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

September 3, 2026 updated by: Nouran yousef, Ain Shams University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11375
        • Recruiting
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Verapamil group
Children and adolescents with newly diagnosed T1D on add on verapamil
Drug: Verapamil oral
active comparator
Placebo Comparator: placebo group
Children and adolescents with newly diagnosed T1D on add on placebo
Drug: Placebo
placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak stimulated serum C-peptide concentration after mixed meal tolerance test
Time Frame: 24 weeks
Peak stimulated serum C-peptide concentration after mixed meal tolerance test at 6 months (24 weeks) compared to baseline.
24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2026

Primary Completion (Estimated)

February 20, 2027

Study Completion (Estimated)

March 20, 2027

Study Registration Dates

First Submitted

August 18, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 4, 2026

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Verapamil type 1 diabetes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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