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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: Clinical Trial Phase 4 study, sponsored by GlaxoSmithKline.
NCT02793154 is a Phase 4 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The effect of exenatide on gastric myoelectrical activity was assessed by electrogastrogram (EGG) using water load test (WLT). EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Indivi
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 |
Why NCT02793154 stopped before completion
NCT02793154 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Exenatide is the first listed.
NCT02793154 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02793154's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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