Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Multi-center, Double-blind, Parallel-group, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Denagliptin in Subjects With Type 2 Diabetes Mellitus
| Verified date | April 2015 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
GW823093 is a selective DPP-IV Inhibitor and is being investigated as a once a day oral therapy. The purpose of the Study is to evaluate the effectiveness, safety, and tolerability of 2 doses of GW823093, compared to placebo, taken once daily in patients with Type 2 diabetes mellitus.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | October 2007 |
| Est. primary completion date | October 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion criteria: - Type 2 diabetes mellitus treated with diet and exercise or oral anti-diabetic treatment - Body mass index between 20 and 40 - Females of childbearing potential must use adequate birth control. Exclusion criteria: - Subjects with previous use of insulin - Type 1 diabetes - Uncontrolled thyroid disease - History of drug or alcohol abuse in the past year - Any other clinically significant disease. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | GSK Clinical Trials Call Center | Anderson | South Carolina |
| United States | GSK Clinical Trials Call Center | Baton Rouge | Louisiana |
| United States | GSK Clinical Trials Call Center | Beaver Falls | Pennsylvania |
| United States | GSK Clinical Trials Call Center | Beverly Hills | California |
| United States | GSK Clinical Trials Call Center | Boynton Beach | Florida |
| United States | GSK Clinical Trials Call Center | Calhoun | Georgia |
| United States | GSK Clinical Trials Call Center | Carmichael | California |
| United States | GSK Clinical Trials Call Center | Charlotte | North Carolina |
| United States | GSK Clinical Trials Call Center | Chattanooga | Tennessee |
| United States | GSK Clinical Trials Call Center | Chicago | Illinois |
| United States | GSK Clinical Trials Call Center | Chicago | Illinois |
| United States | GSK Clinical Trials Call Center | Cincinnati | Ohio |
| United States | GSK Clinical Trials Call Center | Clearwater | Florida |
| United States | GSK Clinical Trials Call Center | Cleburne | Texas |
| United States | GSK Clinical Trials Call Center | Columbus | Ohio |
| United States | GSK Clinical Trials Call Center | Concord | California |
| United States | GSK Clinical Trials Call Center | Coral Gables | Florida |
| United States | GSK Clinical Trials Call Center | Detroit | Michigan |
| United States | GSK Clinical Trials Call Center | Eugene | Oregon |
| United States | GSK Clinical Trials Call Center | Fargo | North Dakota |
| United States | GSK Clinical Trials Call Center | Fleetwood | Pennsylvania |
| United States | GSK Clinical Trials Call Center | Florissant | Missouri |
| United States | GSK Clinical Trials Call Center | Guthrie | Oklahoma |
| United States | GSK Clinical Trials Call Center | Hayden Lake | Idaho |
| United States | GSK Clinical Trials Call Center | Hialeah | Florida |
| United States | GSK Clinical Trials Call Center | Hollywood | Florida |
| United States | GSK Clinical Trials Call Center | Johnson City | Tennessee |
| United States | GSK Clinical Trials Call Center | Lake Zurich | Illinois |
| United States | GSK Clinical Trials Call Center | Las Vegas | Nevada |
| United States | GSK Clinical Trials Call Center | Marrero | Louisiana |
| United States | GSK Clinical Trials Call Center | Medford | Oregon |
| United States | GSK Clinical Trials Call Center | Melbourne | Florida |
| United States | GSK Clinical Trials Call Center | Miami | Florida |
| United States | GSK Clinical Trials Call Center | Morehead City | North Carolina |
| United States | GSK Clinical Trials Call Center | Norman | Oklahoma |
| United States | GSK Clinical Trials Call Center | Oklahoma City | Oklahoma |
| United States | GSK Clinical Trials Call Center | Oklahoma City | Oklahoma |
| United States | GSK Clinical Trials Call Center | Opalocka | Florida |
| United States | GSK Clinical Trials Call Center | Oxon Hill | Maryland |
| United States | GSK Clinical Trials Call Center | Phoenix | Arizona |
| United States | GSK Clinical Trials Call Center | Plantation | Florida |
| United States | GSK Clinical Trials Call Center | Roswell | Georgia |
| United States | GSK Clinical Trials Call Center | San Antonio | Texas |
| United States | GSK Clinical Trials Call Center | Seguin | Texas |
| United States | GSK Clinical Trials Call Center | St. Louis | Missouri |
| United States | GSK Clinical Trials Call Center | St. Peters | Missouri |
| United States | GSK Clinical Trials Call Center | Tallassee | Alabama |
| United States | GSK Clinical Trials Call Center | Tampa | Florida |
| United States | GSK Clinical Trials Call Center | Torrance | California |
| United States | GSK Clinical Trials Call Center | Tucson | Arizona |
| United States | GSK Clinical Trials Call Center | Victorville | California |
| United States | GSK Clinical Trials Call Center | Warminster | Pennsylvania |
| United States | GSK Clinical Trials Call Center | Watseka | Illinois |
| United States | GSK Clinical Trials Call Center | Weber City | Virginia |
| United States | GSK Clinical Trials Call Center | Williamsville | New York |
| United States | GSK Clinical Trials Call Center | Wilmington | Delaware |
| United States | GSK Clinical Trials Call Center | Yukon | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in blood glucose regulation after 26 weeks of treatment | |||
| Secondary | Change from baseline in glycemic parameters, insulin, body weight and waist circumference, and safety measures |
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