{"protocolSection":{"identificationModule":{"nctId":"NCT00294723","nctIdAliases":["NCT00853359"],"orgStudyIdInfo":{"id":"NN2211-1573"},"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c","officialTitle":"Liraglutide Effect and Action in Diabetes (LEAD-3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes","acronym":"LEAD-3"},"statusModule":{"statusVerifiedDate":"2017-01","overallStatus":"TERMINATED","whyStopped":"The trial was terminated at week 195 due to an insufficient number of subjects remaining to obtain reasonable statistical power","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-02"},"primaryCompletionDateStruct":{"date":"2008-11","type":"ACTUAL"},"completionDateStruct":{"date":"2008-11","type":"ACTUAL"},"studyFirstSubmitDate":"2006-02-20","studyFirstSubmitQcDate":"2006-02-20","studyFirstPostDateStruct":{"date":"2006-02-22","type":"ESTIMATED"},"resultsFirstSubmitDate":"2010-02-23","resultsFirstSubmitQcDate":"2010-02-23","resultsFirstPostDateStruct":{"date":"2010-03-12","type":"ESTIMATED"},"dispFirstSubmitDate":"2009-11-09","dispFirstSubmitQcDate":"2009-11-09","dispFirstPostDateStruct":{"date":"2009-11-11","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-01-24","lastUpdatePostDateStruct":{"date":"2017-03-07","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is conducted in North America (the United States of America (USA) and Mexico).\n\nThe trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years)."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":746,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Lira 1.8","type":"EXPERIMENTAL","description":"Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195).","interventionNames":["Drug: liraglutide","Drug: placebo"]},{"label":"Lira 1.2","type":"EXPERIMENTAL","description":"Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195).","interventionNames":["Drug: liraglutide","Drug: placebo"]},{"label":"Glimepiride - 1","type":"ACTIVE_COMPARATOR","description":"Glimepiride 8 mg once daily + liraglutide placebo 200 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).","interventionNames":["Drug: glimepiride","Drug: placebo"]},{"label":"Glimepiride - 2","type":"ACTIVE_COMPARATOR","description":"Glimepiride 8 mg once daily + liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).","interventionNames":["Drug: glimepiride","Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"liraglutide","description":"1.8 mg for s.c. (under the skin) injection","armGroupLabels":["Lira 1.8"]},{"type":"DRUG","name":"glimepiride","description":"8 mg capsule","armGroupLabels":["Glimepiride - 1","Glimepiride - 2"]},{"type":"DRUG","name":"liraglutide","description":"1.2 mg for s.c. (under the skin) injection","armGroupLabels":["Lira 1.2"]},{"type":"DRUG","name":"placebo","description":"Glimepiride placebo, 8mg capsule","armGroupLabels":["Lira 1.2","Lira 1.8"]},{"type":"DRUG","name":"placebo","description":"Liraglutide placebo, 200 mcl","armGroupLabels":["Glimepiride - 1"]},{"type":"DRUG","name":"placebo","description":"Liraglutide placebo, 300 mcl","armGroupLabels":["Glimepiride - 2"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52","description":"Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period)","timeFrame":"week 0, week 52"},{"measure":"Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104","description":"Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension)","timeFrame":"week 0, week 104"},{"measure":"Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156","description":"Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks","timeFrame":"week 0, week 156"}],"secondaryOutcomes":[{"measure":"Change in Body Weight at Week 52","description":"Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period)","timeFrame":"week 0, week 52"},{"measure":"Change in Body Weight at Week 104","description":"Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension)","timeFrame":"week 0, week 104"},{"measure":"Change in Body Weight at Week 156","description":"Change in body weight from baseline (week 0) to 156 weeks","timeFrame":"week 0, week 156"},{"measure":"Change in Fasting Plasma Glucose at Week 52","description":"Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period)","timeFrame":"week 0, week 52"},{"measure":"Change in Fasting Plasma Glucose at Week 104","description":"Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension)","timeFrame":"week 0, week 104"},{"measure":"Change in Fasting Plasma Glucose at Week 156","description":"Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks","timeFrame":"week 0, week 156"},{"measure":"Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52","description":"Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.","timeFrame":"week 0, week 52"},{"measure":"Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104","description":"Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.","timeFrame":"week 0, week 104"},{"measure":"Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156","description":"Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 