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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: GK1-399 (formerly TTP399); Drug: Placebo

• Registration Number: NCT01474083
• Lead Sponsor: vTv Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-18
• Primary Completion: 2012-08
• Study Completion: 2012-09
• Disposition First Submitted: 2012-10-03
• Disposition First Submitted QC: 2012-10-03
• Disposition First Posted: 2012-10-05
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-03
• Last Update Posted: 2013-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GK1-399, low dose	GK1-399 (formerly TTP399)	-
GK1-399, high dose, once per day	GK1-399 (formerly TTP399)	-
GK1-399, high dose, twice per day	GK1-399 (formerly TTP399)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of GK1-399 from plasma concentrations	52 time points over a 6 week period	Area under the plasma concentration verses time curve from time 0 to the end of the dosing interval, maximum plasma concentration

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic parameters of plasma glucose	52 time points over a 6 week period	Fasting plasma glucose and postprandial plasma glucose

Trial Locations

Locations (11)

Forest Investigative Site 010; 🇺🇸 Overland Park, Kansas, United States

Forest Investigative Site 005; 🇺🇸 Springfield, Missouri, United States

Forest Investigative Site 003; 🇺🇸 Neptune, New Jersey, United States

Forest Investigative Site 006; 🇺🇸 Chula Vista, California, United States

Forest Investigative Site 008; 🇺🇸 Willingboro, New Jersey, United States

Forest Investigative Site 002; 🇺🇸 Deland, Florida, United States

Forest Investigative Site 004; 🇺🇸 San Antonio,, Texas, United States

Forest Investigative site 011; 🇺🇸 St. Paul, Minnesota, United States

Forest Investigative Site 009; 🇺🇸 Little Rock, Arkansas, United States

Forest Investigative Site 001; 🇺🇸 Miami, Florida, United States

Forest Investigative Site 007; 🇺🇸 New York, New York, United States