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NCT00368368 · ClinicalTrials.gov registry record · Phase 1
A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT00368368 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 5 participants.
The verdict
NCT00368368, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This study will investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and will evaluate the effect of renal function on the safety of the drug. Patients will be assigned to treatment groups according to their renal function (normal, moderate renal impairment, or severe renal impairment). After a 1 week washout period from current oral anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator (2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
Interventions
- DRUG GK Activator (2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2006-01 |
| Est. Completion | 2007-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00368368
The ClinicalTrials.gov registry entry for NCT00368368 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 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.
NCT00368368 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00368368 about?
NCT00368368 is a clinical study titled "A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.". This study will investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and will evaluate the effect of renal function on the safety of the drug. Patients will be assigned to treatment groups according to their renal f...
What is the current status of trial NCT00368368?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2006-01. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00368368?
The interventions under investigation include: GK Activator (2) (DRUG).
Who is sponsoring clinical trial NCT00368368?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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