LivingGLP1
Study S001502

Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes

Included trial: extracted dataClinicalTrials.gov record

Registration

Registration
NCT00318461
Acronym
LEAD-2
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
DOUBLE
Status
COMPLETED
Enrollment
1091
Start
2006-05
Primary completion
2007-05
Lead sponsor
Novo Nordisk A/S
Conditions
Diabetes; Diabetes Mellitus, Type 2
Interventions
DRUG:liraglutide; DRUG:metformin; DRUG:glimepiride; DRUG:placebo
Results posted
TRUE

Registered primary outcomes

  • Change in Glycosylated A1c (HbA1c) at Week 26 [week 0, week 26]
  • Change in Glycosylated A1c (HbA1c) at Week 104 [week 0, week 104]

Linked records (18)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0023483Is 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.
Jensen TM, Diabetes care
2015Systematic reviewPMID 25504028DOIregistry reference RESULT:25504028
R0026607Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials.
Fonseca VA, Journal of diabetes and its complications
2014Randomized trialPMID 24561125DOIcites ClinicalTrials.gov:NCT00318461; registry reference DERIVED:24561125
R0016483Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme.
Niswender K, Diabetes, obesity & metabolism
2013Randomized trialPMID 22862847DOIregistry reference RESULT:22862847
R0023531Liraglutide 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%.
King AB, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
2013OtherPMID 23186975DOIregistry reference RESULT:23186975
R0026731Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study.
Nauck M, Diabetes, obesity & metabolism
2013Randomized trialPMID 22985213DOIregistry reference RESULT:22985213
R0020069A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer.
Alves C, Diabetes research and clinical practice
2012Systematic reviewPMID 23010561DOIregistry reference RESULT:23010561
R0022006Achieving 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.
Zinman B, Diabetes, obesity & metabolism
2012Systematic reviewPMID 21883806DOIregistry reference RESULT:21883806
R0026951Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus.
Davies MJ, Diabetic medicine : a journal of the British Diabetic Association
2012Other trialPMID 21883438DOIregistry reference RESULT:21883438
R0017232Liraglutide 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.
Buse JB, The Journal of clinical endocrinology and metabolism
2011Other trialPMID 21450987DOIregistry reference RESULT:21450987
R0020188GLP-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.
Hegedüs L, The Journal of clinical endocrinology and metabolism
2011PreclinicalPMID 21209033DOIcites ClinicalTrials.gov:NCT00318461; registry reference DERIVED:21209033
R0024125Comparison 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.
Bode BW, The American journal of geriatric pharmacotherapy
2011Randomized trialPMID 22055210DOIregistry reference RESULT:22055210
R0025876Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program.
Henry RR, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
2011Systematic reviewPMID 22193143DOIregistry reference RESULT:22193143
R0019848Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study.
Nauck M, Diabetes care
2009Randomized trialPMID 18931095DOIcites ClinicalTrials.gov:NCT00318461; registry reference RESULT:18931095
R0022254Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies.
McGill JB, Postgraduate medicine
2009Randomized trialPMID 19491536DOIregistry reference RESULT:19491536
R0022352The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies.
Blonde L, Diabetes, obesity & metabolism
2009Other trialPMID 19878259DOIregistry reference RESULT:19878259
R0023385Weight 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.
Jendle J, Diabetes, obesity & metabolism
2009Randomized trialPMID 19930006DOIregistry reference RESULT:19930006
R0026002Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone.
Sullivan SD, Cardiovascular diabetology
2009Nonrandomized studyPMID 19245711DOIcites ClinicalTrials.gov:NCT00318461; registry reference RESULT:19245711
R0027548Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits.
Nauck M, Postgraduate medicine
2009Randomized trialPMID 19491535DOIcites ClinicalTrials.gov:NCT00318461; registry reference RESULT:19491535