Oral Verapamil Among Newly Diagnosed Children and Adolescents With Type 1 Diabetes

NCT07804849 — Phase 2 / Phase 3, Recruiting, 70 participants, Ain Shams University

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Efficay and Safety of Oral Verapamil on Glycemic Metrics and ß-cell Reserve Among Newly Diagnosed Children and Adolescents With Type 1 Diabetes

Registry	NCT07804849
Status	Recruiting
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	70 (Estimated)
Sponsor	Ain Shams University (Other)
Conditions	Type 1 Diabetes Mellitus
Interventions	Verapamil oral, Placebo (Drug)
Dates	start 2026-08-20 (estimated), primary completion 2027-02-20 (estimated), completion 2027-03-20 (estimated), first posted 2026-09-04, last updated 2026-09-04
Locations	1 site in Egypt

-Summary

Type 1 diabetes (T1D) in children involves autoimmune destruction of pancreatic ß- cells, leading to insulin deficiency. Verapamil is an L-type calcium channel blocker that has been used for decades to treat hypertension and certain cardiac conditions. Recent research has revealed its potential as a ß- cell-protective agent. Hence this study will evaluate the effect of once-daily oral verapamil on pancreatic ß- cell reserve , glycemic metrics and daily insulin requirements in children and adolescents with T1D.

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+Arms and interventions

Arm	Type	Interventions	Description
Verapamil group	Active comparator	Drug: Verapamil oral	Children and adolescents with newly diagnosed T1D on add on verapamil
placebo group	Placebo comparator	Drug: Placebo	Children and adolescents with newly diagnosed T1D on add on placebo

Verapamil oral (Drug): active comparator
Placebo (Drug): placebo comparator

+Outcome measures

Primary outcomes

Peak stimulated serum C-peptide concentration after mixed meal tolerance test [24 weeks]: Peak stimulated serum C-peptide concentration after mixed meal tolerance test at 6 months (24 weeks) compared to baseline.

Secondary outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 [24 weeks]: Safety of verapamil during 24 weeks
HbA1c [24 weeks]: HbA1c after 24 weeks compared to baseline
continuous glucose monitoring metrics (time in range) using freestyle libre2 plus CGM [24 weeks]: Time in range using freestyle libre2 plus CGM at 24 weeks compared to baseline
coefficient of variation at 24 weeks compared to baseline using freestyle libre 2 CGM [24 weeks]: CGM coefficient of variation at 24 weeks compared to baseline using freestyle libre 2 CGM

+Eligibility

Sex: All, ages: 10 Years to 18 Years

Inclusion Criteria:

* Children and adolescents aged 10-18 years.
* Newly diagnosed type 1 diabetes mellitus (within 6 weeks of diagnosis, defined as the day of starting insulin therapy).
* Presence of at least two positive islet autoantibody (anti glutamic acid decarboxylase antibodies, anti- tyrosine phosphataseantibodies ,anti- zinc transporter 8 protein antibodies , or anti-insulin antibodies).
* Ability to comply with study procedures.

Exclusion Criteria:

* Previous diagnosis of other endocrine disorders or autoimmune disorder (e.g. autoimmune thyroiditis).
* Current or planned use of medications that might affect glucose metabolism (e.g., corticosteroids, immunomodulators).
* Known allergy or intolerance to verapamil.
* Cardiac conduction abnormalities, heart block, or significant cardiac disease.
* Systolic or diastolic blood pressure < 5th percentile for age and gender.
* Severe hepatic or renal impairment.
* Participation in another interventional clinical trial.
* Inability to follow the protocol for any reason as determined by the investigator.
* Elevated liver enzymes >1.5 × upper limit of normal at screening

+Locations (1)

Facility	City	Country	Status
Ain Shams University	Cairo	Egypt	Recruiting