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
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- vTv Therapeutics
- Enrollment
- 248
- Locations
- 11
- Primary Endpoint
- Pharmacokinetic parameters of GK1-399 from plasma concentrations
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
GK1-399, low dose
Intervention: GK1-399 (formerly TTP399) (Drug)
GK1-399, high dose, once per day
Intervention: GK1-399 (formerly TTP399) (Drug)
GK1-399, high dose, twice per day
Intervention: GK1-399 (formerly TTP399) (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic parameters of GK1-399 from plasma concentrations
Time Frame: 52 time points over a 6 week period
Area under the plasma concentration verses time curve from time 0 to the end of the dosing interval, maximum plasma concentration
Secondary Outcomes
- Pharmacodynamic parameters of plasma glucose(52 time points over a 6 week period)