LivingGLP1
Study S002230

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

Included trial: extracted dataClinicalTrials.gov record

Registration

Registration
NCT00518882
Acronym
LEAD-6
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
NONE
Status
COMPLETED
Enrollment
467
Start
2007-08
Primary completion
2008-04
Lead sponsor
Novo Nordisk A/S
Conditions
Diabetes; Diabetes Mellitus, Type 2
Interventions
DRUG:liraglutide; DRUG:exenatide
Results posted
TRUE
Secondary identifiers
EUDRACT_NUMBER:2006-006092-21

Registered primary outcomes

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

Linked records (16)

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
R0012795Efficacy 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.
Davidson JA, Diabetes, obesity & metabolism
2016Systematic reviewPMID 26936426DOIregistry reference RESULT:26936426
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:NCT00518882; 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:NCT00518882; registry reference RESULT:21450987
R0022076Evaluating the long-term cost-effectiveness of liraglutide versus exenatide BID in patients with type 2 diabetes who fail to improve with oral antidiabetic agents.
Valentine WJ, Clinical therapeutics
2011Nonrandomized studyPMID 22018679DOIcites ClinicalTrials.gov:NCT00518882; registry reference RESULT:22018679
R0023843Patient-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.
Schmidt WE, Diabetic medicine : a journal of the British Diabetic Association
2011Randomized trialPMID 21388442DOIcites ClinicalTrials.gov:NCT00518882; registry reference RESULT:21388442
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
R0024085Switching to once-daily liraglutide from twice-daily exenatide further improves glycemic control in patients with type 2 diabetes using oral agents.
Buse JB, Diabetes care
2010Randomized trialPMID 20332351DOIcites ClinicalTrials.gov:NCT00518882; registry reference RESULT:20332351
R0020382Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6).
Buse JB, Lancet (London, England)
2009Randomized trialPMID 19515413DOIcites ClinicalTrials.gov:NCT00518882; registry reference RESULT:19515413
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
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:NCT00518882; registry reference RESULT:19245711