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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: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT00368368 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00368368 record still lists
NCT00368368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which GK Activator (2) is the first listed.
NCT00368368 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00368368's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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