Preserving remaining insulin production in children with recent-onset type 1 diabetes using verapamil

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I/II trial starts with an open-label safety phase of 6 children and then proceeds to a randomized phase including placebo with up to 30 additional children. Participants are 4.0–9.99 years old, diagnosed within the prior three months, have at least one diabetes autoantibody and measurable fasting C-peptide, and undergo baseline and follow-up mixed-meal tolerance tests (MMTT) with ECG monitoring. The primary outcome is change in C‑peptide AUC over 0–120 minutes from baseline to 24 months; secondary outcomes include fasting and 90‑minute C‑peptide, HbA1c, insulin dose, and safety/tolerability. The trial is conducted at pediatric centers in Jönköping and Linköping, Sweden, with careful cardiac exclusion criteria and regular safety assessments.

Why it matters

Who can join: the full rules

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

Where it's running

• Crown Princess Victoria Children´s Hospital, University Hospital
  Linköping, Sweden Recruiting
• Pediatric Clinic , Ryhovs hospital
  Jönköping, Sweden Not yet recruiting

Study contacts

• Study coordinator: Johnny Ludvigsson, MD PhD
• Email: Johnny.Ludvigsson@liu.se
• Phone: +46706577234

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.