Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78","description":"Change in mean prandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.","timeFrame":"week 26, week 78"},{"measure":"Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78","description":"Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.","timeFrame":"week 0, week 78"},{"measure":"Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78","description":"Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.","timeFrame":"week 0, week 78"},{"measure":"Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78","description":"Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.","timeFrame":"week 0, week 78"},{"measure":"Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26","description":"Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.","timeFrame":"week 0, week 26"},{"measure":"Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26","description":"Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.","timeFrame":"week 0. week 26"},{"measure":"Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26","description":"Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.","timeFrame":"week 0, week 26"},{"measure":"Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78","description":"Change in mean postprandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.","timeFrame":"week 26, week 78"},{"measure":"Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78","description":"Change in mean postprandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.","timeFrame":"week 26, week 78"},{"measure":"Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78","description":"Change in mean postprandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.","timeFrame":"week 26, week 78"},{"measure":"Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78","description":"Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.","timeFrame":"week 0, week 78"},{"measure":"Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78","description":"Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.","timeFrame":"week 0, week 78"},{"measure":"Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78","description":"Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.","timeFrame":"week 0, week 78"},{"measure":"Change in Beta-cell Function at Week 26","description":"Change in Beta-cell function from baseline (week 0) to 26 weeks (end of randomisation). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).\n\nBeta-cell function: HOMA-B (%) = 20∙fasting insulin\\[uU/mL\\] divided by (FPG mmol/L\\]-3.5).","timeFrame":"week 0, week 26"},{"measure":"Change in Beta-cell Function, Weeks 26-78","description":"Change in Beta-cell function from Week 26 (end of randomisation) to Week 78 (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).\n\nBeta-cell function: HOMA-B (%) = 20∙fasting insulin\\[uU/mL\\] divided by (FPG mmol/L\\]-3.5).","timeFrame":"week 26, week 78"},{"measure":"Change in Beta-cell Function at Week 78","description":"Change in Beta-cell function from baseline (week 0) to 78 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).\n\nBeta-cell function: HOMA-B (%) = 20∙fasting insulin\\[uU/mL\\] divided by (FPG mmol/L\\]-3.5).","timeFrame":"week 0, week 78"},{"measure":"Change in Total Cholesterol at Week 26","description":"Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation)","timeFrame":"week 0, week 26"},{"measure":"Change in Total Cholesterol, Weeks 26-78","description":"Change in total cholesterol (TC) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","timeFrame":"week 26, week 78"},{"measure":"Change in Total Cholesterol at Week 78","description":"Change in total cholesterol (TC) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","timeFrame":"week 0, week 78"},{"measure":"Change in Low-density Lipoprotein-cholesterol at Week 26","description":"Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 26 weeks (end of randomisation)","timeFrame":"week 0, week 26"},{"measure":"Change in Low-density Lipoprotein-cholesterol, Weeks 26-78","description":"Change in low-density lipoprotein-cholesterol (LDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","timeFrame":"week 26, week 78"},{"measure":"Change in Low-density Lipoprotein-cholesterol at Week 78","description":"Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","timeFrame":"week 0, week 78"},{"measure":"Change in Very Low-density Lipoprotein-cholesterol at Week 26","description":"Change in very low-density lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 26 weeks (end of randomisation)","timeFrame":"week 0, week 26"},{"measure":"Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78","description":"Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","timeFrame":"week 26, week 