Type 1 Diabetes MellitusPhase 2/3NCT07804849
Oral Verapamil Among Newly Diagnosed Children and Adolescents With Type 1 Diabetes
A Phase 2/3 study testing Verapamil oral in people with Type 1 Diabetes Mellitus, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Verapamil oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2026to 20 Mar 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Verapamil oral, Placebo
- Keywords
- Type 1 diabetes, Verapamil, pancreatic reserve
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verapamil oralDrug
active comparator
PlaceboDrug
placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Verapamil group | Active comparator | Children and adolescents with newly diagnosed T1D on add on verapamil Receives: Drug: Verapamil oral |
| placebo group | Placebo comparator | Children and adolescents with newly diagnosed T1D on add on placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (4)
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Safety of verapamil during 24 weeks
Measured: 24 weeks
HbA1c
HbA1c after 24 weeks compared to baseline
Measured: 24 weeks
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
Measured: 24 weeks
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start20 Aug 2026 (estimated)
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran yousef, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804849
- Sponsor's protocol ID
- Verapamil type 1 diabetes
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficay and Safety of Oral Verapamil on Glycemic Metrics and ß-cell Reserve Among Newly Diagnosed Children and Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07804849
- Acronym / sponsor ID
- Verapamil type 1 diabetes
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes, Verapamil, pancreatic reserve
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verapamil group | Active comparator | Drug: Verapamil oralChildren and adolescents with newly diagnosed T1D on add on verapamil |
| placebo group | Placebo comparator | Drug: PlaceboChildren and adolescents with newly diagnosed T1D on add on placebo |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verapamil oralactive comparator | Drug | Verapamil group |
| Placeboplacebo comparator | Drug | placebo group |
Primary outcome
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.
4 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Time frame: 24 weeks
HbA1c
Time frame: 24 weeks
continuous glucose monitoring metrics (time in range) using freestyle libre2 plus CGM
Time frame: 24 weeks
coefficient of variation at 24 weeks compared to baseline using freestyle libre 2 CGM
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Verapamil oral in people with Type 1 Diabetes Mellitus, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nouran Salah, MD (+201116603336, nouranyousef@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak stimulated serum C-peptide concentration after mixed meal tolerance test (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.