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NCT01357889 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics/Pharmacodynamics of Albiglutide
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 283
- Enrollment target
NCT01357889: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01357889 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 283 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (113% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01357889, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 283 participants
- Enrollment target
Study Summary
The first part of the study includes a single dose treatment period to evaluate the pharmacokinetic bioequivalence of a subcutaneous injection of albiglutide from process 2 drug substance compared with process 3 drug substance. The second part of the treatment period will evaluate additional pharmacokinetic and pharmacodynamic parameters and safety and tolerability of repeat doses of albiglutide given weekly for 12 weeks from process 2 drug substance compared with process 3 drug substance. Subjects with type 2 diabetes whose glycemia is inadequately controlled on their current regimen of diet and exercise or stable dose of metformin will be recruited into the study.
Primary Outcome
To assess the bioequivalence of the two formulations of albiglutide, an analysis of variance (ANOVA) model with treatment as a fixed effect was applied to the natural-log-transformed parameter AUC(0-inf) estimated from the BE Phase. AUC is a measure of how much albiglutide is in the blood at certain time points. The Process 2 treatment group (albiglutide derived from process 2) was the reference group and was compared with the Process 3 treatment group (albiglutide derived from process 3) as the
Interventions
- BIOLOGICAL albiglutide (GSK716155)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
What the finished NCT01357889 record still lists
NCT01357889 is an interventional study that assigns participants to a tested intervention. The registered 283 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 (113% higher).
The record links to 0 conditions, and to 1 intervention - of which albiglutide (GSK716155) is the first listed.
NCT01357889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01357889 about?
NCT01357889 is a clinical study titled "Pharmacokinetics/Pharmacodynamics of Albiglutide". The first part of the study includes a single dose treatment period to evaluate the pharmacokinetic bioequivalence of a subcutaneous injection of albiglutide from process 2 drug substance compared with process 3 drug substance. The second part of the treatment period will evaluate additional pharmac...
What is the current status of trial NCT01357889?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 283 participants. The study started on 2011-07. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01357889?
The interventions under investigation include: albiglutide (GSK716155) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01357889?
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 NCT01357889's enrollment target sits among peer trials
283 195th of 2000 higher than 1,806 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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