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NCT00377442 · ClinicalTrials.gov registry record · Phase 1
A Drug-Drug Interaction Study of GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes.
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT00377442 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 33 participants.
The verdict
NCT00377442, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
This study will assess the potential pharmacokinetic interaction between GK Activator (2) and simvastatin, and the potential effect of simvastatin on the glucose-lowering effect of GK Activator (2) in patients with type 2 diabetes. Patients will be randomized to one of 6 treatment sequences to receive single doses of a)GK Activator (2) 100mg po, b)simvastatin 80mg po and c)GK Activator (2) 100mg + simvastatin 80mg po. Dosing will take place on study days 1, 8 and 15, and there will be a 7-14 day follow-up period after the last dose. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
Interventions
- DRUG Simvastatin
- DRUG GK Activator (2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2006-08 |
| Est. Completion | 2007-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00377442
The ClinicalTrials.gov registry entry for NCT00377442 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 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 2 interventions - of which Simvastatin is the first listed.
NCT00377442 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00377442 about?
NCT00377442 is a clinical study titled "A Drug-Drug Interaction Study of GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes.". This study will assess the potential pharmacokinetic interaction between GK Activator (2) and simvastatin, and the potential effect of simvastatin on the glucose-lowering effect of GK Activator (2) in patients with type 2 diabetes. Patients will be randomized to one of 6 treatment sequences to recei...
What is the current status of trial NCT00377442?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2006-08. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00377442?
The interventions under investigation include: Simvastatin (DRUG), GK Activator (2) (DRUG).
Who is sponsoring clinical trial NCT00377442?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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