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NCT01474083 · ClinicalTrials.gov registry record · Phase 1
A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes
A Phase 1 study, sponsored by vTv Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 248
- Enrollment target
NCT01474083: Completed Phase 1 study, sponsored by vTv Therapeutics.
NCT01474083 is a Phase 1 study that has completed, run by vTv Therapeutics. The registered enrollment target is 248 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (313% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01474083, a Phase 1 study, has completed, sponsored by vTv Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 248 participants
- Enrollment target
Study Summary
The purpose of this trial is to study the drug levels and biomarkers in the body and the safety of an investigational drug (GK1-399) in patients with Type 2 diabetes. Patients in the study will receive placebo for 1 week followed by 1 of 4 treatments for 6 weeks. One of the 4 treatments will be placebo, which does not contain an active ingredient. The study participation includes in-patient and out-patient days.
Primary Outcome
Area under the plasma concentration verses time curve from time 0 to the end of the dosing interval, maximum plasma concentration
Interventions
- DRUG Placebo
- DRUG GK1-399 (formerly TTP399)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
What the finished NCT01474083 record still lists
NCT01474083 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (313% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01474083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01474083 about?
NCT01474083 is a clinical study titled "A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes". The purpose of this trial is to study the drug levels and biomarkers in the body and the safety of an investigational drug (GK1-399) in patients with Type 2 diabetes. Patients in the study will receive placebo for 1 week followed by 1 of 4 treatments for 6 weeks. One of the 4 treatments will be plac...
What is the current status of trial NCT01474083?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 248 participants. The study started on 2011-11. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01474083?
The interventions under investigation include: Placebo (DRUG), GK1-399 (formerly TTP399) (DRUG).
Who is sponsoring clinical trial NCT01474083?
This trial is sponsored by vTv Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01474083's enrollment target sits among peer trials
248 185th of 2000 higher than 1,814 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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