A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes

vTv Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: GK1-399 (formerly TTP399); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01474083

GK1-MS-201

Details and patient eligibility

About

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.

Enrollment: 248 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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248 participants in 4 patient groups, including a placebo group

GK1-399, low dose

Experimental group

Treatment:

Drug: GK1-399 (formerly TTP399)

Drug: GK1-399 (formerly TTP399)

Drug: GK1-399 (formerly TTP399)

GK1-399, high dose, once per day

Experimental group

Treatment:

Drug: GK1-399 (formerly TTP399)

Drug: GK1-399 (formerly TTP399)

Drug: GK1-399 (formerly TTP399)

GK1-399, high dose, twice per day

Experimental group

Treatment:

Drug: GK1-399 (formerly TTP399)

Drug: GK1-399 (formerly TTP399)

Drug: GK1-399 (formerly TTP399)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo