CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 9,463 enrolled
Drug / intervention
Albiglutide 30 mg +2 morebiological
Likely dose
Albiglutide 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02465515
NCT02465515Phase 4Completed

A Long Term, Randomised, Double Blind, Placebo-controlled Study to Determine the Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Patients With Type 2 Diabetes Mellitus

GlaxoSmithKline·interventional·Posted Jun 8, 2015·Updated Mar 6, 2019

In Brief

A Phase 4 clinical trial evaluating Albiglutide 30 mg, Albiglutide 50 mg, and 1 other intervention for Diabetes Mellitus. Completed, enrolled 9,463 participants across 607 sites in 28 countries.

Detailed Summary

Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Italy, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 8, 2015
Enrollment StartJul 1, 2015
Primary CompletionFeb 20, 2018
Study CompletionMar 14, 2018
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.1 years ago

Interventions

Albiglutide 30 mgbiological

Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.

Albiglutide 50 mgbiological

Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.

Albiglutide matching placebobiological

Once weekly subcutaneous injection. Matched to 30 mg and 50 mg albiglutide.