LivingGLP1
Study S002098

Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.

Included trial: extracted dataClinicalTrials.gov record

Registration

Registration
NCT00331851
Acronym
LEAD-5
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
DOUBLE
Status
COMPLETED
Enrollment
584
Start
2006-05
Primary completion
2007-04
Lead sponsor
Novo Nordisk A/S
Conditions
Diabetes; Diabetes Mellitus, Type 2
Interventions
DRUG:liraglutide; DRUG:insulin glargine; DRUG:metformin; DRUG:glimepiride
Results posted
FALSE

Registered primary outcomes

  • HbA1c [after 26 weeks of treatment]

Linked records (14)

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
R0012750Is insulin the most effective injectable antihyperglycaemic therapy?
Buse JB, Diabetes, obesity & metabolism
2015Randomized trialPMID 25323312DOIregistry reference RESULT:25323312
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:NCT00331851; 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
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
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 21450987DOIcites ClinicalTrials.gov:NCT00331851; registry reference RESULT:21450987
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
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
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:NCT00331851; registry reference RESULT:19245711
R0027336Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial.
Russell-Jones D, Diabetologia
2009Randomized trialPMID 19688338DOIcites ClinicalTrials.gov:NCT00331851; registry reference RESULT:19688338