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
1 other identifier
interventional
248
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 type-2-diabetes-mellitus
Started Nov 2011
Typical duration for phase_1 type-2-diabetes-mellitus
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 15, 2011
CompletedFirst Posted
Study publicly available on registry
November 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedSeptember 13, 2013
September 1, 2013
9 months
November 15, 2011
September 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Pharmacodynamic parameters of plasma glucose
52 time points over a 6 week period
Study Arms (4)
GK1-399, low dose
EXPERIMENTALGK1-399, high dose, once per day
EXPERIMENTALGK1-399, high dose, twice per day
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Treatment A: GK1-399 200 mg. Oral administration, twice per day.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- vTv Therapeuticslead
Study Sites (11)
Forest Investigative Site 009
Little Rock, Arkansas, 72211, United States
Forest Investigative Site 006
Chula Vista, California, 91911, United States
Forest Investigative Site 002
DeLand, Florida, 32720, United States
Forest Investigative Site 001
Miami, Florida, 33014, United States
Forest Investigative Site 010
Overland Park, Kansas, 66212, United States
Forest Investigative site 011
Saint Paul, Minnesota, 55114, United States
Forest Investigative Site 005
Springfield, Missouri, 65802, United States
Forest Investigative Site 003
Neptune City, New Jersey, 07753, United States
Forest Investigative Site 008
Willingboro, New Jersey, 08046, United States
Forest Investigative Site 007
New York, New York, 10029, United States
Forest Investigative Site 004
San Antonio, Texas, 78209, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Aaron Burstein, Pharm.D.
TransTech Pharma, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2011
First Posted
November 18, 2011
Study Start
November 1, 2011
Primary Completion
August 1, 2012
Study Completion
September 1, 2012
Last Updated
September 13, 2013
Record last verified: 2013-09