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NCT Number: NCT07804849

Oral Verapamil 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.

Recruiting

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University

Cairo, 11375, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Verapamil oral

Drug

active comparator

Placebo

Drug

placebo comparator

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v6.0

    Time frame: 24 weeks

    Safety of verapamil during 24 weeks

  2. HbA1c

    Time frame: 24 weeks

    HbA1c after 24 weeks compared to baseline

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Nouran Salah, MD

CONTACT

[email protected]

+201116603336

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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