Type 1 DiabetesPhase 2/3VIP-1NCT07880769
Verapamil In Preclinical Type 1 Diabetes
A Phase 2/3 study testing Verapamil 120 Mg/24 Hours Oral Capsule, Extended Release, blood sampling and EKG and cardiological evaluation in people with Type 1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Type 1 diabetes (T1D) is preceded by a presymptomatic phase featured by the presence of islet autoantibodies (aAbs) without (Stage 1) or with (Stage 2) dysglycemia. Clinical investigations targeting Stage 1 or Stage 2 disease have been using the time to clinical disease progression (Stage 3) as primary outcome, with a… Read more about this study
- Who is it for?
- Ages 7 to 45 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Verapamil 120 Mg/24 Hours Oral Capsule, Extended Release, blood sampling and EKG and cardiological evaluation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2027to Mar 2031
- 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 7 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 7 to 45 years;
- Stage 1 T1D (presence of at least two islet autoantibodies without dysglycemia)
- body weight ≥30 kg;
- Obtaining written informed consent signed by the adult subject or by legal guardians in the case of a minor; and the approval of the minor patient
- Patient affiliated to a social security scheme (beneficiary or beneficiary's beneficiary);
- Patients of childbearing age who are sexually active must agree to use a highly effective form of contraception.
Who cannot join
- People with who previously received a cycle of treatment with teplizumab (anti-CD3)
- Blood pressure (either systolic or diastolic) <5th centile for age, sex, (or systolic <100 mmHg in adults) on two out of three measurements.
- Pulse <2nd percentile for age and sex (or<50/min in adults) on two out of three measurements;
- History of vasovagal syncopal episodes related to hypotension over the past 12 months,
- Abnormal EKG rhythm or arrhythmias known cardiac disease,
- Arrhythmias unless cleared for study participation by a cardiologist,
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- Known renal impairment, Duchenne's muscular dystrophy, active Graves' disease or hyperthyroidism and untreated hypothyroidism, AST and/or ALT >3-fold the upper limit of normal;
- Use of beta blockers, seizure medications (carbamazepine, phenobarbital, phenytoin), antihypertensive medications, reductase inhibitors, lithium, theophylline, clonidine, or aspirin;
- Known hypersensitivity to verapamil.
- Contraindications to verapamil
- Pregnant women or breastfeeding mothers will not be eligible for the study
- Patient under guardianship, conservatorship or legally detained
- Patient participating in another interventional clinical trial investigating a disease modifying treatment (e.g. immunotherapy or others)
- Adult patients (or legal guardians) whose limited proficiency in French prevents them from receiving fully informed information about the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Robert Debré
Paris, 75019
Jean-Claude Carel, Phd, +33 1 40 03 41 05, jean-claude.carel@aphp.fr
About this study
Official title: Preclinical Type 1 Diabetes: the VIP-1 Study
Type 1 diabetes (T1D) is preceded by a presymptomatic phase featured by the presence of islet autoantibodies (aAbs) without (Stage 1) or with (Stage 2) dysglycemia. Clinical investigations targeting Stage 1 or Stage 2 disease have been using the time to clinical disease progression (Stage 3) as primary outcome, with a consequent need for relative high numerosity and prolonged follow-up.
Additional hurdles limit the feasibility of disease modifying therapy (DMT) trials for preclinical T1D, including the need for an established screening program able to identify those who might be eligible and the enrolment of relatively large cohorts followed until clinical onset. To overcome these major limitations, our group recently explored the use of mathematical metabolic modelling of beta cell function in the early disease stages of T1D and its ability to quantify the response to treatment. We gathered, for the current proposal, sites with an established screening program for family members of people with T1D. The evidence obtained in our previous experience led to the design of this trial aimed to test the effect of a calcium channel blocker - verapamil - on beta cell function, as quantified through mathematical modelling, in Stage 1 disease. While this drug was previously tested in children and adolescents in the early clinical phases of the disease (Stage 3), it has never been used in Stage 1 disease. Verapamil inhibits beta cell apoptosis in animal models and has been shown to increase C-peptide secretion in adults with recent onset T1D and in youths. We hypothesize that an earlier treatment with verapamil targeting people with Stage 1 disease, whose residual beta cell function is greater than those with Stage 3 disease, may result in prolonged preservation of beta cell functional mass - and, consequently, in delayed clinical progression.
