VERAPAMIL for Type 1 diabetes

Inclusion criteria

• {"criterion_text":"-Informed consent given by patients and caregivers/parents"}
• {"criterion_text":"-Type 1 diabetes according to the ADA classification within the previous 3 months at the time of screening"}
• {"criterion_text":"-Fasting C-peptide >0.12 nmol/ml"}
• {"criterion_text":"-Elevated levels of any diabetes-related antibody/ies (e.g. GADA, IAA, IA-2A, ZnT8A) is/are present"}
• {"criterion_text":"-\tAge 4.00 - 9.99 years at Diagnosis of Type 1 diabetes"}

Exclusion criteria

• {"criterion_text":"-Cardiac disease/problems, abnormal ECG, or history of abnormal blood pressure"}
• {"criterion_text":"-Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)"}

Primary endpoints

• {"endpoint_text":"-The primary endpoint for part A - Frequency of AE and SAE during the study period (from start of treatment to 18 months).","definition_or_measurement_approach":"Frequency counts of adverse events (AE) and serious adverse events (SAE) occurring from start of treatment to 18 months."}
• {"endpoint_text":"-The primary endpoint for part B - Change in C-peptide (AUCmean 0-120 min) during an MMTT from baseline to month 24.","definition_or_measurement_approach":"Change in C-peptide measured as area under the curve mean (AUCmean) 0-120 minutes during a mixed-meal tolerance test (MMTT) from baseline to month 24."}

Secondary endpoints

• {"endpoint_text":"-The secondary endpoints for part A - Degree of metabolic control measured by HbA1c and TiT measured with Continuous Glucose Monitoring (CGM)","definition_or_measurement_approach":"Metabolic control assessed by Hemoglobin A1c (HbA1c) and Time-in-Target (TiT) measured using Continuous Glucose Monitoring (CGM)."}
• {"endpoint_text":"-The secondary endpoints for part A-Insulin requirement measured as Insulin dose per kg body weight and 24 hours after 12 and 24 months","definition_or_measurement_approach":"Insulin requirement measured as insulin dose per kg body weight and total 24-hour insulin dose at 12 and 24 months."}
• {"endpoint_text":"-The secondary endpoints for part A - Preservation of residual beta cell function (C-peptide) measured by MMTT","definition_or_measurement_approach":"Preservation of residual beta cell function assessed by C-peptide measured during a mixed-meal tolerance test (MMTT)."}
• {"endpoint_text":"-The secondary endpoints for part B -Change in fasting C-peptide value during MMTT from baseline to month 24","definition_or_measurement_approach":"Change in fasting C-peptide measured during MMTT from baseline to month 24."}
• {"endpoint_text":"-The secondary endpoints for part B -\tChange in C-peptide 90 minute value during MMTT from baseline to month 24","definition_or_measurement_approach":"Change in C-peptide value at 90 minutes during MMTT from baseline to month 24."}
• {"endpoint_text":"-The secondary endpoints for part B-Proportion of patients with peak C-peptide > 0.20 nmol/l at month 24.","definition_or_measurement_approach":"Proportion of patients whose peak C-peptide exceeds 0.20 nmol/l at month 24."}
• {"endpoint_text":"-The secondary endpoints for part B- Change in Hemoglobin A1c (HbA1c) between baseline and subsequent visits.","definition_or_measurement_approach":"Change in HbA1c from baseline to subsequent visits."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Change in exogenous insulin dose per kg body weight and 24-hour insulin dose between baseline and subsequent visits."}
• {"endpoint_text":"-The secondary endpoints for part B-Frequency of Serious Adverse Events related to study treatment.","definition_or_measurement_approach":"Frequency counts of serious adverse events (SAEs) judged related to study treatment."}

Sweden

Earliest CTIS Part Ii Submission Date

20-01-2025

Latest Decision Or Authorization Date

11-02-2025

Processing Time Days

22

Number Of Sites

2

Number Of Participants

36

Primary sponsor

Full Name

Linkopings Universitet

Organisation Type

Educational Institution

Country Of Registered Address

Sweden