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NCT00519480 · ClinicalTrials.gov registry record · Phase 1
A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of >/ 2000mg of Metformin
A Phase 1 study of Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 4
- Study locations
NCT00519480: Completed Phase 1 study of Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline.
NCT00519480 is a Phase 1 study of Diabetes Mellitus, Type 2 that has completed, run by GlaxoSmithKline. The registered enrollment target is 50 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 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00519480, a Phase 1 study of Diabetes Mellitus, Type 2, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study will assess safety and tolerability of metformin plus GSK189075 in people with Type 2 Diabetes. About 48 people will participate in this study. Volunteers will not know if they are receiving GSK189075 or a placebo. Participation will last about 5 weeks including a run-in period of up to 2 weeks if necessary to increase metformin up to 2000mg daily, a 13-day treatment period, and a follow-up visit about 1 week after the treatment period. Volunteers will remain in the research clinic beginning 2 days before they receive the first dose of GSK189075 until after the morning dose on the fourth day and from the afternoon of the 12th day of dosing until the morning after the last dose. They will have clinic visits on dosing Days 6, 8, and 10. Volunteers will be given equipment and instructions for measuring their blood sugar at home and will be asked to keep a study diary. Blood pressure, heart rate, laboratory tests on blood and urine, physical examinations, reports of drug side effects and ECGs will be obtained during the clinic visits to assess safety.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG GSK189075
Study Locations (4)
Other
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Berlin
Florida
- GSK Investigational Site - Miami
Texas
- GSK Investigational Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2007-09-11 |
| Est. Completion | 2008-04-01 |
| Phase | Phase 1 |
What the finished NCT00519480 record still lists
NCT00519480 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 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 Placebo is the first listed.
NCT00519480 reports a single indexed study location in Other, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT00519480 about?
NCT00519480 is a clinical study titled "A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of >/ 2000mg of Metformin". This study will assess safety and tolerability of metformin plus GSK189075 in people with Type 2 Diabetes. About 48 people will participate in this study. Volunteers will not know if they are receiving GSK189075 or a placebo. Participation will last about 5 weeks including a run-in period of up to 2...
What is the current status of trial NCT00519480?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2007-09-11. Estimated completion is 2008-04-01.
What conditions does trial NCT00519480 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT00519480?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), GSK189075 (DRUG).
Who is sponsoring clinical trial NCT00519480?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00519480 being conducted?
This trial has 4 study locations across Florida, Texas. 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 NCT00519480's enrollment target sits among peer trials
50 259th of 348 higher than 86 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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