Diabetes Mellitus, Type 2 Clinical Trial
Official title:
An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes Mellitus
| Verified date | January 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.
| Status | Completed |
| Enrollment | 456 |
| Est. completion date | September 2006 |
| Est. primary completion date | September 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - The subject has an HbA1c value <=11.0% - The subject has a body mass index (BMI) of 25 kg/m^2 to 45 kg/m^2, inclusive Exclusion Criteria: - Is currently treated with certain medications, including exogenous insulin |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Anaheim | California |
| United States | Research Site | Aurora | Colorado |
| United States | Research Site | Bellflower | California |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Blairsville | Georgia |
| United States | Research Site | Burlingame | California |
| United States | Research Site | Butte | Montana |
| United States | Research Site | Camp Hill | Pennsylvania |
| United States | Research Site | Cary | North Carolina |
| United States | Research Site | Chesterfield | Missouri |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Chula Vista | California |
| United States | Research Site | Clinton | Oklahoma |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Concord | California |
| United States | Research Site | Covington | Louisiana |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | Edina | Minnesota |
| United States | Research Site | Encino | California |
| United States | Research Site | Fremont | California |
| United States | Research Site | Gainesville | Florida |
| United States | Research Site | Gulfport | Mississippi |
| United States | Research Site | Honolulu | Hawaii |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | La Jolla | California |
| United States | Research Site | Largo | Florida |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Los Gatos | California |
| United States | Research Site | Maitland | Florida |
| United States | Research Site | Marion | Ohio |
| United States | Research Site | Maumee | Ohio |
| United States | Research Site | Medford | Oregon |
| United States | Research Site | Mentor | Ohio |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Midland | Texas |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Moreno Valley | California |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | New York | New York |
| United States | Research Site | Ocala | Florida |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Olympia | Washington |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Picayune | Mississippi |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Redwood City | California |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Mateo | California |
| United States | Research Site | Slidell | Louisiana |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | St. Louis | Missouri |
| United States | Research Site | Walnut Creek | California |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
Blonde L, Klein EJ, Han J, Zhang B, Mac SM, Poon TH, Taylor KL, Trautmann ME, Kim DD, Kendall DM. Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 di — View Citation
Buse JB, Klonoff DC, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Maggs DG, Wintle ME. Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the — View Citation
Klonoff DC, Buse JB, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Wintle ME, Maggs DG. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Op — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit | Change in HbA1c from Visit 1 to each visit up to open-ended study termination | Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) | No |
| Primary | Change in body weight from Visit 1 to each protocol visit | Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination | Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) | No |
| Primary | Change in fasting plasma glucose from Visit 1 to each protocol visit | Change in fasting plasma glucose from Visit 1 to each visit up to open-ended study termination | Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) | No |
| Primary | Change in lipids from Visit 1 to each protocol visit | Change in lipids from Visit 1 to each visit up to open-ended study termination | Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) | No |
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