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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: GK1-399 (formerly TTP399); Drug: GK1-399 (formerly TTP399); Drug: GK1-399 (formerly TTP399); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Forest Investigative Site 009
  • California
    • Chula Vista, California, United States, 91911
      • Forest Investigative Site 006
  • Florida
    • Deland, Florida, United States, 32720
      • Forest Investigative Site 002
    • Miami, Florida, United States, 33014
      • Forest Investigative Site 001
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Forest Investigative Site 010
  • Minnesota
    • St. Paul, Minnesota, United States, 55114
      • Forest Investigative Site 011
  • Missouri
    • Springfield, Missouri, United States, 65802
      • Forest Investigative Site 005
  • New Jersey
    • Neptune, New Jersey, United States, 07753
      • Forest Investigative Site 003
    • Willingboro, New Jersey, United States, 08046
      • Forest Investigative Site 008
  • New York
    • New York, New York, United States, 10029
      • Forest Investigative Site 007
  • Texas
    • San Antonio,, Texas, United States, 78209
      • Forest Investigative Site 004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Dose-matched placebo. Oral administration.
Experimental: GK1-399, low dose	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.
Experimental: GK1-399, high dose, once per day	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.
Experimental: GK1-399, high dose, twice per day	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamic parameters of plasma glucose	Fasting plasma glucose and postprandial plasma glucose	52 time points over a 6 week period

Collaborators and Investigators

• Sponsor: vTv Therapeutics
• Investigators: Study Director: Aaron Burstein, Pharm.D., TransTech Pharma, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: November 15, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (Estimate): November 18, 2011

Study Record Updates

• Last Update Posted (Estimate): September 13, 2013
• Last Update Submitted That Met QC Criteria: September 3, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: pharmacokinetics; Type 2 diabetes mellitus; pharmacodynamics
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: GK1-MS-201