Status:
RECRUITING
A Phase I/II Trial to Preserve Residual Insulin Secretion in Children With Recent Onset Type 1 Diabetes by Giving Verapamil
Lead Sponsor:
Johnny Ludvigsson
Collaborating Sponsors:
Region Östergötland
Region Jönköping County
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
4-9 years
Phase:
PHASE1
PHASE2
Brief Summary
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 on...
Detailed Description
Type 1 diabetes (T1D) is by far the most common chronic, serious, life-threatening disease in Sweden, and tends to become an extremely serious global problem. Residual insulin secretion is of crucial ...
Eligibility Criteria
Inclusion
- 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.
- Exclusion criteria: • Cardiac disease/problems, abnormal ECG, or history of abnormal blood pressure
- Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
- Continuous treatment with any inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
- Treatment with any oral or injected anti-diabetic medications other than insulin
- A history of anaemia or significantly abnormal haematology results at screening
- Participation in other clinical trials with a new chemical entity within the previous 3 months
- Inability or unwillingness to comply with the provisions of this protocol
- A significant illness other than diabetes within 2 weeks prior to first dosing. However treated celiac disease and hypothyroidism with adequate treatment will be accepted.
- Deemed by the investigator not being able to follow instructions and/or follow the study protocol
Exclusion
Key Trial Info
Start Date :
August 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT07199946
Start Date
August 6 2025
End Date
May 1 2030
Last Update
September 30 2025
Active Locations (2)
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1
Pediatric Clinic , Ryhovs hospital
Jönköping, Sweden
2
Crown Princess Victoria Children´s Hospital, University Hospital
Linköping, Sweden, SE58185