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NCT02793154 · ClinicalTrials.gov registry record · Phase 4
An Exploratory Study on the Effects of Repeat Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Type 2 Diabetes Mellitus Subjects
A Phase 4 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT02793154 is a Phase 4 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 4 participants.
The verdict
NCT02793154, a Phase 4 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the effect of albiglutide and exenatide on gastric myoelectrical activity (GMA), gastric emptying (GE) and nausea (as measured by visual analogue scale \[VAS\]) in subjects with type 2 diabetes mellitus (T2DM). The study is divided in two parts. Part A will characterize the GMA, GE and nausea response to exenatide and confirm exenatide as a positive control for Part B. Part B will compare the effects of albiglutide and exenatide on GMA, GE and nausea. Part A is a single arm, open-label design and all subjects will receive 10 microgram (mcg) subcutaneous exenatide twice daily for 5 days. This part will comprise 3 study periods: a 3-week screening/wash-out, 5-day treatment, and follow-up (within 7 days after the last dose of exenatide). The total duration of a subject's participation in Part A will be approximately 5 weeks. Once Part A is complete, data will be reviewed and a decision to progress to Part B will be made. In Part B, subjects will be randomized 1:1 to receive either albiglutide (starting dose of 30 milligrams \[mg\] once weekly for 4 weeks, followed by 50 mg once weekly for 4 weeks) or exenatide (starting dose of 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 4 weeks). The total duration of a subject's participation in the study will be approximately 15 weeks.
Interventions
- DRUG Exenatide
- DRUG Albiglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2016-09-26 |
| Est. Completion | 2017-03-16 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02793154
The ClinicalTrials.gov registry entry for NCT02793154 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 4 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 2 interventions - of which Exenatide is the first listed.
NCT02793154 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02793154 about?
NCT02793154 is a clinical study titled "An Exploratory Study on the Effects of Repeat Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Type 2 Diabetes Mellitus Subjects". The primary objective of this study is to compare the effect of albiglutide and exenatide on gastric myoelectrical activity (GMA), gastric emptying (GE) and nausea (as measured by visual analogue scale \[VAS\]) in subjects with type 2 diabetes mellitus (T2DM). The study is divided in two parts. Part...
What is the current status of trial NCT02793154?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2016-09-26. Estimated completion is 2017-03-16.
What interventions are being tested in trial NCT02793154?
The interventions under investigation include: Exenatide (DRUG), Albiglutide (DRUG).
Who is sponsoring clinical trial NCT02793154?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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