Type 2 Diabetes in Obese Subjects Clinical Trial
— ENDOOfficial title:
A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents
| Verified date | October 2014 |
| Source | GI Dynamics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes
| Status | Terminated |
| Enrollment | 406 |
| Est. completion date | December 2016 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - HbA1c = 7.5% and = 10% - BMI = 30 and = 55 Exclusion Criteria: - Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis - C-peptide < 1.0 ng/mL - Previous GI surgery or abnormal GI anatomical finding - Prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Emory University | Atlanta | Georgia |
| United States | University of Colorado/ Anschutz Health & Wellness Center | Aurora | Colorado |
| United States | Billings Clinic | Billings | Montana |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Boston Medical Center | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | University of North Carolina | Chapel Hill | North Carolina |
| United States | Northwestern University | Chicago | Illinois |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Dallas Diabetes | Dallas | Texas |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | The Methodist Hospital Research Institute | Houston | Texas |
| United States | MedStar Health Research Institute | Hyattsville | Maryland |
| United States | Endocrinology Consultants of East Tennessee & Gastrointestinal Associates | Knoxville | Tennessee |
| United States | Little Rock Diagnostic Center (LRDC) | Little Rock | Arkansas |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Kentucky Research Group | Louisville | Kentucky |
| United States | Tulane University Health Sciences Center | New Orleans | Louisiana |
| United States | Beth Israel Medical Center | New York | New York |
| United States | Legacy Research Institute | Portland | Oregon |
| United States | Mayo Clinic Minnesota | Rochester | Minnesota |
| United States | Mayo Clinic Arizona | Scottsdale | Arizona |
| United States | Washington University | St Louis | Missouri |
| United States | Stanford University School of Medicine | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| GI Dynamics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement in HbA1c | 12 months | No | |
| Secondary | Weight Loss | 12 Months | No | |
| Secondary | Improvements in select cardiovascular risk factors, such as cholesterol | 12 Months | No |