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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
475
Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months
Change in Beta-cell function, measured as stimulated C-peptide secretion 0, 2, 6, 10 and 20 minutes post administration \[area under the curve (AUC), 0-20 minutes\] at baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.
Time frame: Baseline and 24 months
Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7%
The percentage of subjects achieving good glycemic control, i.e. an HbA1c \<7% at study end (Month 25). If HbA1c was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with an HbA1c ≤ 7% at study end.
Time frame: 24 and 25 months
Frequency of Hypoglycemic Events
Total number of days with at least one hypoglycemic event recorded
Time frame: Baseline to 25 Months
Mean Number of Days With at Least One Hypoglycemic Event
Time frame: Baseline to 25 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Los Gatos, California, United States
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
Unnamed facility
DeLand, Florida, United States
Orlando Diabetes & Endocrine Specialists, P.A.
Orlando, Florida, United States
Tallahassee Endocrine Associates
Tallahassee, Florida, United States
...and 65 more locations