{ "data": { "asOf": "2026-10-30T22:27:23.990Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07880769", "title": "Verapamil In Preclinical Type 1 Diabetes", "scientificTitle": "Preclinical Type 1 Diabetes: the VIP-1 Study", "status": "not_yet_recruiting", "studyType": "interventional", "phase": [ "PHASE2", "PHASE3" ], "conditions": [ "Type 1 Diabetes" ], "interventions": [ { "name": "Verapamil 120 Mg/24 Hours Oral Capsule, Extended Release", "type": "DRUG", "description": "The experimental group will start taking an extended-release formulation of verapamil (once a day).\n\nThe escalation protocol will be adapted as follows:\n\n* 30-34 kg: 120 mg/day up to 48 weeks\n* 35-49 kg: 120 mg/day for 4 weeks, then 240 mg/day up to 48 weeks.\n* ≥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.\n\nThe 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." }, { "name": "Placebo", "type": "OTHER", "description": "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." }, { "name": "blood sampling", "type": "BIOLOGICAL", "description": "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" }, { "name": "EKG and cardiological evaluation", "type": "OTHER", "description": "For safety assesment, EKG and cardiological evaluation will be completed to quantify safety endpoints (heart-rate, blood pressure and conduction period (PR interval)." }, { "name": "Continuous Glucose Monitoring (CGM)", "type": "OTHER", "description": "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." }, { "name": "Urine collection", "type": "OTHER", "description": "C-peptide and creatinine concentrations" } ], "sponsor": { "name": "Assistance Publique - Hôpitaux de Paris", "type": "OTHER" }, "locations": [ { "city": "Paris", "country": "France", "facility": "Hôpital Robert Debré" } ], "outcomes": { "other": [], "primary": [ "Beta-cell function index" ], "secondary": [ "Proinsulin-to-C-peptide ratio", "Chromogranin A/incretin secretion", "disposition index", "T-helper cells (CD4+) /cytotoxic T cells (CD8+)", "Percentage in time", "cardiac arrhythmias", "hypotension" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* age 7 to 45 years;\n* Stage 1 T1D (presence of at least two islet autoantibodies without dysglycemia)\n* body weight ≥30 kg;\n* 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\n* Patient affiliated to a social security scheme (beneficiary or beneficiary's beneficiary);\n* Patients of childbearing age who are sexually active must agree to use a highly effective form of contraception.\n* Inclusion of a single family member\n\nExclusion Criteria:\n\n* People with who previously received a cycle of treatment with teplizumab (anti-CD3)\n* Blood pressure (either systolic or diastolic) \\<5th centile for age, sex, (or systolic \\<100 mmHg in adults) on two out of three measurements.\n* Pulse \\<2nd percentile for age and sex (or\\<50/min in adults) on two out of three measurements;\n* History of vasovagal syncopal episodes related to hypotension over the past 12 months,\n* Abnormal EKG rhythm or arrhythmias known cardiac disease,\n* Arrhythmias unless cleared for study participation by a cardiologist,\n* 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;\n* Use of beta blockers, seizure medications (carbamazepine, phenobarbital, phenytoin), antihypertensive medications, reductase inhibitors, lithium, theophylline, clonidine, or aspirin;\n* Known hypersensitivity to verapamil.\n* Contraindications to verapamil\n* Pregnant women or breastfeeding mothers will not be eligible for the study\n* Patient under guardianship, conservatorship or legally detained\n* Patient participating in another interventional clinical trial investigating a disease modifying treatment (e.g. immunotherapy or others)\n* Adult patients (or legal guardians) whose limited proficiency in French prevents them from receiving fully informed information about the protocol", "maximumAge": "45 Years", "minimumAge": "7 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 50 }, "startDate": "2027-01-01", "completionDate": "2031-03-01", "lastUpdated": "2026-10-22T00:00:00.000Z", "firstPosted": "2026-10-19T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07880769" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07880769", "declaredBy": "clinicaltrials_gov" }, { "idType": "euct", "idValue": "2025-524318-27-00", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07880769", "sourceUrl": "https://clinicaltrials.gov/study/NCT07880769", "sourceStatus": "NOT_YET_RECRUITING", "retrievedAt": "2026-10-28T04:32:00.144Z", "payloadSha256": "db71d22dacaaaf42bce6350dc672b6dee551d31827c54f50b7eed8446b5cec69", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07880769", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07880769", "verifyAt": "https://clinicaltrials.gov/study/NCT07880769", "retrievedAt": "2026-10-28T04:32:00.144Z", "payloadSha256": "db71d22dacaaaf42bce6350dc672b6dee551d31827c54f50b7eed8446b5cec69", "text": "ClinicalTrials.gov, record