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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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 283 participants.
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.
Interventions
- BIOLOGICAL albiglutide (GSK716155)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01357889
The ClinicalTrials.gov registry entry for NCT01357889 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 283 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which albiglutide (GSK716155) is the first listed.
NCT01357889 reports 0 study locations.
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.
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