NCT01474083

A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes

A Multi-Center, Randomized, Double-Blind, Parallel-Group, Multiple-Dose Study Assessing the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GK1-399 in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: vTv Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	GK1-399 (formerly TTP399)	Treatment A: GK1-399 200 mg. Oral administration, twice per day.
DRUG	GK1-399 (formerly TTP399)	Treatment B: GK1-399 800 mg. Oral administration, once per day.
DRUG	GK1-399 (formerly TTP399)	Treatment C: GK1-399 800 mg. Oral administration, twice per day.
DRUG	Placebo	Dose-matched placebo. Oral administration.

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-08-01
• Completion: 2012-09-01
• First posted: 2011-11-18
• Last updated: 2013-09-13

Locations

11 sites across 1 country: United States