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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
248
Treatment A: GK1-399 200 mg. Oral administration, twice per day.
Treatment B: GK1-399 800 mg. Oral administration, once per day.
Treatment C: GK1-399 800 mg. Oral administration, twice per day.
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
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
Time frame: 52 time points over a 6 week period
Pharmacodynamic parameters of plasma glucose
Fasting plasma glucose and postprandial plasma glucose
Time frame: 52 time points over a 6 week period
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Dose-matched placebo. Oral administration.
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
...and 1 more locations