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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TransTech Pharma
ClinicalTrials.gov Identifier:
NCT01474083
First received: November 15, 2011
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: GK1-399 (formerly TTP399)
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
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
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

Resource links provided by NLM:


Further study details as provided by TransTech Pharma:

Primary Outcome Measures:
  • Pharmacokinetic parameters of GK1-399 from plasma concentrations [ Time Frame: 52 time points over a 6 week period ] [ Designated as safety issue: No ]
    Area under the plasma concentration verses time curve from time 0 to the end of the dosing interval, maximum plasma concentration


Secondary Outcome Measures:
  • Pharmacodynamic parameters of plasma glucose [ Time Frame: 52 time points over a 6 week period ] [ Designated as safety issue: No ]
    Fasting plasma glucose and postprandial plasma glucose


Enrollment: 248
Study Start Date: November 2011
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
TransTech Pharma
Investigators
Study Director: Aaron Burstein, Pharm.D. TransTech Pharma, Inc.
  More Information

No publications provided

Responsible Party: TransTech Pharma
ClinicalTrials.gov Identifier: NCT01474083     History of Changes
Other Study ID Numbers: GK1-MS-201
Study First Received: November 15, 2011
Last Updated: September 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by TransTech Pharma:
Type 2 diabetes mellitus
pharmacokinetics
pharmacodynamics

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

ClinicalTrials.gov processed this record on November 25, 2014