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NCT Number: NCT01474083

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Forest Investigative Site 009, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GK1-399 (formerly TTP399)

Drug

Treatment A: GK1-399 200 mg. Oral administration, twice per day.

Placebo

Drug

Dose-matched placebo. Oral administration.

Primary outcomes

  1. 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

  1. Pharmacodynamic parameters of plasma glucose

    Time frame: 52 time points over a 6 week period

    Fasting plasma glucose and postprandial plasma glucose

Sponsors and collaborators

Lead sponsor

vTv Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 18, 2011
Registry last updated
Sep 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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