Study S000099

A Randomized, Open-label, Parallel-group, Multicenter Study to Determine the Efficacy and Long-term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus.

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: NCT00838916
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 779
Start: 2009-02
Primary completion: 2012-01
Lead sponsor: GlaxoSmithKline
Conditions: Diabetes Mellitus, Type 2
Interventions: BIOLOGICAL:albiglutide; DRUG:insulin glargine
Results posted: TRUE
Individual participant data sharing: YES

Registered primary outcomes

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 [Baseline and Week 52]

Linked records (4)

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
R0014141	Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy. Home PD, Diabetes research and clinical practice	2017	Randomized trial	PMID 28683300 DOI	cites ClinicalTrials.gov:NCT00838916; registry reference DERIVED:28683300
R0018591	Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Young MA, Postgraduate medicine	2014	Other trial	PMID 25387217 DOI	cites ClinicalTrials.gov:NCT00838916; registry reference DERIVED:25387217
R0025374	HARMONY 4: randomised clinical trial comparing once-weekly albiglutide and insulin glargine in patients with type 2 diabetes inadequately controlled with metformin with or without sulfonylurea. Weissman PN, Diabetologia	2014	Randomized trial	PMID 25208756 DOI	cites ClinicalTrials.gov:NCT00838916; registry reference DERIVED:25208756
R0025635	Effect of renal impairment on the pharmacokinetics, efficacy, and safety of albiglutide. Young MA, Postgraduate medicine	2014	Randomized trial	PMID 24918790 DOI	cites ClinicalTrials.gov:NCT00838916; registry reference DERIVED:24918790