Safety, Tolerability, Immunological and Clinical Efficacy of Multiple Subcutaneous Doses of DiaPep277 in Latent Autoimmune Diabetes in Adults (LADA)
- Conditions
- Diabetes, Autoimmune
- Registration Number
- NCT00058981
- Lead Sponsor
- DeveloGen Israel, Ltd.
- Brief Summary
Randomized, double-blind, parallel-group study to evaluate safety and efficacy of multiple subcutaneous doses of DiaPep277 in patients with Latent Autoimmune Diabetes in Adults (LADA). Study medication will be administered at time 0, 1 and 3 months, and then every 3 months for a total of 8 administrations. The total duration of the trial is 24 months (treatment for 18 months and follow-up for an additional 6 months). Patients will be male or female between the ages of 30 and 65 years, inclusive, within 2 to 60 months of the diagnosis of diabetes mellitus. Subjects must be positive for glutamic acid decarboxylate (GAD) autoantibodies. At the Screen Visit (Visit 2), all subjects will be asked to discontinue their use of all oral antidiabetic medications with the exception of metformin. The subjects will be placed on a stable regimen of insulin and diet (plus metformin if needed). Prior to the Baseline Visit (Visit 3), diabetic control must be achieved by diet and insulin (plus metformin if needed).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
University of Colorado Hospital Endocrinology Practice
🇺🇸Aurora, Colorado, United States
University of Alabama at Birmingham Endocrinology Department
🇺🇸Birmingham, Alabama, United States
University of Kentucky Department of Internal Medicine
🇺🇸Lexington, Kentucky, United States
Washington University School of Medicine Endocrinology/Metabolic Dept
🇺🇸Saint Louis, Missouri, United States
North Shore Diabetes and Endocrine Associates
🇺🇸New Hyde Park, New York, United States
DVA Puget Sound Health Care System Endocrinology (III) Department
🇺🇸Seattle, Washington, United States
Diabetes & Glandular Disease Research Associates
🇺🇸San Antonio, Texas, United States