A Phase I/II Double-blind, randomized, placebo-controlled trial to preserve residual insulin secretion in children with recent onset Type 1 diabetes by giving oral Verapamil

Type 1 diabetes

The primary endpoint for part A - Frequency of AE and SAE during the study period (from start of treatment to 18 months)., The primary endpoint for part B - Change in C-peptide (AUCmean 0-120 min) during an MMTT from baseline to month 24.

The secondary endpoints for part A - Degree of metabolic control measured by HbA1c and TiT measured with Continuous Glucose Monitoring (CGM), The secondary endpoints for part A-Insulin requirement measured as Insulin dose per kg body weight and 24 hours after 12 and 24 months, The secondary endpoints for part A - Preservation of residual beta cell function (C-peptide) measured by MMTT, The secondary endpoints for part B -Change in fasting C-peptide value during MMTT from baseline to month 24, The secondary endpoints for part B - Change in C-peptide 90 minute value during MMTT from baseline to month 24, The secondary endpoints for part B-Proportion of patients with peak C-peptide > 0.20 nmol/l at month 24., The secondary endpoints for part B- Change in Hemoglobin A1c (HbA1c) between baseline and subsequent visits., The secondary endpoints for part B-Change in exogenous insulin dose per kg body weight and 24 hours between baseline and subsequent visits when insulin doses are collected., The secondary endpoints for part B-Frequency of Serious Adverse Events related to study treatment.

No related papers found yet.

Sweden