LivingGLP1
Study S000029

A Randomized, Double-blind, Placebo and Active-Controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone in Subjects With Type 2 Diabetes Mellitus

ClinicalTrials.gov record

Registration

Registration
NCT00839527
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
DOUBLE
Status
COMPLETED
Enrollment
685
Start
2009-02
Primary completion
2012-01
Lead sponsor
GlaxoSmithKline
Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG:placebo to match albiglutide; BIOLOGICAL:albiglutide; DRUG:metformin; DRUG:glimepiride; DRUG:pioglitazone; DRUG:placebo to match pioglitazone
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 (3)

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
R0014141Three-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
2017Randomized trialPMID 28683300DOIcites ClinicalTrials.gov:NCT00839527; registry reference DERIVED:28683300
R0018591Clinical pharmacology of albiglutide, a GLP-1 receptor agonist.
Young MA, Postgraduate medicine
2014Other trialPMID 25387217DOIcites ClinicalTrials.gov:NCT00839527; registry reference DERIVED:25387217
R0025635Effect of renal impairment on the pharmacokinetics, efficacy, and safety of albiglutide.
Young MA, Postgraduate medicine
2014Randomized trialPMID 24918790DOIcites ClinicalTrials.gov:NCT00839527; registry reference DERIVED:24918790