The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
457
Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months
Beta-cell function, measured as change in stimulated C-peptide secretion measured 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
Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months
Beta cell function, measured as stimulated C-peptide secretion from 0 to 120 min post administration AUC, at baseline and 24 month measurements in a mixed-meal tolerance test (MMTT). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.
Time frame: Baseline and 24 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rudolfstiftung Hospital
Vienna, Austria
Faculty Hospital
Olomouc, Czechia
Faculty hospital Motol.
Prague, Czechia
IKEM/Diabetes Centre
Prague, Czechia
Pohjois-Karjala projektin tutkimussäätiö
Joensuu, Finland
Tutkimusyksikkö Oulu
Oulu, Finland
Diabetestutkimus
Vantaa, Finland
CHU de Grenoble
Grenoble, France
Hopital Edouard Herriot
Lyon, France
Hopital La Timone
Marseille, France
...and 24 more locations