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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: vTv Therapeutics

Criteria

Inclusion Criteria:

• Be male or female, aged 18 through 75 years at screening.

• Have a diagnosis of Type 2 Diabetes Mellitus (T2DM)

• On a stable dose of background medication for the treatment of diabetes

• Body Mass Index (BMI) between 20-40 kg/m2 (inclusive)

Exclusion Criteria:

• Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease