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

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

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07804849

Enrollment

Registered

2026-09-04

Start date

2026-08-20

Completion date

2027-03-20

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetes, Verapamil, pancreatic reserve

Brief 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.

Interventions

DRUGVerapamil oral

active comparator

DRUGPlacebo

placebo comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

10 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Egypt

Contacts

CONTACTNouran Salah, MD

nouranyousef@med.asu.edu.eg+201116603336

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026