Study S000852

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Two Dose Levels of Albiglutide Compared With Placebo in Subjects With Type 2 Diabetes Mellitus

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT00849017
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 309
Start: 2009-01
Primary completion: 2011-11
Lead sponsor: GlaxoSmithKline
Conditions: Diabetes Mellitus, Type 2
Interventions: BIOLOGICAL:albiglutide; BIOLOGICAL:albiglutide uptitration; BIOLOGICAL:placebo
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:NCT00849017; registry reference DERIVED:28683300
R0022386	Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Nauck MA, Diabetologia	2016	Randomized trial	PMID 26577795 DOI	cites ClinicalTrials.gov:NCT00849017; registry reference DERIVED:26577795
R0018591	Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Young MA, Postgraduate medicine	2014	Other trial	PMID 25387217 DOI	cites ClinicalTrials.gov:NCT00849017; registry reference DERIVED:25387217
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:NCT00849017; registry reference DERIVED:24918790