78"},{"measure":"Change in Very Low-density Lipoprotein-cholesterol at Week 78","description":"Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","timeFrame":"week 0, week 78"},{"measure":"Change in High-density Lipoprotein-cholesterol at Week 26","description":"Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 26 weeks (end of randomisation)","timeFrame":"week 0, week 26"},{"measure":"Change in High-density Lipoprotein-cholesterol, Weeks 26-78","description":"Change in High-density Lipoprotein-cholesterol (HDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","timeFrame":"week 26, week 78"},{"measure":"Change in High-density Lipoprotein-cholesterol at Week 78","description":"Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","timeFrame":"week 0, week 78"},{"measure":"Change in Triglyceride at Week 26","description":"Change in triglyceride (TG) from from baseline (week 0) to 26 weeks (end of randomisation)","timeFrame":"week 0, week 26"},{"measure":"Change in Triglyceride, Weeks 26-78","description":"Change in Triglyceride (TG) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","timeFrame":"week 26, week 78"},{"measure":"Change in Triglyceride at Week 78","description":"Change in triglyceride (TG) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","timeFrame":"week 0, week 78"},{"measure":"Change in Free Fatty Acid at Week 26","description":"Change in Free Fatty Acid (FFA) from baseline (week 0) to 26 weeks (end of randomisation)","timeFrame":"week 0, week 26"},{"measure":"Change in Free Fatty Acid, Weeks 26-78","description":"Change in Free Fatty Acid (FFA) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","timeFrame":"week 26, week 78"},{"measure":"Change in Free Fatty Acid at Week 78","description":"Change in Free Fatty Acid (FFA) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","timeFrame":"week 0, week 78"},{"measure":"Change in Apolipoprotein B at Week 26","description":"Change in apolipoprotein B (ApoB) from baseline (week 0) to 26 weeks (end of randomisation)","timeFrame":"week 0, week 26"},{"measure":"Change in Apolipoprotein B, Weeks 26-78","description":"Change in apolipoprotein B (ApoB) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","timeFrame":"week 26, week 78"},{"measure":"Change in Apolipoprotein B at Week 78","description":"Change in apolipoprotein B (ApoB) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","timeFrame":"week 0, week 78"},{"measure":"Hypoglycaemic Episodes at Week 26","description":"Total number of hypoglycaemic episodes occurring after baseline (week 0) and until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","timeFrame":"weeks 0-26"},{"measure":"Hypoglyceamic Episodes, Weeks 26-78","description":"Total number of hypoglycaemic episodes occurring after end of randomisation (week 26) and until week 78 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","timeFrame":"weeks 26-78"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Type 2 diabetes\n* Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator\n* HbA1C equal to or greater than 7.0% and equal to or lower than 11.0%\n* Body Mass Index (BMI) equal to or lower than 45.0 kg/m2\n\nExclusion Criteria:\n\n* Previous treatment with insulin\n* Treatment with any anti-diabetic drug other than metformin and sulphonylurea\n* Any previous exposure to exenatide or liraglutide\n* Impaired liver or/and renal function\n* History of any significant cardiac events\n* Known retinopathy or maculopathy requiring acute treatment\n* Recurrent major hypoglycaemia or hypoglycaemic unawareness","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"80 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Global Clinical Registry (GCR, 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Birmingham","state":"Alabama","zip":"35242","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Novo Nordisk Investigational Site","city":"Goodyear","state":"Arizona","zip":"85395","country":"United States","geoPoint":{"lat":33.43532,"lon":-112.35821}},{"facility":"Novo Nordisk Investigational Site","city":"Artesia","state":"California","zip":"90701","country":"United States","geoPoint":{"lat":33.86585,"lon":-118.08312}},{"facility":"Novo Nordisk Investigational Site","city":"Encino","state":"California","zip":"91436","country":"United States","geoPoint":{"lat":34.15917,"lon":-118.50119}},{"facility":"Novo Nordisk Investigational Site","city":"Escondido","state":"California","zip":"92025","country":"United States","geoPoint":{"lat":33.11921,"lon":-117.08642}},{"facility":"Novo Nordisk Investigational Site","city":"Los Angeles","state":"California","zip":"90057","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Novo Nordisk Investigational Site","city":"Orange","state":"California","zip":"92869","country":"United States","geoPoint":{"lat":33.78779,"lon":-117.85311}},{"facility":"Novo