Condition: Type 1 Diabetes · Sponsor: Johnny Ludvigsson
The objective of this trial is first to evaluate safety and then the effect on preservation of residual beta cell function also clinical efficacy by treatment with Verapamil in children with recent onset Type 1 diabetes. Patients are included with the following inclusion criteria; * Informed consent given by patients and caregivers/parents Type 1 diabetes according to the ADA classification within the previous 3 months at the time of screening * Age 4.00 -9.99 years at Diagnosis of Type 1 diabetes * Fasting C-peptide \>0.12 nmol/ml * Elevated levels of any diabetes-related antibody/ies (eg GADA, IAA, IA-2A, ZnT8A ) is/are present. While they are not allowed to participate if they eg have previous cardiac problems or abnormal ECG. The study is a Phase I/II trial, with two parts: A. 6 patients participate in an open controlled study without any placebo with the primary aim to evaluate safety. After a baseline evaluation including ECG, physical examination, mixed Meal Tolerance Test evaluating residual beta cell fuction, these patients will be treated for 12 months with Verapamil 3-6 mg/kg body weight/24 hrs, divided into two daily doses. When these 6 patients have been followed for 6 months, and safety and tolerability is regarded as good, part B will start: In part B the next 30 patients will be randomized 1:1 in a double-blind placebo-controlled study into two arms: 15 patients will receive active treatment for 12 months with Verapamil 3-6 mg/kg body weight/24 hrs divided…
This description comes directly from the study's public registry record.
Johnny Ludvigsson, MD PhD · +46706577234 · Johnny.Ludvigsson@liu.se
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| Pediatric Clinic , Ryhovs hospital | Jönköping, Sweden | Not Yet Recruiting |
| Crown Princess Victoria Children´s Hospital, University Hospital | Linköping, Sweden | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07199946