drugset / Trial / NCT01474083
A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes
RandomizedParallel-groupQuadruple-blindBasic science
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.
Timeline
- Start
- 2011-11
- Primary completion
- 2012-08
- Completion
- 2012-09
Outcome
Met primary endpoint
release “In a phase 2a study, TTP399 demonstrated a statistically significant and clinically meaningful reduction in A1c levels compared with placebo after only 6 weeks” vtvtherapeutics.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GK1-399 | Unknown | 200 mg | Oral |
| Subject | GK1-399 | Unknown | 800 mg | Oral |