Nordisk Investigational Site","city":"Sacramento","state":"California","zip":"95816","country":"United States","geoPoint":{"lat":38.58157,"lon":-121.4944}},{"facility":"Novo Nordisk Investigational Site","city":"San Mateo","state":"California","zip":"94401","country":"United States","geoPoint":{"lat":37.56299,"lon":-122.32553}},{"facility":"Novo Nordisk Investigational Site","city":"Spring Valley","state":"California","zip":"91978","country":"United States","geoPoint":{"lat":32.74477,"lon":-116.99892}},{"facility":"Novo Nordisk Investigational Site","city":"Walnut Creek","state":"California","zip":"94598","country":"United States","geoPoint":{"lat":37.90631,"lon":-122.06496}},{"facility":"Novo Nordisk Investigational Site","city":"Fort Myers","state":"Florida","zip":"33907","country":"United States","geoPoint":{"lat":26.62168,"lon":-81.84059}},{"facility":"Novo Nordisk Investigational Site","city":"Hollywood","state":"Florida","zip":"33023","country":"United States","geoPoint":{"lat":26.0112,"lon":-80.14949}},{"facility":"Novo Nordisk Investigational Site","city":"Jacksonville","state":"Florida","zip":"32205","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Novo Nordisk Investigational Site","city":"Jacksonville","state":"Florida","zip":"32216","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Novo 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Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12."},{"pmid":"19491536","type":"RESULT","citation":"McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998."},{"pmid":"19515413","type":"RESULT","citation":"Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, Zychma M, Blonde L; LEAD-6 Study Group. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet. 2009 Jul 4;374(9683):39-47. doi: 10.1016/S0140-6736(09)60659-0. Epub 2009 Jun 8."},{"pmid":"20332351","type":"RESULT","citation":"Buse JB, Sesti G, Schmidt WE, Montanya E, Chang CT, Xu Y, Blonde L, Rosenstock J; Liraglutide Effect Action in Diabetes-6 Study Group. Switching to once-daily liraglutide from twice-daily exenatide further improves glycemic control in patients with type 2 diabetes using oral agents. Diabetes Care. 2010 Jun;33(6):1300-3. doi: 10.2337/dc09-2260. Epub 2010 Mar 23."},{"pmid":"21388442","type":"RESULT","citation":"Schmidt WE, Christiansen JS, Hammer M, Zychma MJ, Buse JB. Patient-reported outcomes are superior in patients with Type 2 diabetes treated with liraglutide as compared with exenatide, when added to metformin, sulphonylurea or both: results from a randomized, open-label study. Diabet Med. 2011 Jun;28(6):715-23. doi: 10.1111/j.1464-5491.2011.03276.x."},{"pmid":"21450987","type":"RESULT","citation":"Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30."},{"pmid":"22018679","type":"RESULT","citation":"Valentine WJ, Palmer AJ, Lammert M, Langer J, Brandle M. Evaluating the long-term cost-effectiveness of liraglutide versus exenatide BID in patients with type 2 diabetes who fail to improve with oral antidiabetic agents. Clin Ther. 2011 Nov;33(11):1698-712. doi: 10.1016/j.clinthera.2011.09.022. Epub 2011 Oct 21."},{"pmid":"22055210","type":"RESULT","citation":"Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes >/=65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4."},{"pmid":"22193143","type":"RESULT","citation":"Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906."},{"pmid":"21883806","type":"RESULT","citation":"Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30."},{"pmid":"22862847","type":"RESULT","citation":"Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9."},{"pmid":"23010561","type":"RESULT","citation":"Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23."},{"pmid":"23186975","type":"RESULT","citation":"King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR."},{"pmid":"25504028","type":"RESULT","citation":"Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12."},{"pmid":"26936426","type":"RESULT","citation":"Davidson JA, Orsted DD, Campos C. Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials. Diabetes Obes Metab. 2016 Jul;18(7):725-8. doi: 10.1111/dom.12653. 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H0 was µ78 - µ0 = 0 against HA: µ78 - µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Paired t-test","paramType":"Mean","paramValue":"-0.98","ciPctValue":"95","ciLowerLimit":"-1.137","ciUpperLimit":"-0.823","dispersionType":"STANDARD_DEVIATION","dispersionValue":"1.119"},{"groupIds":["OG001"],"groupDescription":"The analysis was made with a paired t test within the exenatide→liraglutide group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0 = 0 against HA: µ78 - µ0 ≠ 0. 