{ "data": { "asOf": "2026-10-30T22:27:40.536Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "isrctn": 1 }, "canonicalTrial": { "canonicalId": "ISRCTN95901685", "title": "Aniracetam for prevention of hypoglycemia in type 1 diabetes", "scientificTitle": "Repurposing positive allosteric modulators of glutamate receptors to prevent hypoglycemia in type 1 diabetes: a pilot clinical study", "status": "recruiting", "studyType": "interventional", "phase": [], "conditions": [ "Type 1 Diabetes", "Type 1 diabetes" ], "interventions": [ { "type": "Other", "description": "This is a double blind, crossover, placebo controlled, exploratory physiological study. It is a single site study on 18 participants with T1D, who will be recruited over a 12 month period. The aim is to recruit 9 male and 9 female participants. Each participant will undergo two hypoglycaemic clamp studies, one study will analyse the body's response to Aniracetam 1500mg, the standard dose used in Europe, given during the clamp. The second study, 4-6 weeks later, will analyse the same parameters using the identical placebo. An NHS clinical trials pharmacist will be unblinded and therefore keep a record of which intervention each participant has had." } ], "sponsor": null, "locations": [ { "country": "United Kingdom" }, { "country": "Scotland" } ], "outcomes": { "other": [], "primary": [], "secondary": [] }, "eligibility": { "gender": "All", "exclusion": "1. Proliferative retinopathy\n2. History of diabetic ketoacidosis in the preceding 6 months\n3. Severe hypoglycaemic episode requiring external assistance in the preceding 6 months\n4. History of haemophilia, cystic fibrosis, pancreatic disease or complete pancreatectomy, ischaemic heart disease, cardiac arrhythmia, epilepsy or hypoglycaemia induced seizure\n5. History of severe reaction or allergy to adhesive necessary to this study\n6. Unable to adhere to study timetable\n7. Unable to give informed consent\n8. Pregnancy or planning pregnancy. We will perform a pregnancy test on all eligible participants at baseline\n9. Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas). These may lower insulin requirements and predispose to diabetic ketoacidosis\n10. Hypothyroidism\n11. Concurrent use of medication that may affect blood glucose such as SSRIs\n12. Inability to understand or speak English. Time is of the essence during the clamp procedure, there is no time for translation\n13. A condition, which in the opinion of the investigator, would put the patient or study at risk", "inclusion": "Current inclusion criteria as of 27/10/2026:\n1. Participants with T1D with C-peptide levels less than 50 pmol/l\n2. Age 21-65 years\n3. T1D for 5 years or more\n\nPrevious inclusion criteria:\n1. Participants with T1D with C-peptide levels less than 100 pmol/L\n2. Age 21-65 years\n3. T1D for 5 years or more", "lowerAgeLimit": null, "upperAgeLimit": null, "healthyVolunteersAllowed": "false" }, "enrollment": { "final": "0", "target": "18" }, "startDate": "2025-07-01", "completionDate": "2027-12-01", "lastUpdated": "2026-10-27T15:21:29.231Z", "firstPosted": "2025-04-22T07:15:33.416Z", "resultsAvailable": false, "sourceRegistries": [ "isrctn" ], "sourceUrls": [ "https://www.isrctn.com/ISRCTN95901685" ] }, "identifiers": [ { "idType": "isrctn", "idValue": "ISRCTN95901685", "declaredBy": "isrctn" } ], "sourceRecords": [ { "registry": "isrctn", "registryName": "ISRCTN", "license": "public", "sourceId": "ISRCTN95901685", "sourceUrl": "https://www.isrctn.com/ISRCTN95901685", "sourceStatus": "recruitmentStart=2025-07-01T00:00:00.000Z;recruitmentEnd=2027-07-01T00:00:00.000Z;overallEnd=2027-12-01T00:00:00.000Z", "retrievedAt": "2026-10-28T04:34:04.660Z", "payloadSha256": "a99baa3e93d3ba7690f5385dea76af347fdd8cf3f823e861d599a7dfc018b8e6", "piiRedacted": true } ], "citation": { "canonicalId": "ISRCTN95901685", "sources": [ { "registry": "isrctn", "registryName": "ISRCTN", "license": "public", "sourceId": "ISRCTN95901685", "verifyAt": "https://www.isrctn.com/ISRCTN95901685", "retrievedAt": "2026-10-28T04:34:04.660Z", "payloadSha256": "a99baa3e93d3ba7690f5385dea76af347fdd8cf3f823e861d599a7dfc018b8e6", "text": "ISRCTN, record ISRCTN95901685 (https://www.isrctn.com/ISRCTN95901685), retrieved 2026-10-28, licence: public." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial ISRCTN95901685, registered in ISRCTN, retrieved 2026-10-28. 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