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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GK1-399, low dose | Experimental |
| |
| GK1-399, high dose, once per day | Experimental |
| |
| GK1-399, high dose, twice per day | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GK1-399 (formerly TTP399) | Drug | Treatment A: GK1-399 200 mg. Oral administration, twice per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of GK1-399 from plasma concentrations | Area under the plasma concentration verses time curve from time 0 to the end of the dosing interval, maximum plasma concentration | 52 time points over a 6 week period |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic parameters of plasma glucose | Fasting plasma glucose and postprandial plasma glucose | 52 time points over a 6 week period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Burstein, Pharm.D. | TransTech Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 009 | Little Rock | Arkansas | 72211 | United States | ||
| Forest Investigative Site 006 |
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| GK1-399 (formerly TTP399) | Drug | Treatment B: GK1-399 800 mg. Oral administration, once per day. |
|
| GK1-399 (formerly TTP399) | Drug | Treatment C: GK1-399 800 mg. Oral administration, twice per day. |
|
| Placebo | Drug | Dose-matched placebo. Oral administration. |
|
| Chula Vista |
| California |
| 91911 |
| United States |
| Forest Investigative Site 002 | DeLand | Florida | 32720 | United States |
| Forest Investigative Site 001 | Miami | Florida | 33014 | United States |
| Forest Investigative Site 010 | Overland Park | Kansas | 66212 | United States |
| Forest Investigative site 011 | Saint Paul | Minnesota | 55114 | United States |
| Forest Investigative Site 005 | Springfield | Missouri | 65802 | United States |
| Forest Investigative Site 003 | Neptune City | New Jersey | 07753 | United States |
| Forest Investigative Site 008 | Willingboro | New Jersey | 08046 | United States |
| Forest Investigative Site 007 | New York | New York | 10029 | United States |
| Forest Investigative Site 004 | San Antonio | Texas | 78209 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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