NCT07880769
Verapamil In Preclinical Type 1 Diabetes
Not Yet Recruiting · Phase 2, Phase 3 · Assistance Publique - Hôpitaux de Paris · registry updated 2026-10-22
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- 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.
Exclusion
- 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,