drugset / Trial / NCT01474083

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

NCT01474083 ↗

Phase 1/2 Completed 248 enrolled vTv Therapeutics
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

EvaluationDrugModalityDoseRoute
Subject GK1-399 Unknown 200 mg Oral
Subject GK1-399 Unknown 800 mg Oral