ClinicalTrials.gg
RecruitingNCT07804849Updated Sep 4, 2026

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

A Phase 2/3 interventional study of Verapamil oral and Placebo in Type 1 Diabetes Mellitus, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Ain Shams University · Phase 2/3, Interventional, and Treatment

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Phase
Phase 2/3
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 20 studies in Diabetes Mellitus, Type 1 by Ain Shams University — 3 open to participants now, 3 under way, 3 of them phase 3. Diabetes Mellitus, Type 1 · Ain Shams University.

Planned enrollment
4th of 18
70 · median 60
Started
2026
the only one that year
Phase 2/3
5 of 20
2 open now
Registered
20th of 20
by date

Among the 20 studies in Diabetes Mellitus, Type 1 by Ain Shams University, this one is the 4th largest by planned enrollment of the 18 interventional ones that give a count, is the only one that started in 2026, is one of 5 in phase 2/3, and was the 20th registered.

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

Browse Diabetes Mellitus, Type 1 studies →

Open to participants now

3 of the 20 studies in Diabetes Mellitus, Type 1 by Ain Shams University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 412 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 258 (63%) stop at 75 or younger; 185 take children under 18; 64 take healthy volunteers.

This study: 10 Years to 18 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 20 studies in Diabetes Mellitus, Type 1 by Ain Shams University, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Type 1 Diabetes Mellitus

Keywords

  • Type 1 diabetes
  • Verapamil
  • pancreatic reserve
04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Previous diagnosis of other endocrine disorders or disorder (e.g. autoimmune thyroiditis).
  • Current or planned use of medications that might affect glucose metabolism (e.g., , 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 × at screening
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    Verapamil group

    Children and adolescents with newly diagnosed T1D on add on verapamil

    Drug: Verapamil oral

  • Placebo comparator
    placebo group

    Children and adolescents with newly diagnosed T1D on add on placebo

    Drug: Placebo

Interventions

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Feb 2027, 6 months later.

Of 19 phase 2/3 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2026
First posted
Sep 4, 2026
StartEst.
Aug 20, 2026
Primary completionEst.
Feb 20, 2027
CompletionEst.
Mar 20, 2027
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07804849
Responsible party
Nouran yousef (Dr, Ain Shams University) — Principal investigator
First posted
Sep 4, 2026
Start date
Aug 20, 2026 (estimated)
Primary completion
Feb 20, 2027 (estimated)
Completion
Mar 20, 2027 (estimated)
Last update
Sep 4, 2026

Study contacts

Nouran Salah, MD
Contact
nouranyousef@med.asu.edu.eg
+201116603336

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Verapamil

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