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NCT00976391 · ClinicalTrials.gov registry record · Phase 3
A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 586
- Enrollment target
NCT00976391: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00976391 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 586 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00976391, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 586 participants
- Enrollment target
Study Summary
This study will examine the safety and efficacy of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes.
Primary Outcome
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 26 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (\<65 years vers
Interventions
- BIOLOGICAL albiglutide + insulin glargine
- DRUG insulin glargine + preprandial lispro insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 586 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT00976391 record still lists
NCT00976391 is an interventional study that assigns participants to a tested intervention. The registered 586 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 2 interventions - of which albiglutide + insulin glargine is the first listed.
NCT00976391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00976391 about?
NCT00976391 is a clinical study titled "A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine". This study will examine the safety and efficacy of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes.
What is the current status of trial NCT00976391?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 586 participants. The study started on 2009-09. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00976391?
The interventions under investigation include: albiglutide + insulin glargine (BIOLOGICAL), insulin glargine + preprandial lispro insulin (DRUG).
Who is sponsoring clinical trial NCT00976391?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00976391's enrollment target sits among peer trials
586 647th of 2000 higher than 1,350 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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