Read the detailed description
The objectives of the study are to evaluate the effect of 48 weeks of verapamil treatment in individuals with stage 1 T1D on beta-cell function, quantified using mathematical metabolic modeling (OMM) during an oral glucose tolerance test (OGTT), and to identify surrogate markers of residual beta-cell function, beta-cell mass, incretin secretion, and treatment response by combining the use of the minimal oral model during the OGTT with continuous glucose monitoring (CGM), C-peptide sampling via DBS, and metabolic and immunological phenotyping. The experimental group will start taking an extended-release formulation of verapamil (once a day). The interventions added for the study areTreatment: Verapamil vs Placebo, multiple timepoints oral glucose tolerance test (OGTT), CGM monitoring, Dried Blood Spot (DBS) C-peptide collection, blood and urine measurements to monitor beta cell function, EKG and cardiological evaluation, blood pressure and heart rate, will be completed to quantify safety endpoints
- Conditions
- Type 1 Diabetes
- Being tested
- Verapamil 120 Mg/24 Hours Oral Capsule, Extended Release, Placebo, blood sampling, EKG and cardiological evaluation, Continuous Glucose Monitoring (CGM)
- Keywords
- Type 1 Diabetes (T1D), preclinical disease, beta-cell function, predictive modeling
- 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 120 Mg/24 Hours Oral Capsule, Extended ReleaseDrug
The experimental group will start taking an extended-release formulation of verapamil (once a day).
The escalation protocol will be adapted as follows:
- 30-34 kg: 120 mg/day up to 48 weeks
- 35-49 kg: 120 mg/day for 4 weeks, then 240 mg/day up to 48 weeks.
- ≥50 kg: 240 mg/day for 4 weeks, then 360 mg/day up to 48 weeks. The dosing regimen adopted in this protocol has been previously reported in a larger study including people in the same age group with new onset clinical T1D. The dose escalation will be based on safety assessment planned at 4 weeks.
The commercial medicine (European speciality) will undergo a change in its labelling and secondary packaging so that the active treatment and placebo units are indistinguishable. The primary packaging will remain unchanged.
PlaceboOther
The placebo in the form of white tablets in blister packs of 10 tablets. The external packaging of the drug and placebo will be similar, and the labelling will include an alphanumeric identifier generated during the randomization process.
blood samplingBiological
OGTT with plasma glucose, insulin, C-peptide, and dry blood spot C-peptide, Chromogranin A, proinsulin, incretin secretion, aspartate aminotransferase(AST), aspartate aminotransferase (ALT), hematocrit, creatinine, complete blood count (CBC), betaHCG (human chorionic gonadotropin) for women of childbearing age. Blood collection for immunophenotyping analysis
EKG and cardiological evaluationOther
For safety assesment, EKG and cardiological evaluation will be completed to quantify safety endpoints (heart-rate, blood pressure and conduction period (PR interval).
Continuous Glucose Monitoring (CGM)Other
In an exploratory analysis, theorical minimal model (OMM) equations will be integrated to calculate insulin sensitivity, as a function of the beta-cell responsivity to glucose and area under CGM signal.
Urine collectionOther
C-peptide and creatinine concentrations
| Study group | Role | What they receive |
|---|---|---|
| verapamil | Experimental | Verapamil 120 mg commercial tablets will be used. As there is no longer a product corresponding to a 120 mg form in France, a product marketed within the European Union will be used.
The escalation protocol will be adapted as follows:
* 30-34 kg: 120 mg/day up to 48 weeks
* 35-49 kg: 120 mg/day for 4 weeks, then 240 mg/day up to 48 weeks.
* ≥50 kg: 240 mg/day for 4 weeks, then 360 mg/day up to 48 weeks. Receives: Drug: Verapamil 120 Mg/24 Hours Oral Capsule, Extended Release; Biological: blood sampling; Other: EKG and cardiological evaluation; Other: Continuous Glucose Monitoring (CGM); Other: Urine collection |
| Placebo | Placebo comparator | "Standard" placebo white tablets (not strictly identical in appearance to the verum), in blister packs of 10, will be similarly labelled and secondary packaged in boxes. Receives: Other: Placebo; Biological: blood sampling; Other: EKG and cardiological evaluation; Other: Continuous Glucose Monitoring (CGM); Other: Urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-cell function index
Beta-cell function - measured by disposition index during OGTT - after 48 weeks of treatment.
