Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus

In brief

This study will look at the treatment effect of DiaPep277 on preservation of beta-cell function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that changes the way the immune system behaves, stopping its attack on the beta-cells. Adults (\>20 years) with newly diagnosed (\<6 months) type 1 diabetes will be treated with 10 injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.

Key facts

Study ID

NCT01103284

Run by

Andromeda Biotech Ltd.

People needed

475

Starts

2010-04-01

Expected to finish

2014-10-01

Last updated by the study team

2016-05-26

Who can join

Age: 20 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• clinical diagnosis of type 1 diabetes within last 6 months
• Age 20-45 years
• fasting basal C-peptide equal or greater than 0.22 nmol/L, lower than 0.8 nmol/L
• BMI between 17 and 30 at screening

You may not qualify if…

• Significant disease or condition other than type 1 diabetes
• Diabetes-related complications
• Ongoing treatment with immunosuppressive or immunomodulating agents including chronic corticosteroids

Where it is running

• Sutter Gold Medical Foundation — Modesto, California, United States
• San Diego Clinical Trials — San Diego, California, United States
• University of Colorado Hospital - Anschutz Outpatient Pavilion — Aurora, Colorado, United States
• Creekside Endocrine Associates, Inc. — Denver, Colorado, United States
• George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Innovative Medical Research of South Florida Inc. — Aventura, Florida, United States
• Study site — DeLand, Florida, United States
• Orlando Diabetes & Endocrine Specialists, P.A. — Orlando, Florida, United States
• Tallahassee Endocrine Associates — Tallahassee, Florida, United States
• Diabetes and Hormonal Disease Center — Tampa, Florida, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Kentucky Diabetes Endocrinology Center — Lexington, Kentucky, United States
• Washington University — St Louis, Missouri, United States
• Palm Medical Research Center — Las Vegas, Nevada, United States
• Soutwest Clinical Research Center, LLC — Santa Fe, New Mexico, United States
• Mountain Diabetes and Endocrine Center — Ashville, North Carolina, United States
• University of North Carolina Diabetes Care Center — Durham, North Carolina, United States
• The Lindner Research Center, The Christ Hospital — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Legacy Clinical Research & Technology Center — Portland, Oregon, United States
• AM Diabetes & Endocrinology Center — Bartlett, Tennessee, United States
• Research Institute of Dallas — Dallas, Texas, United States
• Cetero Research — San Antonio, Texas, United States
• Northside Internal Medicine Associates, PS — Spokane, Washington, United States
• Study site — Los Gatos, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.