A Phase 2/3 interventional study of Verapamil 120 Mg/24 Hours Oral Capsule, Extended Release and Placebo in Type 1 Diabetes, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 7 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2/3, Interventional, and Treatment
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.
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
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
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.
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
"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.
Other: Placebo · Biological: blood sampling · Other: EKG and cardiological evaluation · Other: Continuous Glucose Monitoring (CGM) · Other: Urine collection
Drug page: Verapamil
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.
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.
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
For safety assesment, EKG and cardiological evaluation will be completed to quantify safety endpoints (heart-rate, blood pressure and conduction period (PR interval).
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.
C-peptide and creatinine concentrations
Beta-cell function index
Beta-cell function - measured by disposition index during OGTT - after 48 weeks of treatment.
Time frame: 48 weeks
Proinsulin-to-C-peptide ratio
Proinsulin-to-C-peptide ratio during OGTT
Time frame: at baseline, 24 weeks and 48 weeks
Chromogranin A/incretin secretion
study of the association between these markers of beta cell health
Time frame: at baseline, 24 weeks and 48 weeks
disposition index
Changes in disposition index components: insulin sensitivity and insulin secretion measured by metabolic modeling
Time frame: 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
Time frame: 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)
Time frame: at 10 days, 24 weeks and 48 weeks after treatment initiation
cardiac arrhythmias
Assessment of Heart Rhythm Abnormalities
Time frame: at baseline, at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after beginning treatment
hypotension
episodes of symptomatic hypotension
Time frame: at baseline, 4weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after beginning treatment
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Verapamil
Assistance Publique - Hôpitaux de Paris →