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NCT01929863 · ClinicalTrials.gov registry record · Phase 2
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330672 in Type 2 Diabetes Patients Taking Metformin
A Phase 2 study of Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01929863: Completed Phase 2 study of Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline.
NCT01929863 is a Phase 2 study of Diabetes Mellitus, Type 2 that has completed, run by GlaxoSmithKline. The registered enrollment target is 16 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01929863, a Phase 2 study of Diabetes Mellitus, Type 2, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Metformin may have complex interactions in the gut and is generally first line therapy for type 2 diabetes mellitus (T2DM). It is important to understand whether there are significant pharmacokinetic or pharmacodynamic interactions when GSK2330672 is co-administered with metformin in subjects with T2DM. The purpose of this study is to investigate the safety and tolerability of GSK2330672 administered for 7 days to subjects with T2DM taking metformin. This will be a two-period crossover study; subjects will receive either GSK2330672 or placebo for 7 days in each period separated by a washout period of 13 to 15 days. All subjects will receive metformin throughout the study
Primary Outcome
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical o
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG GSK2330672
Study Locations (1)
Florida
- GSK Investigational Site - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-08-01 |
| Est. Completion | 2013-11-21 |
| Phase | Phase 2 |
What the finished NCT01929863 record still lists
NCT01929863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 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 (100% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01929863 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01929863 about?
NCT01929863 is a clinical study titled "Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330672 in Type 2 Diabetes Patients Taking Metformin". Metformin may have complex interactions in the gut and is generally first line therapy for type 2 diabetes mellitus (T2DM). It is important to understand whether there are significant pharmacokinetic or pharmacodynamic interactions when GSK2330672 is co-administered with metformin in subjects with T...
What is the current status of trial NCT01929863?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2013-08-01. Estimated completion is 2013-11-21.
What conditions does trial NCT01929863 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT01929863?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), GSK2330672 (DRUG).
Who is sponsoring clinical trial NCT01929863?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01929863 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01929863's enrollment target sits among peer trials
16 331st of 348 higher than 14 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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