Measured: 48 weeks
Secondary outcomes (7)
Proinsulin-to-C-peptide ratio
Proinsulin-to-C-peptide ratio during OGTT
Measured: at baseline, 24 weeks and 48 weeks
Chromogranin A/incretin secretion
study of the association between these markers of beta cell health
Measured: at baseline, 24 weeks and 48 weeks
disposition index
Changes in disposition index components: insulin sensitivity and insulin secretion measured by metabolic modeling
Measured: during 24-week and 48-week OGTTs
T-helper cells (CD4+) /cytotoxic T cells (CD8+)
CD4+/CD8+ T-cell responses of peripheral blood monocytes to type 1 diabetes-associated antigens
Measured: at baseline and 48 weeks
Percentage in time
Percentage change in time spent in glucose ranges (70-140 mg/dL, 70-180 mg/dL) and glucose variability during sensor sessions (CGM)
Measured: at 10 days, 24 weeks and 48 weeks after treatment initiation
cardiac arrhythmias
Assessment of Heart Rhythm Abnormalities
Measured: at baseline, at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after beginning treatment
hypotension
episodes of symptomatic hypotension
Measured: at baseline, 4weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after beginning treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionMar 2031 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Model description
- Randomized placebo-controlled parallel-arm trial. Eligible participants will be randomized (1:1) to receive either verapamil (intervention group) or placebo (control group) for 48 weeks. Participants and investigators will be blinded to the treatment arm.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Francophone pour la Recherche sur le Diabete
- Responsible party
- Sponsor
- Investigators
- Alfonso Galderisi, Phd, Study chair, APHPJean-Claude Carel, Phd, Principal investigator, APHP - hôpital Robert Debré - Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880769
- Sponsor's protocol ID
- APHP250532
- Other IDs
- 2025-524318-27-00, 2025
- Acronym
- VIP-1
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preclinical Type 1 Diabetes: the VIP-1 Study
- ClinicalTrials.gov ID
- NCT07880769
- Acronym / sponsor ID
- VIP-1 / APHP250532
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes (T1D), preclinical disease, beta-cell function, predictive modeling
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation Francophone pour la Recherche sur le Diabete
- Study start
- Jan 2027 (estimated)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 19 Oct 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) is preceded by a presymptomatic phase featured by the presence of islet autoantibodies (aAbs) without (Stage 1) or with (Stage 2) dysglycemia. Clinical investigations targeting Stage 1 or Stage 2 disease have been using the time to clinical disease progression (Stage 3) as primary outcome, with a consequent need for relative high numerosity and prolonged follow-up.
Additional hurdles limit the feasibility of disease modifying therapy (DMT) trials for preclinical T1D, including the need for an established screening program able to identify those who might be eligible and the enrolment of relatively large cohorts followed until clinical onset. To overcome these major limitations, our group recently explored the use of mathematical metabolic modelling of beta cell function in the early disease stages of T1D and its ability to quantify the response to treatment. We gathered, for the current proposal, sites with an established screening program for family members of people with T1D. The evidence obtained in our previous experience led to the design of this trial aimed to test the effect of a calcium channel blocker - verapamil - on beta cell function, as quantified through mathematical modelling, in Stage 1 disease. While this drug was previously tested in children and adolescents in the early clinical phases of the disease (Stage 3), it has never been used in Stage 1 disease. Verapamil inhibits beta cell apoptosis in animal models and has been shown to increase C-peptide secretion in adults with recent onset T1D and in youths. We hypothesize that an earlier treatment with verapamil targeting people with Stage 1 disease, whose residual beta cell function is greater than those with Stage 3 disease, may result in prolonged preservation of beta cell functional mass - and, consequently, in delayed clinical progression.
Detailed description
The objectives of the study are to evaluate the effect of 48 weeks of verapamil treatment in individuals with stage 1 T1D on beta-cell function, quantified using mathematical metabolic modeling (OMM) during an oral glucose tolerance test (OGTT), and to identify surrogate markers of residual beta-cell function, beta-cell mass, incretin secretion, and treatment response by combining the use of the minimal oral model during the OGTT with continuous glucose monitoring (CGM), C-peptide sampling via DBS, and metabolic and immunological phenotyping. The experimental group will start taking an extended-release formulation of verapamil (once a day). The interventions added for the study areTreatment: Verapamil vs Placebo, multiple timepoints oral glucose tolerance test (OGTT), CGM monitoring, Dried Blood Spot (DBS) C-peptide collection, blood and urine measurements to monitor beta cell function, EKG and cardiological evaluation, blood pressure and heart rate, will be completed to quantify safety endpoints
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled parallel-arm trial. Eligible participants will be randomized (1:1) to receive either verapamil (intervention group) or placebo (control group) for 48 weeks. Participants and investigators will be blinded to the treatment arm.
