Preserving remaining insulin production in children with recent-onset type 1 diabetes using verapamil
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 Verapamil
PHASE1; PHASE2 · Linkoeping University · NCT07199946
This study will try verapamil in children newly diagnosed with type 1 diabetes to see if it helps preserve their remaining insulin production.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 4 Years to 9 Years |
| Sex | All |
| Sponsor | Linkoeping University (other gov) |
| Locations | 2 sites (Jönköping and 1 other locations) |
| Trial ID | NCT07199946 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 4.0–9.99 years diagnosed with type 1 diabetes within the past three months who have fasting C‑peptide >0.12 nmol/ml and at least one positive diabetes autoantibody are ideal candidates.
Not a fit: Patients with prior cardiac problems, abnormal ECG, very low or absent C‑peptide, current use of non-insulin antidiabetic drugs, or recent immunosuppressant exposure are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, verapamil could slow loss of beta-cell function so children keep making more of their own insulin and may need less injected insulin.
How similar studies have performed: Preclinical work and early adult studies suggest verapamil may help preserve beta-cell function, but pediatric data are limited and this approach is still being tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jönköping and 1 other locations
- Pediatric Clinic , Ryhovs hospital — Jönköping, Sweden (NOT_YET_RECRUITING)
- Crown Princess Victoria Children´s Hospital, University Hospital — Linköping, Sweden (RECRUITING)
Study contacts
- Study coordinator: Johnny Ludvigsson, MD PhD
- Email: Johnny.Ludvigsson@liu.se
- Phone: +46706577234
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes, c-peptide, beta cell function, children, Verapamil