Back to resultsA 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GK1-399 (formerly TTP399)
GK1-399 (formerly TTP399)
GK1-399 (formerly TTP399)
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes mellitus, pharmacokinetics, pharmacodynamics
Eligibility 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
Sites / Locations
- Forest Investigative Site 009
- Forest Investigative Site 006
- Forest Investigative Site 002
- Forest Investigative Site 001
- Forest Investigative Site 010
- Forest Investigative site 011
- Forest Investigative Site 005
- Forest Investigative Site 003
- Forest Investigative Site 008
- Forest Investigative Site 007
- Forest Investigative Site 004
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
GK1-399, low dose
GK1-399, high dose, once per day
GK1-399, high dose, twice per day
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Pharmacodynamic parameters of plasma glucose
Fasting plasma glucose and postprandial plasma glucose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01474083
Brief Title
A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes
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 Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
vTv Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 diabetes mellitus, pharmacokinetics, pharmacodynamics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GK1-399, low dose
Arm Type
Experimental
Arm Title
GK1-399, high dose, once per day
Arm Type
Experimental
Arm Title
GK1-399, high dose, twice per day
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
GK1-399 (formerly TTP399)
Intervention Description
Treatment A: GK1-399 200 mg. Oral administration, twice per day.
Intervention Type
Drug
Intervention Name(s)
GK1-399 (formerly TTP399)
Intervention Description
Treatment B: GK1-399 800 mg. Oral administration, once per day.
Intervention Type
Drug
Intervention Name(s)
GK1-399 (formerly TTP399)
Intervention Description
Treatment C: GK1-399 800 mg. Oral administration, twice per day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dose-matched placebo. Oral administration.
Primary Outcome Measure Information:
Title
Pharmacokinetic parameters of GK1-399 from plasma concentrations
Description
Area under the plasma concentration verses time curve from time 0 to the end of the dosing interval, maximum plasma concentration
Time Frame
52 time points over a 6 week period
Secondary Outcome Measure Information:
Title
Pharmacodynamic parameters of plasma glucose
Description
Fasting plasma glucose and postprandial plasma glucose
Time Frame
52 time points over a 6 week period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Burstein, Pharm.D.
Organizational Affiliation
TransTech Pharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 009
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Forest Investigative Site 006
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Forest Investigative Site 002
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Forest Investigative Site 001
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Forest Investigative Site 010
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Forest Investigative site 011
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
Forest Investigative Site 005
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
Forest Investigative Site 003
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Forest Investigative Site 008
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Forest Investigative Site 007
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Forest Investigative Site 004
City
San Antonio,
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes
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