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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474083
• Other study ID #: GK1-MS-201
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 15, 2011
• Last updated: September 3, 2013
• Start date: November 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2013
• Source: vTv Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• GK1-399 (formerly TTP399)
Treatment A: GK1-399 200 mg. Oral administration, twice per day.
• GK1-399 (formerly TTP399)
Treatment B: GK1-399 800 mg. Oral administration, once per day.
• GK1-399 (formerly TTP399)
Treatment C: GK1-399 800 mg. Oral administration, twice per day.
• Placebo
Dose-matched placebo. Oral administration.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
vTv Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacodynamic parameters of plasma glucose	Fasting plasma glucose and postprandial plasma glucose	52 time points over a 6 week period	No