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NCT01475734 · ClinicalTrials.gov registry record · Phase 2
Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes
A Phase 2 study of Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT01475734: Completed Phase 2 study of Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline.
NCT01475734 is a Phase 2 study of Diabetes Mellitus, Type 2 that has completed, run by GlaxoSmithKline. The registered enrollment target is 44 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01475734, a Phase 2 study of Diabetes Mellitus, Type 2, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a stepped glucose clamp study designed to investigate the effect of treatment with albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be given prior to a stepped hyper- and hypoglycemic clamp. The goal of this study is to demonstrate that albiglutide increases insulin secretion and decreases glucagon levels in a glucose-dependent manner.
Primary Outcome
Plasma glucagon levels were measured for the estimation of glucagon secretion during the hypoglycemic periods. Glucagon response was measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour \[hr\], 1hr, 1 hr 15 minutes \[min\]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of va
Conditions Studied
Interventions
- BIOLOGICAL placebo
- BIOLOGICAL albiglutide
Study Locations (1)
California
- GSK Investigational Site - Chula Vista
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
What the finished NCT01475734 record still lists
NCT01475734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01475734 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01475734 about?
NCT01475734 is a clinical study titled "Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes". This is a stepped glucose clamp study designed to investigate the effect of treatment with albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be given prior to a stepped hyper- and...
What is the current status of trial NCT01475734?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2011-12. Estimated completion is 2012-07.
What conditions does trial NCT01475734 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT01475734?
The interventions under investigation include: placebo (BIOLOGICAL), albiglutide (BIOLOGICAL).
Who is sponsoring clinical trial NCT01475734?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01475734 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01475734's enrollment target sits among peer trials
44 276th of 348 higher than 73 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 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.
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