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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
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Forest Investigative Site 009
Little Rock, Arkansas, United States
Forest Investigative Site 006
Chula Vista, California, United States
Forest Investigative Site 002
DeLand, Florida, United States
Forest Investigative Site 001
Miami, Florida, United States
Forest Investigative Site 010
Overland Park, Kansas, United States
Forest Investigative site 011
Saint Paul, Minnesota, United States
Forest Investigative Site 005
Springfield, Missouri, United States
Forest Investigative Site 003
Neptune City, New Jersey, United States
Forest Investigative Site 008
Willingboro, New Jersey, United States
Forest Investigative Site 007
New York, New York, United States
Start Date
November 1, 2011
Primary Completion Date
August 1, 2012
Completion Date
September 1, 2012
Last Updated
September 13, 2013
248
ACTUAL participants
GK1-399 (formerly TTP399)
DRUG
GK1-399 (formerly TTP399)
DRUG
GK1-399 (formerly TTP399)
DRUG
Placebo
DRUG
Lead Sponsor
vTv Therapeutics
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04943861