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52-78)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"229"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.24","spread":"0.33"},{"groupId":"OG001","value":"-2.87","spread":"0.33"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"ANCOVA model included treatment, country and previous treatment as fixed effects and baseline body weight as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. 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H0 was µ78 - µ26=0 against HA: µ78 - µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0793","statisticalMethod":"Paired t test","paramType":"Mean","paramValue":"-0.4","ciPctValue":"95","ciLowerLimit":"-0.86","ciUpperLimit":"0.05","dispersionType":"STANDARD_DEVIATION","dispersionValue":"3.24"},{"groupIds":["OG001"],"groupDescription":"A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0075","statisticalMethod":"Paired t test","paramType":"Mean","paramValue":"-0.7","ciPctValue":"95","ciLowerLimit":"-1.26","ciUpperLimit":"-0.20","dispersionType":"STANDARD_DEVIATION","dispersionValue":"3.67"}]},{"type":"SECONDARY","title":"Change in Body Weight at Week 78","description":"Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group)","populationDescription":"Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg","timeFrame":"week 0, week 78","groups":[{"id":"OG000","title":"Liraglutide -> Liraglutide -> Liraglutide","description":"Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"},{"id":"OG001","title":"Exenatide -> Liraglutide -> Liraglutide","description":"Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"199"},{"groupId":"OG001","value":"184"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.3","spread":"4.63"},{"groupId":"OG001","value":"-3.2","spread":"4.44"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. 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H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Paired t test","paramType":"Mean","paramValue":"-1.93","ciPctValue":"95","ciLowerLimit":"-2.457","ciUpperLimit":"-1.403","dispersionType":"STANDARD_DEVIATION","dispersionValue":"3.703"},{"groupIds":["OG001"],"groupDescription":"The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Paired t test","paramType":"Mean","paramValue":"-2.17","ciPctValue":"95","ciLowerLimit":"-2.731","ciUpperLimit":"-1.618","dispersionType":"STANDARD_DEVIATION","dispersionValue":"3.654"}]},{"type":"SECONDARY","title":"Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78","description":"Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.","populationDescription":"Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"week 0, week 78","groups":[{"id":"OG000","title":"Liraglutide -> Liraglutide -> Liraglutide","description":"Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"},{"id":"OG001","title":"Exenatide -> Liraglutide -> Liraglutide","description":"Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"191"},{"groupId":"OG001","value":"167"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.21","spread":"3.752"},{"groupId":"OG001","value":"-2.55","spread":"3.625"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Paired t test","paramType":"Mean","paramValue":"-2.21","ciPctValue":"95","ciLowerLimit":"-2.747","ciUpperLimit":"-1.676","dispersionType":"STANDARD_DEVIATION","dispersionValue":"3.752"},{"groupIds":["OG001"],"groupDescription":"The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Paired t test","paramType":"Mean","paramValue":"-2.55","ciPctValue":"95","ciLowerLimit":"-3.104","ciUpperLimit":"-1.997","dispersionType":"STANDARD_DEVIATION","dispersionValue":"3.625"}]},{"type":"SECONDARY","title":"Change in Beta-cell Function at Week 26","description":"Change in Beta-cell function from baseline (week 0) to 26 weeks (end of randomisation). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).\n\nBeta-cell function: HOMA-B (%) = 20∙fasting insulin\\[uU/mL\\] divided by (FPG mmol/L\\]-3.5).","populationDescription":"Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage point (%point)","timeFrame":"week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide -> Liraglutide -> Liraglutide","description":"Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"},{"id":"OG001","title":"Exenatide -> Liraglutide -> Liraglutide","description":"Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"214"},{"groupId":"OG001","value":"214"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"32.12","spread":"6.75"},{"groupId":"OG001","value":"2.74","spread":"6.75"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.0001","pValueComment":"There were no multiplicity concerns.","statisticalMethod":"ANCOVA","paramType":"Estimated treatment difference, LS Mean","paramValue":"29.37","ciPctValue":"95","ciLowerLimit":"16.81","ciUpperLimit":"41.93"}]},{"type":"SECONDARY","title":"Change in Beta-cell Function, Weeks 26-78","description":"Change in Beta-cell function from Week 26 (end of randomisation) to Week 78 (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).