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NCT00316758 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 259
- Enrollment target
NCT00316758: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT00316758 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 259 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00316758, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 259 participants
- Enrollment target
Study Summary
This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Interventions
- DRUG Metformin
- DRUG GK Activator (2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2006-02 |
| Est. Completion | 2007-10 |
| Phase | Phase 2 |
What the finished NCT00316758 record still lists
NCT00316758 is an interventional study that assigns participants to a tested intervention. The registered 259 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% higher).
The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.
NCT00316758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00316758 about?
NCT00316758 is a clinical study titled "A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.". This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) mono...
What is the current status of trial NCT00316758?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 259 participants. The study started on 2006-02. Estimated completion is 2007-10.
What interventions are being tested in trial NCT00316758?
The interventions under investigation include: Metformin (DRUG), GK Activator (2) (DRUG).
Who is sponsoring clinical trial NCT00316758?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00316758's enrollment target sits among peer trials
259 212th of 2000 higher than 1,789 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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