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

ConditionType 1 Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age10-18
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Verapamil oral

    Drug

    active comparator

  • Placebo

    Drug

    placebo comparator

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Verapamil groupActive comparator 1 intervention
Group B: placebo groupPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
24 weeks

Secondary outcomes

1

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

Safety of verapamil during 24 weeks

Time frame
24 weeks
2

HbA1c

HbA1c after 24 weeks compared to baseline

Time frame
24 weeks
3

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

Time in range using freestyle libre2 plus CGM at 24 weeks compared to baseline

Time frame
24 weeks
4

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

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

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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