\n\nBeta-cell function: HOMA-B (%) = 20∙fasting insulin\\[uU/mL\\] divided by (FPG mmol/L\\]-3.5).","populationDescription":"Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage point (%point)","timeFrame":"week 26, week 78","groups":[{"id":"OG000","title":"Liraglutide -> Liraglutide -> Liraglutide","description":"Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"},{"id":"OG001","title":"Exenatide -> Liraglutide -> Liraglutide","description":"Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"198"},{"groupId":"OG001","value":"179"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-18.18","spread":"62.811"},{"groupId":"OG001","value":"2.29","spread":"52.997"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Paired t test","paramType":"Mean","paramValue":"-18.18","ciPctValue":"95","ciLowerLimit":"-26.988","ciUpperLimit":"-9.382","dispersionType":"STANDARD_DEVIATION","dispersionValue":"62.811"},{"groupIds":["OG001"],"groupDescription":"A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.5304","statisticalMethod":"Paired t test","paramType":"Mean","paramValue":"2.49","ciPctValue":"95","ciLowerLimit":"-5.327","ciUpperLimit":"10.307","dispersionType":"STANDARD_DEVIATION","dispersionValue":"52.997"}]},{"type":"SECONDARY","title":"Change in Beta-cell Function at Week 78","description":"Change in Beta-cell function from baseline (week 0) to 78 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).\n\nBeta-cell function: HOMA-B (%) = 20∙fasting insulin\\[uU/mL\\] divided by (FPG mmol/L\\]-3.5).","populationDescription":"Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage point (%point)","timeFrame":"week 0, week 78","groups":[{"id":"OG000","title":"Liraglutide -> Liraglutide -> Liraglutide","description":"Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"},{"id":"OG001","title":"Exenatide -> Liraglutide -> Liraglutide","description":"Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"189"},{"groupId":"OG001","value":"176"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"24.86","spread":"59.326"},{"groupId":"OG001","value":"11.13","spread":"87.145"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Paired t test","paramType":"Mean","paramValue":"24.86","ciPctValue":"95","ciLowerLimit":"16.348","ciUpperLimit":"33.374","dispersionType":"STANDARD_DEVIATION","dispersionValue":"59.326"},{"groupIds":["OG001"],"groupDescription":"The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0920","statisticalMethod":"Paired t test","paramType":"Mean","paramValue":"11.13","ciPctValue":"95","ciLowerLimit":"-1.835","ciUpperLimit":"24.093","dispersionType":"STANDARD_DEVIATION","dispersionValue":"87.145"}]},{"type":"SECONDARY","title":"Change in Total Cholesterol at Week 26","description":"Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation)","populationDescription":"Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide -> Liraglutide -> Liraglutide","description":"Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"},{"id":"OG001","title":"Exenatide -> Liraglutide -> Liraglutide","description":"Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"226"},{"groupId":"OG001","value":"220"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.20","spread":"0.07"},{"groupId":"OG001","value":"-0.09","spread":"0.07"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0946","pValueComment":"There were no multiplicity concerns.","statisticalMethod":"ANCOVA","paramType":"Estimated treatment difference, LS Mean","paramValue":"-0.11","ciPctValue":"95","ciLowerLimit":"-0.23","ciUpperLimit":"0.02"}]},{"type":"SECONDARY","title":"Change in Total Cholesterol, Weeks 26-78","description":"Change in total cholesterol (TC) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","populationDescription":"Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the trial products.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"week 26, week 78","groups":[{"id":"OG000","title":"Liraglutide -> Liraglutide -> Liraglutide","description":"Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"},{"id":"OG001","title":"Exenatide -> Liraglutide -> Liraglutide","description":"Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"199"},{"groupId":"OG001","value":"184"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.11","spread":"0.774"},{"groupId":"OG001","value":"0.12","spread":"0.804"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0513","statisticalMethod":"Paired t test","paramType":"Mean","paramValue":"0.11","ciPctValue":"95","ciLowerLimit":"-0.001","ciUpperLimit":"0.216","dispersionType":"STANDARD_DEVIATION","dispersionValue":"0.774"},{"groupIds":["OG001"],"groupDescription":"A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0513","statisticalMethod":"Paired