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NCT00366379 · ClinicalTrials.gov registry record · Phase 2
A Dose-Titration Study 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
- 127
- Enrollment target
NCT00366379 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 127 participants.
The verdict
NCT00366379, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 127 participants
- Enrollment target
Study Summary
This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of \<100mg/dL. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
Interventions
- DRUG GK Activator (2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2006-07 |
| Est. Completion | 2007-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00366379
The ClinicalTrials.gov registry entry for NCT00366379 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GK Activator (2) is the first listed.
NCT00366379 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00366379 about?
NCT00366379 is a clinical study titled "A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.". This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, pat...
What is the current status of trial NCT00366379?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 127 participants. The study started on 2006-07. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00366379?
The interventions under investigation include: GK Activator (2) (DRUG).
Who is sponsoring clinical trial NCT00366379?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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