Actively Recruiting
A Phase I/II Double-blind, Randomized, Placebo-controlled Trial to Preserve Residual Insulin Secretion in Children With Recent Onset Type 1 Diabetes Using Verapamil
Led by Johnny Ludvigsson · Updated on 2025-09-30
36
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
Sponsors
J
Johnny Ludvigsson
Lead Sponsor
R
Region Östergötland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Verapamil in preserving residual insulin-producing beta cell function in children aged 4 to 9.99 years with recent onset Type 1 diabetes. This Phase I/II trial focuses on how Verapamil impacts clinical outcomes such as blood glucose control and insulin requirements, addressing a critical need to improve treatment and quality of life for young patients with this serious condition. The trial has two parts: Part A involves 6 children receiving open-label Verapamil at doses of 3-6 mg/kg per day divided into two oral doses for 12 months, primarily to assess safety. Part B will enroll 30 children randomized equally to receive either Verapamil or placebo twice daily for 12 months under double-blind conditions. Evaluations include mixed Meal Tolerance Tests (MMTT) and clinical measures like insulin dose, HbA1c, and continuous glucose monitoring over 24 months. Participants undergo baseline assessments including ECG, physical exams, and MMTT. Follow-ups occur at 12 and 24 months to monitor beta cell function, blood sugar control, insulin use, and safety events. The study carefully tracks treatment effects and tolerability, with the total participation duration spanning two years. This approach aims to identify if Verapamil can help maintain insulin secretion with minimal risks in young children newly diagnosed with Type 1 diabetes.
CONDITIONS
Brief Title
A Phase I/II Trial to Preserve Residual Insulin Secretion in Children With Recent Onset Type 1 Diabetes by Giving Verapamil
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent given by patients and caregivers/parents
- Diagnosis of Type 1 diabetes according to ADA classification within the previous 3 months at screening
- Age between 4.00 and 9.99 years at diagnosis
- Fasting C-peptide greater than 0.12 nmol/ml
- Elevated levels of any diabetes-related antibodies (e.g., GADA, IAA, IA-2A, ZnT8A) present
You will not qualify if you...
- Cardiac disease or problems, abnormal ECG, or history of abnormal blood pressure
- Previous or current treatment with immunosuppressant therapy (topical or inhaled steroids allowed)
- Continuous treatment with any inflammatory drug (sporadic short-term treatment allowed)
- Treatment with any oral or injected anti-diabetic medications other than insulin
- History of anemia or significantly abnormal blood tests at screening
- Participation in other clinical trials with new chemical entities within the past 3 months
- Inability or unwillingness to comply with study protocol
- Significant illness other than diabetes within 2 weeks before first dosing (treated celiac disease and hypothyroidism accepted)
- Deemed unable to follow instructions or study protocol by investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive oral Verapamil or placebo twice daily for 12 months to preserve residual insulin secretion.
Visits at baseline, 12 months, and 24 months for evaluations
Duration - 12 months after treatment
Participants are monitored for safety and efficacy outcomes up to 24 months after starting treatment.
Visits at 12 and 24 months after baseline
Trial Site Locations
Total: 2 locations
1
Pediatric Clinic , Ryhovs hospital
Jönköping, Sweden
Not Yet Recruiting
2
Crown Princess Victoria Children´s Hospital, University Hospital
Linköping, Sweden, SE58185
Actively Recruiting
Research Team
J
Johnny Ludvigsson, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
3
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