t test","paramType":"Mean","paramValue":"0.12","ciPctValue":"95","ciLowerLimit":"-0.001","ciUpperLimit":"0.233","dispersionType":"STANDARD_DEVIATION","dispersionValue":"0.804"}]},{"type":"SECONDARY","title":"Change in Total Cholesterol at Week 78","description":"Change in total cholesterol (TC) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","populationDescription":"Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"week 0, week 78","groups":[{"id":"OG000","title":"Liraglutide -> Liraglutide -> Liraglutide","description":"Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"},{"id":"OG001","title":"Exenatide -> Liraglutide -> Liraglutide","description":"Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"198"},{"groupId":"OG001","value":"183"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.07","spread":"0.859"},{"groupId":"OG001","value":"0.09","spread":"0.890"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2764","statisticalMethod":"Paired t test","paramType":"Mean","paramValue":"-0.07","ciPctValue":"95","ciLowerLimit":"-0.187","ciUpperLimit":"0.054","dispersionType":"STANDARD_DEVIATION","dispersionValue":"0.859"},{"groupIds":["OG001"],"groupDescription":"The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1911","statisticalMethod":"Paired t test","paramType":"Mean","paramValue":"0.09","ciPctValue":"95","ciLowerLimit":"-0.043","ciUpperLimit":"0.216","dispersionType":"STANDARD_DEVIATION","dispersionValue":"0.890"}]},{"type":"SECONDARY","title":"Change in Low-density Lipoprotein-cholesterol at Week 26","description":"Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 26 weeks (end of randomisation)","populationDescription":"Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"week 0, week 26","groups":[{"id":"OG000","title":"Liraglutide -> Liraglutide -> Liraglutide","description":"Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"},{"id":"OG001","title":"Exenatide -> Liraglutide -> Liraglutide","description":"Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"219"},{"groupId":"OG001","value":"215"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.44","spread":"0.06"},{"groupId":"OG001","value":"-0.40","spread":"0.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.4412","pValueComment":"There were no multiplicity concerns.","statisticalMethod":"ANCOVA","paramType":"Estimated treatment difference, LS Mean","paramValue":"-0.04","ciPctValue":"95","ciLowerLimit":"-0.15","ciUpperLimit":"0.06"}]},{"type":"SECONDARY","title":"Change in Low-density Lipoprotein-cholesterol, Weeks 26-78","description":"Change in low-density lipoprotein-cholesterol (LDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","populationDescription":"Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"week 26, week 78","groups":[{"id":"OG000","title":"Liraglutide -> Liraglutide -> Liraglutide","description":"Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"},{"id":"OG001","title":"Exenatide -> Liraglutide -> Liraglutide","description":"Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"199"},{"groupId":"OG001","value":"180"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.03","spread":"0.606"},{"groupId":"OG001","value":"0.08","spread":"0.720"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.4746","statisticalMethod":"Paired t test","paramType":"Mean","paramValue":"0.03","ciPctValue":"95","ciLowerLimit":"-0.054","ciUpperLimit":"0.115","dispersionType":"STANDARD_DEVIATION","dispersionValue":"0.606"},{"groupIds":["OG001"],"groupDescription":"A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. 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Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0014","pValueComment":"There were no multiplicity concerns.","statisticalMethod":"ANCOVA","paramType":"Estimated treatment difference, LS Mean","paramValue":"-0.07","ciPctValue":"95","ciLowerLimit":"-0.11","ciUpperLimit":"-0.03"}]},{"type":"SECONDARY","title":"Change in Free Fatty Acid, Weeks 26-78","description":"Change in Free Fatty Acid (FFA) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\\> liraglutide group and the exenatide -\\> liraglutide group).","populationDescription":"Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"week 26, week 78","groups":[{"id":"OG000","title":"Liraglutide -> Liraglutide -> Liraglutide","description":"Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"},{"id":"OG001","title":"Exenatide -> Liraglutide -> Liraglutide","description":"Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"199"},{"groupId":"OG001","value":"182"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.06","spread":"0.269"},{"groupId":"OG001","value":"0.01","spread":"0.272"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. 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