Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only

NCT00518115 · Completed

Last updated 2026-05-28

This clinical trial is testing how a new treatment affects blood sugar levels in adults with type 2 diabetes who are not currently taking diabetes medication or are only taking metformin.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 361 people

Who can join Ages 18–75 · all sexes

Timeline Started 2007-04 · est. completion 2008-05

Where 163 sites · Chile, Dominican Republic, United States

What this study is testing ClinicalTrials.gov NCT00518115 ↗

Description as written by the study sponsor.

This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only. This study will investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will measure the levels of Albiglutide (GSK716155) in the bloodstream when it is given for 16 weeks. As a comparison, some subjects will receive exenatide instead of Albiglutide (GSK716155). The study will involve weekly visits for 17 weeks,and less frequent follow-up visits for an additional 10 weeks. Assessments include repeat blood sampling and monitoring of any side effects.

Treatments tested

Albiglutide (GSK716155) or exenatide Drug

Albiglutide weekly subcutaneous injection or exenatide twice daily injection

Main thing measured	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
Sponsor	GlaxoSmithKline
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00518115 ↗