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NCT01098539 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 507
- Enrollment target
NCT01098539: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01098539 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 507 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01098539, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 507 participants
- Enrollment target
Study Summary
This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.
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 26 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and ag
Interventions
- BIOLOGICAL albiglutide
- DRUG sitagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 507 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT01098539 record still lists
NCT01098539 is an interventional study that assigns participants to a tested intervention. The registered 507 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 (34% lower).
The record links to 0 conditions, and to 2 interventions - of which albiglutide is the first listed.
NCT01098539 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01098539 about?
NCT01098539 is a clinical study titled "A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.". This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their curr...
What is the current status of trial NCT01098539?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 507 participants. The study started on 2010-05. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01098539?
The interventions under investigation include: albiglutide (BIOLOGICAL), sitagliptin (DRUG).
Who is sponsoring clinical trial NCT01098539?
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 NCT01098539's enrollment target sits among peer trials
507 739th of 2000 higher than 1,260 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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