Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
| Verified date | March 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes who are not achieving glycemic targets.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | June 2006 |
| Est. primary completion date | June 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Has HbA1c >7.0% and <=10.5% - Has a body mass index (BMI) >=25 kg/m2 and <=45 kg/m2 - Has received insulin glargine for 3 months prior to study start and has been on a stable dose for 1 month prior to study start - If taking oral antidiabetic agents, has been on a stable dose for at least 2 months Exclusion Criteria: - Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study) - Has received any investigational drug within 1 month of screening |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Baton Rouge | Louisiana |
| United States | Research Site | Bloomfield Hills | Michigan |
| United States | Research Site | Butte | Montana |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Charlottesville | Virginia |
| United States | Research Site | Chesterfield | Missouri |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Concord | California |
| 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 | Grand Rapids | Michigan |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | La Jolla | California |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Los Gatos | California |
| United States | Research Site | Medford | Oregon |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | New Britain | Connecticut |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Olympia | Washington |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Palm Harbor | Florida |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Salinas | California |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Tipton | Pennsylvania |
| United States | Research Site | Walnut Creek | California |
| United States | Research Site | Washington | District of Columbia |
| United States | Research Site | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes. | 16 Weeks | ||
| Secondary | To evaluate the effects of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes on markers of cardiovascular risk, fasting serum lipids, fasting plasma glucose, waist circumference, and patient-reported outcomes. | 16 Weeks |
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