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NCT01128621 · ClinicalTrials.gov registry record · Phase 2
A Study in Type 2 Diabetic Subjects on Stable Metformin Therapy to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Co-administering Single and Multiple Oral Doses of GSK1292263
A Phase 2 study of Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 2
- Study locations
NCT01128621: Completed Phase 2 study of Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline.
NCT01128621 is a Phase 2 study of Diabetes Mellitus, Type 2 that has completed, run by GlaxoSmithKline. The registered enrollment target is 66 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 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01128621, a Phase 2 study of Diabetes Mellitus, Type 2, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 2
- Study locations
Study Summary
A study in type 2 diabetic subjects on stable metformin therapy to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of co-administering single and multiple oral doses of GSK1292263
Primary Outcome
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose
Conditions Studied
Interventions
- DRUG Sitagliptin
- DRUG GSK1292263
- DRUG GSK1292263 matching placebo
Study Locations (2)
California
- GSK Investigational Site - Chula Vista
Florida
- GSK Investigational Site - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2009-11-23 |
| Est. Completion | 2010-04-12 |
| Phase | Phase 2 |
What the finished NCT01128621 record still lists
NCT01128621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 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 3 interventions - of which Sitagliptin is the first listed.
NCT01128621 reports a single indexed study location in California, Florida.
Frequently Asked Questions
What is clinical trial NCT01128621 about?
NCT01128621 is a clinical study titled "A Study in Type 2 Diabetic Subjects on Stable Metformin Therapy to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Co-administering Single and Multiple Oral Doses of GSK1292263". A study in type 2 diabetic subjects on stable metformin therapy to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of co-administering single and multiple oral doses of GSK1292263
What is the current status of trial NCT01128621?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2009-11-23. Estimated completion is 2010-04-12.
What conditions does trial NCT01128621 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT01128621?
The interventions under investigation include: Sitagliptin (DRUG), GSK1292263 (DRUG), GSK1292263 matching placebo (DRUG).
Who is sponsoring clinical trial NCT01128621?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01128621 being conducted?
This trial has 2 study locations across California, Florida. 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 NCT01128621's enrollment target sits among peer trials
66 231st of 348 higher than 115 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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