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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01474083

Run by

vTv Therapeutics

People needed

248

Starts

2011-11-01

Expected to finish

2012-09-01

Last updated by the study team

2013-09-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

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

Where it is running

• Forest Investigative Site 009 — Little Rock, Arkansas, United States
• Forest Investigative Site 006 — Chula Vista, California, United States
• Forest Investigative Site 002 — DeLand, Florida, United States
• Forest Investigative Site 001 — Miami, Florida, United States
• Forest Investigative Site 010 — Overland Park, Kansas, United States
• Forest Investigative site 011 — Saint Paul, Minnesota, United States
• Forest Investigative Site 005 — Springfield, Missouri, United States
• Forest Investigative Site 003 — Neptune City, New Jersey, United States
• Forest Investigative Site 008 — Willingboro, New Jersey, United States
• Forest Investigative Site 007 — New York, New York, United States
• Forest Investigative Site 004 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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