156 weeks. The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.","timeFrame":"week 0, week 156"},{"measure":"Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52","description":"Change in mean prandial increments of plasma glucose from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.","timeFrame":"week 0, week 52"},{"measure":"Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104","description":"Change in mean prandial increments of plasma glucose from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.","timeFrame":"week 0, week 104"},{"measure":"Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156","description":"Change in mean prandial increments (incr.) of plasma glucose from baseline (week 0) to 156 weeks. The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.","timeFrame":"week 0, week 156"},{"measure":"Hypoglycaemic Episodes","description":"Total number of hypoglycaemic episodes occuring from baseline (week 0) to 104 weeks (end of the 52-week extension). 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 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.","timeFrame":"weeks 0-104"},{"measure":"Hypoglycaemic Episodes","description":"Total number of hypoglycaemic episodes occuring from week 104 to end of trial (week 195). 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 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.","timeFrame":"weeks 104-195"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Type 2 diabetes\n* TTreatment with diet/exercise or with not more than half maximal dose of oral anti-diabetic drugs alone for at least 2 months\n* Diet/exercise treated subjects with HbA1c between 7.0% and 11%, inclusive\n* OAD (oral anti-diabetic drug) treated subjects with HbA1c between 7.0% and 10%, inclusive\n* Body Mass Index (BMI) less than or equal to 45 kg/m\\^2\n\nExclusion Criteria:\n\n* Treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness\n* Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound)\n* Any serious medical condition","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"80 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Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009 Feb 7;373(9662):473-81. doi: 10.1016/S0140-6736(08)61246-5. Epub 2008 Sep 24."},{"pmid":"19245711","type":"RESULT","citation":"Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. 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":"19878259","type":"RESULT","citation":"Blonde L, Russell-Jones D. The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies. Diabetes Obes Metab. 2009 Dec;11 Suppl 3:26-34. doi: 10.1111/j.1463-1326.2009.01075.x."},{"pmid":"19930006","type":"RESULT","citation":"Jendle J, Nauck MA, Matthews DR, Frid A, Hermansen K, During M, Zdravkovic M, Strauss BJ, Garber AJ; LEAD-2 and LEAD-3 Study Groups. Weight loss with liraglutide, a once-daily human glucagon-like peptide-1 analogue for type 2 diabetes treatment as monotherapy or added to metformin, is primarily as a result of a reduction in fat tissue. Diabetes Obes Metab. 2009 Dec;11(12):1163-72. doi: 10.1111/j.1463-1326.2009.01158.x."},{"pmid":"20590735","type":"RESULT","citation":"Bode BW, Testa MA, Magwire M, Hale PM, Hammer M, Blonde L, Garber A; LEAD-3 Study Group. Patient-reported outcomes following treatment with the human GLP-1 analogue liraglutide or glimepiride in monotherapy: results from a randomized controlled trial in patients with type 2 diabetes. Diabetes Obes Metab. 2010 Jul;12(7):604-12. doi: 10.1111/j.1463-1326.2010.01196.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":"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":"22174428","type":"RESULT","citation":"Ingwersen SH, Khurana M, Madabushi R, Watson E, Jonker DM, Le Thi TD, Jacobsen LV, Tornoe CW. Dosing rationale for liraglutide in type 2 diabetes mellitus: a pharmacometric assessment. J Clin Pharmacol. 2012 Dec;52(12):1815-23. doi: 10.1177/0091270011430504. Epub 2011 Dec 15."},{"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":"26574791","type":"RESULT","citation":"Gilbert MP, Marre M, Holst JJ, Garber A, Baeres FM, Thomsen H, Pratley RE. COMPARISON OF THE LONG-TERM EFFECTS OF LIRAGLUTIDE AND GLIMEPIRIDE MONOTHERAPY ON BONE MINERAL DENSITY IN PATIENTS WITH TYPE 2 DIABETES. Endocr Pract. 2016 Apr;22(4):406-11. doi: 10.4158/EP15758.OR. Epub 2015 Nov 17."},{"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. Epub 2016 Apr 28."},{"pmid":"24561125","type":"DERIVED","citation":"Fonseca VA, Devries JH, Henry RR, Donsmark M, Thomsen HF, Plutzky J. Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials. J Diabetes Complications. 2014 May-Jun;28(3):399-405. doi: 10.1016/j.jdiacomp.2014.01.009. Epub 2014 Jan 21."},{"pmid":"21209033","type":"DERIVED","citation":"Hegedus L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Subjects with type 2 diabetes treated with diet/exercise or OAD (Oral Anti-Diabetic Drug) monotherapy for at least 2 months were eligible. 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