A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes
This study has been completed.
Sponsor:
TransTech Pharma
Information provided by (Responsible Party):
TransTech Pharma
ClinicalTrials.gov Identifier:
NCT01474083
First received: November 15, 2011
Last updated: April 19, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: GK1-399 (formerly TTP399) Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by TransTech Pharma:
Primary Outcome Measures:
- Pharmacokinetic parameters of GK1-399 from plasma concentrations [ Time Frame: 52 time points over a 6 week period ] [ Designated as safety issue: No ]Area under the plasma concentration verses time curve from time 0 to the end of the dosing interval, maximum plasma concentration
Secondary Outcome Measures:
- Pharmacodynamic parameters of plasma glucose [ Time Frame: 52 time points over a 6 week period ] [ Designated as safety issue: No ]Fasting plasma glucose and postprandial plasma glucose
| Enrollment: | 248 |
| Study Start Date: | November 2011 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: GK1-399, low dose |
Drug: GK1-399 (formerly TTP399)
Treatment A: GK1-399 200 mg. Oral administration, twice per day.
|
| Experimental: GK1-399, high dose, once per day |
Drug: GK1-399 (formerly TTP399)
Treatment B: GK1-399 800 mg. Oral administration, once per day.
|
| Experimental: GK1-399, high dose, twice per day |
Drug: GK1-399 (formerly TTP399)
Treatment C: GK1-399 800 mg. Oral administration, twice per day.
|
| Placebo Comparator: Placebo |
Drug: Placebo
Dose-matched placebo. Oral administration.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474083
Locations
| United States, Arkansas | |
| Forest Investigative Site 009 | |
| Little Rock, Arkansas, United States, 72211 | |
| United States, California | |
| Forest Investigative Site 006 | |
| Chula Vista, California, United States, 91911 | |
| United States, Florida | |
| Forest Investigative Site 002 | |
| Deland, Florida, United States, 32720 | |
| Forest Investigative Site 001 | |
| Miami, Florida, United States, 33014 | |
| United States, Kansas | |
| Forest Investigative Site 010 | |
| Overland Park, Kansas, United States, 66212 | |
| United States, Minnesota | |
| Forest Investigative site 011 | |
| St. Paul, Minnesota, United States, 55114 | |
| United States, Missouri | |
| Forest Investigative Site 005 | |
| Springfield, Missouri, United States, 65802 | |
| United States, New Jersey | |
| Forest Investigative Site 003 | |
| Neptune, New Jersey, United States, 07753 | |
| Forest Investigative Site 008 | |
| Willingboro, New Jersey, United States, 08046 | |
| United States, New York | |
| Forest Investigative Site 007 | |
| New York, New York, United States, 10029 | |
| United States, Texas | |
| Forest Investigative Site 004 | |
| San Antonio,, Texas, United States, 78209 | |
Sponsors and Collaborators
TransTech Pharma
Investigators
| Study Director: | Aaron Burstein, Pharm.D. | TransTech Pharma, Inc. |
More Information
No publications provided
| Responsible Party: | TransTech Pharma |
| ClinicalTrials.gov Identifier: | NCT01474083 History of Changes |
| Other Study ID Numbers: | GK1-MS-201 |
| Study First Received: | November 15, 2011 |
| Last Updated: | April 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by TransTech Pharma:
|
Type 2 diabetes mellitus pharmacokinetics pharmacodynamics |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013