Study S001242

A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin

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: NCT00734474
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2; PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 1202
Start: 2008-08
Primary completion: 2011-06
Lead sponsor: Eli Lilly and Company
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:LY2189265; DRUG:Sitagliptin; DRUG:Placebo solution; DRUG:Placebo tablet; DRUG:Metformin
Results posted: TRUE
Secondary identifiers: OTHER:H9X-MC-GBCF; REGISTRY:CTRI/2009/091/000969

Registered primary outcomes

Glycosylated Hemoglobin (HbA1c) Change From Baseline [Baseline, 52 weeks]

Linked records (7)

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
R0008191	Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Ferdinand KC, Cardiovascular diabetology	2023	Systematic review	PMID 36894938 DOI	cites ClinicalTrials.gov:NCT00734474; registry reference DERIVED:36894938
R0006767	No calcitonin change in a person taking dulaglutide diagnosed with pre-existing medullary thyroid cancer. Sherman SI, Diabetic medicine : a journal of the British Diabetic Association	2018	Case report	PMID 28755389 DOI	cites ClinicalTrials.gov:NCT00734474; registry reference DERIVED:28755389
R0020285	Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Yu M, Diabetes, obesity & metabolism	2016	Other trial	PMID 26691396 DOI	cites ClinicalTrials.gov:NCT00734474; registry reference DERIVED:26691396
R0025090	Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years. Boustani MA, Diabetes, obesity & metabolism	2016	Other trial	PMID 27161178 DOI	cites ClinicalTrials.gov:NCT00734474; registry reference DERIVED:27161178
R0025391	Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Weinstock RS, Diabetes, obesity & metabolism	2015	Randomized trial	PMID 25912221 DOI	cites ClinicalTrials.gov:NCT00734474; registry reference DERIVED:25912221
R0022904	Dose-finding results in an adaptive, seamless, randomized trial of once-weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD-5). Skrivanek Z, Diabetes, obesity & metabolism	2014	Randomized trial	PMID 24762094 DOI	cites ClinicalTrials.gov:NCT00734474; registry reference DERIVED:24762094
R0028284	Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study. Spencer K, Journal of diabetes science and technology	2012	Other trial	PMID 23294774 DOI	cites ClinicalTrials.gov:NCT00734474; registry reference DERIVED:23294774