NCT07880769 (https://clinicaltrials.gov/study/NCT07880769), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07880769, registered in ClinicalTrials.gov, retrieved 2026-10-28. Verify at the source URLs listed; each retrieval is checksummed.", "note": "Only one registry is known to hold this trial. Absence from the others is not evidence it was not registered there." }, "provenanceNote": "Personal contact fields (names, emails, phone numbers, addresses) are stripped from every stored payload. No participant-level data is collected or served." }, "_meta": { "api": "The Last Economy Wire: World Trials API", "version": "1.0", "schemaVersion": "1", "correlationId": "req_HOFjvYjPTnpe", "generatedAt": "2026-10-30T22:27:23.990Z", "documentation": "https://negativeresistance.com/embed", "license": "Free for any use. Attribution appreciated.", "degraded": false, "provenance": { "sources": [ "clinicaltrials_gov" ], "attribution": { "clinicaltrials_gov": "ClinicalTrials.gov: licence: public-domain, https://clinicaltrials.gov/data-api/api-docs" }, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "limitations": [], "provenanceEndpoint": "/api/v1/sources" }, "freshness": { "newestEvidenceAt": null, "lastSyncedAt": { "clinicaltrials_gov": "2026-10-28T04:33:30.663Z" }, "degradedSources": [], "worldwide": false, "maxAgeHours": 65.9, "fromCache": false }, "links": { "discovery": "https://negativeresistance.com/api/v1", "openapi": "https://negativeresistance.com/api/v1/openapi.json", "mcp": "https://negativeresistance.com/api/v1/mcp", "agentCard": "https://negativeresistance.com/.well-known/agent.json", "aiPlugin": "https://negativeresistance.com/.well-known/ai-plugin.json", "sdk": "https://negativeresistance.com/api/v1/sdk", "status": "https://negativeresistance.com/api/v1/status", "provenance": "https://negativeresistance.com/api/v1/sources", "contract": "https://negativeresistance.com/api/v1/contract", "curriculum": "https://negativeresistance.com/api/v1/curriculum", "graph": "https://negativeresistance.com/api/v1/graph", "openQuestions": "https://negativeresistance.com/api/v1/open-questions", "scoreboard": "https://negativeresistance.com/api/v1/scoreboard", "findings": "https://negativeresistance.com/api/v1/findings", "claims": "https://negativeresistance.com/api/v1/claims", "threads": "https://negativeresistance.com/api/v1/threads", "assignment": "https://negativeresistance.com/api/v1/assignment", "changes": "https://negativeresistance.com/api/v1/changes", "hello": "https://negativeresistance.com/api/v1/hello", "errors": "https://negativeresistance.com/api/v1/errors", "webhooks": "https://negativeresistance.com/api/v1/webhooks", "a2a": "https://negativeresistance.com/api/v1/a2a", "deadEnds": "https://negativeresistance.com/api/v1/dead-ends", "decompositions": "https://negativeresistance.com/api/v1/decompositions", "rungs": "https://negativeresistance.com/api/v1/rungs", "methods": "https://negativeresistance.com/api/v1/methods", "reality": "https://negativeresistance.com/api/v1/reality", "council": "https://negativeresistance.com/api/v1/council", "calibration": "https://negativeresistance.com/api/v1/calibration", "freshness": "https://negativeresistance.com/api/v1/freshness", "mission": "https://negativeresistance.com/api/v1/mission", "twin": "https://negativeresistance.com/api/v1/twin", "twinExperiment": "https://negativeresistance.com/api/v1/twin/experiment", "betaCell": "https://negativeresistance.com/api/v1/twin/beta-cell", "patientModel": "https://negativeresistance.com/api/v1/twin/patient-model", "agentCardCanonical": "https://negativeresistance.com/.well-known/agent-card.json", "collaborate": "https://negativeresistance.com/collaborate", "manifesto": "https://negativeresistance.com/about", "documentation": "https://negativeresistance.com/embed", "connect": "https://negativeresistance.com/connect", "llmsTxt": "https://negativeresistance.com/llms.txt", "llmsFullTxt": "https://negativeresistance.com/llms-full.txt" }, "disclaimer": "Research data from public registries and literature; not medical advice." } }