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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01474083
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : September 13, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: GK1-399 (formerly TTP399) Drug: Placebo Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Study Start Date : November 2011
Primary Completion Date : August 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: GK1-399, low dose Drug: GK1-399 (formerly TTP399)
Treatment A: GK1-399 200 mg. Oral administration, twice per day.
Experimental: GK1-399, high dose, once per day Drug: GK1-399 (formerly TTP399)
Treatment B: GK1-399 800 mg. Oral administration, once per day.
Experimental: GK1-399, high dose, twice per day Drug: GK1-399 (formerly TTP399)
Treatment C: GK1-399 800 mg. Oral administration, twice per day.
Placebo Comparator: Placebo Drug: Placebo
Dose-matched placebo. Oral administration.


Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetic parameters of GK1-399 from plasma concentrations [ Time Frame: 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 :
  1. Pharmacodynamic parameters of plasma glucose [ Time Frame: 52 time points over a 6 week period ]
    Fasting plasma glucose and postprandial plasma glucose


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474083


Locations
United States, Arkansas
Forest Investigative Site 009
Little Rock, Arkansas, United States, 72211
United States, California
Forest Investigative Site 006
Chula Vista, California, United States, 91911
United States, Florida
Forest Investigative Site 002
Deland, Florida, United States, 32720
Forest Investigative Site 001
Miami, Florida, United States, 33014
United States, Kansas
Forest Investigative Site 010
Overland Park, Kansas, United States, 66212
United States, Minnesota
Forest Investigative site 011
St. Paul, Minnesota, United States, 55114
United States, Missouri
Forest Investigative Site 005
Springfield, Missouri, United States, 65802
United States, New Jersey
Forest Investigative Site 003
Neptune, New Jersey, United States, 07753
Forest Investigative Site 008
Willingboro, New Jersey, United States, 08046
United States, New York
Forest Investigative Site 007
New York, New York, United States, 10029
United States, Texas
Forest Investigative Site 004
San Antonio,, Texas, United States, 78209
Sponsors and Collaborators
vTv Therapeutics
Investigators
Study Director: Aaron Burstein, Pharm.D. TransTech Pharma, Inc.
More Information

Responsible Party: vTv Therapeutics
ClinicalTrials.gov Identifier: NCT01474083     History of Changes
Other Study ID Numbers: GK1-MS-201
First Posted: November 18, 2011    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: September 2013

Keywords provided by vTv Therapeutics:
Type 2 diabetes mellitus
pharmacokinetics
pharmacodynamics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases