Study S002222

Effect on Glycemic Control of Liraglutide in Combination With Rosiglitazone Plus Metformin Versus Rosiglitazone Plus Metformin in Subjects With Type 2 Diabetes

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT00333151
Acronym: LEAD-4
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 576
Start: 2006-05
Primary completion: 2007-08
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:liraglutide; DRUG:rosiglitazone; DRUG:metformin
Results posted: FALSE

Registered primary outcomes

HbA1c [after 26 weeks of treatment]

Linked records (15)

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.

Record	Title	Year	Design	Identifiers	Link basis
R0012795	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. Davidson JA, Diabetes, obesity & metabolism	2016	Systematic review	PMID 26936426 DOI	registry reference RESULT:26936426
R0023483	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. Jensen TM, Diabetes care	2015	Systematic review	PMID 25504028 DOI	registry reference RESULT:25504028
R0026607	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. Fonseca VA, Journal of diabetes and its complications	2014	Randomized trial	PMID 24561125 DOI	cites ClinicalTrials.gov:NCT00333151; registry reference DERIVED:24561125
R0016483	Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Niswender K, Diabetes, obesity & metabolism	2013	Randomized trial	PMID 22862847 DOI	registry reference RESULT:22862847
R0023531	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%. King AB, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists	2013	Other	PMID 23186975 DOI	registry reference RESULT:23186975
R0020069	A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Alves C, Diabetes research and clinical practice	2012	Systematic review	PMID 23010561 DOI	registry reference RESULT:23010561
R0022006	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. Zinman B, Diabetes, obesity & metabolism	2012	Systematic review	PMID 21883806 DOI	registry reference RESULT:21883806
R0017232	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. Buse JB, The Journal of clinical endocrinology and metabolism	2011	Other trial	PMID 21450987 DOI	cites ClinicalTrials.gov:NCT00333151; registry reference BACKGROUND:21450987
R0020188	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. Hegedüs L, The Journal of clinical endocrinology and metabolism	2011	Preclinical	PMID 21209033 DOI	cites ClinicalTrials.gov:NCT00333151; registry reference DERIVED:21209033
R0024125	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. Bode BW, The American journal of geriatric pharmacotherapy	2011	Randomized trial	PMID 22055210 DOI	registry reference RESULT:22055210
R0025876	Efficacy 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	2011	Systematic review	PMID 22193143 DOI	registry reference RESULT:22193143
R0017606	Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Zinman B, Diabetes care	2009	Randomized trial	PMID 19289857 DOI	cites ClinicalTrials.gov:NCT00333151; registry reference RESULT:19289857
R0022254	Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. McGill JB, Postgraduate medicine	2009	Randomized trial	PMID 19491536 DOI	registry reference RESULT:19491536
R0022352	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. Blonde L, Diabetes, obesity & metabolism	2009	Other trial	PMID 19878259 DOI	registry reference RESULT:19878259
R0026002	Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Sullivan SD, Cardiovascular diabetology	2009	Nonrandomized study	PMID 19245711 DOI	cites ClinicalTrials.gov:NCT00333151; registry reference RESULT:19245711