NCT07804849

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
5mo left

Started Aug 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Aug 2026Mar 2027

First Submitted

Initial submission to the registry

August 18, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 20, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2027

Last Updated

September 4, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 18, 2026

Last Update Submit

September 3, 2026

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetesVerapamilpancreatic reserve

Outcome Measures

Primary Outcomes (1)

  • Peak stimulated serum C-peptide concentration after mixed meal tolerance test

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

    24 weeks

Secondary Outcomes (4)

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

    24 weeks

  • HbA1c

    24 weeks

  • continuous glucose monitoring metrics (time in range) using freestyle libre2 plus CGM

    24 weeks

  • coefficient of variation at 24 weeks compared to baseline using freestyle libre 2 CGM

    24 weeks

Study Arms (2)

Verapamil group

ACTIVE COMPARATOR

Children and adolescents with newly diagnosed T1D on add on verapamil

Drug: Verapamil oral

placebo group

PLACEBO COMPARATOR

Children and adolescents with newly diagnosed T1D on add on placebo

Drug: Placebo

Interventions

Verapamil oralDRUG

active comparator

Verapamil group
PlaceboDRUG

placebo comparator

placebo group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11375, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Verapamil

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic Chemicals

Central Study Contacts

Nouran Salah, MD

CONTACT

+201116603336nouranyousef@med.asu.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 18, 2026

First Posted

September 4, 2026

Study Start

August 20, 2026

Primary Completion (Estimated)

February 20, 2027

Study Completion (Estimated)

March 20, 2027

Last Updated

September 4, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)