| Arm | Type | Receives |
|---|---|---|
| verapamil | Experimental | Drug: Verapamil 120 Mg/24 Hours Oral Capsule, Extended Release, Biological: blood sampling, Other: EKG and cardiological evaluation, Other: Continuous Glucose Monitoring (CGM), Other: Urine collectionVerapamil 120 mg commercial tablets will be used. As there is no longer a product corresponding to a 120 mg form in France, a product marketed within the European Union will be used. The escalation protocol will be adapted as follows: * 30-34 kg: 120 mg/day up to 48 weeks * 35-49 kg: 120 mg/day for 4 weeks, then 240 mg/day up to 48 weeks. * ≥50 kg: 240 mg/day for 4 weeks, then 360 mg/day up to 48 weeks. |
| Placebo | Placebo comparator | Other: Placebo, Biological: blood sampling, Other: EKG and cardiological evaluation, Other: Continuous Glucose Monitoring (CGM), Other: Urine collection"Standard" placebo white tablets (not strictly identical in appearance to the verum), in blister packs of 10, will be similarly labelled and secondary packaged in boxes. |
Who may qualify
- Ages
- 7 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- age 7 to 45 years;
- Stage 1 T1D (presence of at least two islet autoantibodies without dysglycemia)
- body weight ≥30 kg;
- Obtaining written informed consent signed by the adult subject or by legal guardians in the case of a minor; and the approval of the minor patient
- Patient affiliated to a social security scheme (beneficiary or beneficiary's beneficiary);
Key exclusion criteria (14 listed)
- People with who previously received a cycle of treatment with teplizumab (anti-CD3)
- Blood pressure (either systolic or diastolic) <5th centile for age, sex, (or systolic <100 mmHg in adults) on two out of three measurements.
- Pulse <2nd percentile for age and sex (or<50/min in adults) on two out of three measurements;
- History of vasovagal syncopal episodes related to hypotension over the past 12 months,
- Abnormal EKG rhythm or arrhythmias known cardiac disease,
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 120 Mg/24 Hours Oral Capsule, Extended ReleaseThe experimental group will start taking an extended-release formulation of verapamil (once a day). The escalation protocol will be adapted as follows: * 30-34 kg: 120 mg/day up to 48 weeks * 35-49 kg: 120 mg/day for 4 weeks, then 240 mg/day up to 48 weeks. * ≥50 kg: 240 mg/day for 4 weeks, then 360 mg/day up to 48 weeks. The dosing regimen adopted in this protocol has been previously reported in a larger study including people in the same age group with new onset clinical T1D. The dose escalation will be based on safety assessment planned at 4 weeks. The commercial medicine (European speciality) will undergo a change in its labelling and secondary packaging so that the active treatment and placebo units are indistinguishable. The primary packaging will remain unchanged. | Drug | verapamil |
| PlaceboThe placebo in the form of white tablets in blister packs of 10 tablets. The external packaging of the drug and placebo will be similar, and the labelling will include an alphanumeric identifier generated during the randomization process. | Other | Placebo |
| blood samplingOGTT with plasma glucose, insulin, C-peptide, and dry blood spot C-peptide, Chromogranin A, proinsulin, incretin secretion, aspartate aminotransferase(AST), aspartate aminotransferase (ALT), hematocrit, creatinine, complete blood count (CBC), betaHCG (human chorionic gonadotropin) for women of childbearing age. Blood collection for immunophenotyping analysis | Biological | Placebo, verapamil |
| EKG and cardiological evaluationFor safety assesment, EKG and cardiological evaluation will be completed to quantify safety endpoints (heart-rate, blood pressure and conduction period (PR interval). | Other | Placebo, verapamil |
| Continuous Glucose Monitoring (CGM)In an exploratory analysis, theorical minimal model (OMM) equations will be integrated to calculate insulin sensitivity, as a function of the beta-cell responsivity to glucose and area under CGM signal. | Other | Placebo, verapamil |
| Urine collectionC-peptide and creatinine concentrations | Other | Placebo, verapamil |
Primary outcome
Beta-cell function index
Time frame: 48 weeks
Beta-cell function - measured by disposition index during OGTT - after 48 weeks of treatment.
7 secondary outcomes
Proinsulin-to-C-peptide ratio
Time frame: at baseline, 24 weeks and 48 weeks
Chromogranin A/incretin secretion
Time frame: at baseline, 24 weeks and 48 weeks
disposition index
Time frame: during 24-week and 48-week OGTTs
T-helper cells (CD4+) /cytotoxic T cells (CD8+)
Time frame: at baseline and 48 weeks
Percentage in time
Time frame: at 10 days, 24 weeks and 48 weeks after treatment initiation
cardiac arrhythmias
Time frame: at baseline, at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after beginning treatment
hypotension
Time frame: at baseline, 4weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after beginning treatment
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 22 Oct 2026.
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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.
Alfonso Galderisi, Phd study chair
APHP
Jean-Claude Carel, Phd principal investigator
APHP - hôpital Robert Debré - Paris
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 120 Mg/24 Hours Oral Capsule, Extended Release, blood sampling and EKG and cardiological evaluation in people with Type 1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 22 Oct 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 France. 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 Alfonso Galderisi, PHD (+33 140 03 82 32, alfonso.galderisi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta-cell function index (time frame: 48 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 22 Oct 2026.