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NCT00518115 · ClinicalTrials.gov registry record · Phase 2
Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 361
- Enrollment target
NCT00518115: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00518115 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 361 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (171% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00518115, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 361 participants
- Enrollment target
Study Summary
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.
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 Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 16 minus the value at Baseline. Based on ANCOVA: Change = treatment + Baseline HbA1c + prior therapy + gender + region. The last observation carried forward (LOCF) method was used to impute missing
Interventions
- DRUG Albiglutide (GSK716155) or exenatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 361 participants |
| Start Date | 2007-04 |
| Est. Completion | 2008-05 |
| Phase | Phase 2 |
What the finished NCT00518115 record still lists
NCT00518115 is an interventional study that assigns participants to a tested intervention. The registered 361 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (171% higher).
The record links to 0 conditions, and to 1 intervention - of which Albiglutide (GSK716155) or exenatide is the first listed.
NCT00518115 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00518115 about?
NCT00518115 is a clinical study titled "Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only". 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 (...
What is the current status of trial NCT00518115?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 361 participants. The study started on 2007-04. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00518115?
The interventions under investigation include: Albiglutide (GSK716155) or exenatide (DRUG).
Who is sponsoring clinical trial NCT00518115?
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 NCT00518115's enrollment target sits among peer trials
361 123rd of 2000 higher than 1,878 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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