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

NCT ID: NCT01474083

Last Updated: 2013-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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Type 2 diabetes mellitus pharmacokinetics pharmacodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GK1-399, low dose

Group Type EXPERIMENTAL

GK1-399 (formerly TTP399)

Intervention Type DRUG

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

GK1-399, high dose, once per day

Group Type EXPERIMENTAL

GK1-399 (formerly TTP399)

Intervention Type DRUG

Treatment B: GK1-399 800 mg. Oral administration, once per day.

GK1-399, high dose, twice per day

Group Type EXPERIMENTAL

GK1-399 (formerly TTP399)

Intervention Type DRUG

Treatment C: GK1-399 800 mg. Oral administration, twice per day.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose-matched placebo. Oral administration.

Interventions

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GK1-399 (formerly TTP399)

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

Intervention Type DRUG

GK1-399 (formerly TTP399)

Treatment B: GK1-399 800 mg. Oral administration, once per day.

Intervention Type DRUG

GK1-399 (formerly TTP399)

Treatment C: GK1-399 800 mg. Oral administration, twice per day.

Intervention Type DRUG

Placebo

Dose-matched placebo. Oral administration.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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vTv Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aaron Burstein, Pharm.D.

Role: STUDY_DIRECTOR

TransTech Pharma, Inc.

Locations

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Forest Investigative Site 009

Little Rock, Arkansas, United States

Site Status

Forest Investigative Site 006

Chula Vista, California, United States

Site Status

Forest Investigative Site 002

DeLand, Florida, United States

Site Status

Forest Investigative Site 001

Miami, Florida, United States

Site Status

Forest Investigative Site 010

Overland Park, Kansas, United States

Site Status

Forest Investigative site 011

Saint Paul, Minnesota, United States

Site Status

Forest Investigative Site 005

Springfield, Missouri, United States

Site Status

Forest Investigative Site 003

Neptune City, New Jersey, United States

Site Status

Forest Investigative Site 008

Willingboro, New Jersey, United States

Site Status

Forest Investigative Site 007

New York, New York, United States

Site Status

Forest Investigative Site 004

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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GK1-MS-201

Identifier Type: -

Identifier Source: org_study_id