Ignite Creation Date:
2025-12-25 @ 3:05 AM
Ignite Modification Date:
2025-12-26 @ 1:44 AM
Study NCT ID:
NCT03556033
Status:
COMPLETED
Last Update Posted:
2020-03-23
First Post:
2018-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Dapagliflozin on IAH in T1DM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-10-01', 'releaseDate': '2020-09-10'}, {'resetDate': '2020-12-22', 'releaseDate': '2020-11-26'}, {'resetDate': '2021-05-10', 'releaseDate': '2021-04-15'}], 'estimatedResultsFirstSubmitDate': '2020-09-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-20', 'studyFirstSubmitDate': '2018-05-17', 'studyFirstSubmitQcDate': '2018-06-01', 'lastUpdatePostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Inflammatory/atherogenic phenotype of circulating monocytes from the participating patients', 'timeFrame': '45 minutes', 'description': 'measured during hyperinsulinemic hypoglycaemic glucose clamps'}], 'primaryOutcomes': [{'measure': 'Symptom score in response to insulin-induced hypoglycaemia', 'timeFrame': '45 minutes', 'description': 'Symptom scores (autonomic, neuroglycopenic and general) measured during hyperinsulinemic hypoglycaemic glucose clamps. This questionnaire consists of 18 symptoms, which can be scored between 0 (none) to 6 (severe). Total scores range between 0 and 108, the higher the score, the more symptoms patients have during and after hypoglycemia.'}], 'secondaryOutcomes': [{'measure': 'Counterregulatory hormone responses to insulin-induced hypoglycaemia', 'timeFrame': '45 minutes', 'description': '(nor)adrenaline, glucagon, insulin, growth hormone and cortisol responses to hypoglycaemia measured during hyperinsulinemic hypoglycaemic glucose clamps'}, {'measure': 'Time until glycaemic recovery from hypoglycaemia', 'timeFrame': '45 minutes', 'description': 'measured during hyperinsulinemic hypoglycaemic glucose clamps'}, {'measure': 'Maximal glucose excursion post-hypoglycaemia', 'timeFrame': '45 minutes', 'description': 'Maximal glucose level (mmol/l) measured during the 90 minutes after ending the hypoglycaemic phase of the clamp (during restoration of euglycaemia)'}, {'measure': 'Time until glucose peak post-hypoglycaemia', 'timeFrame': '45 minutes', 'description': 'measured during hyperinsulinemic hypoglycaemic glucose clamps'}, {'measure': 'Area under the glucose concentration curve post-hypoglycaemia', 'timeFrame': '45 minutes', 'description': 'measured during hyperinsulinemic hypoglycaemic glucose clamps'}, {'measure': 'Number of severe hypoglycaemic events during follow-up', 'timeFrame': '16 weeks', 'description': 'measured during follow-up'}, {'measure': 'Number of nocturnal hypoglycaemic events during follow-up', 'timeFrame': '16 weeks', 'description': 'measured during follow-up'}, {'measure': 'Number of any hypoglycaemic events during follow-up', 'timeFrame': '16 weeks', 'description': 'measured during follow-up'}, {'measure': 'Time spent under hypoglycaemic conditions measured by glucose sensor monitoring', 'timeFrame': '2 weeks', 'description': 'measured during follow-up'}, {'measure': 'Glucose variability as measured by glucose sensor monitoring', 'timeFrame': '2 weeks', 'description': 'measured during follow-up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1', 'Hypoglycemia', 'Hypoglycemia Unawareness']}, 'descriptionModule': {'briefSummary': 'Approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect hypoglycaemia, a condition referred to as impaired awareness of hypoglycaemia (IAH) that causes a six-fold higher risk of severe, potentially hazardous, hypoglycaemia. IAH is usually the end-result of a process of habituation to recurrent hypoglycaemia that is potentially reversible. Treatment with sodium glucose cotransporter (SGLT)-2 inhibitors (SGLT-2i) in addition to insulin therapy may decrease the incidence of hypoglycaemia in patients with type 1 diabetes. This study will test the hypothesis that treatment with the SGLT-2 inhibitor, dapagliflozin, added to basal-bolus insulin therapy will improve awareness of hypoglycaemia in patients with type 1 diabetes and IAH. In a randomized doubleblind placebo-controlled cross-over trial, patients will be treated for 8 weeks with dapagliflozin (or placebo), after which hypoglycemic symptoms and counterregulatory hormone responses will be examined during a hyperinsulinemic hypoglycemic glucose clamp study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes, disease duration \\>1 year\n* Age \\>18 years, \\<75 years\n* BMI 19-40 kg/m\\^2\n* Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump)\n* Impaired awareness of hypoglycemia as assessed by a score of 3 or more on the modified Dutch translation of the Clarke questionnaire\n* Glycated haemoglobin (HbA1c) ≥42 mmol/mol (6%) and ≤75 mmol/mol (9.0%)\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Treatment with SGLT-2 inhibitors\n* Known intolerance to SGLT-2 inhibitors\n* Treatment with loop diuretics or other anti-hypertensive agents\n* Treatment with glucose-modifying (other than insulin) or immune-modifying agents (e.g. prednisolon)\n* Treatment with pioglitazone\n* Use of statins\n* A history of cardiovascular disease (e.g. myocardial infarction, stroke, heart failure) or hypotension\n* A history of galactose-intolerance, lactase deficiency, glucose-galactose malabsorption\n* History of diabetic ketoacidosis requiring medical intervention within 1 month before screening\n* Admission to the hospital for hyperglycemia or hypoglycemia within 1 month before screening\n* Frequent episodes of severe hypoglycemia within 1 month before screening\n* Laser coagulation for proliferative retinopathy (past 6 months)\n* Proliferative retinopathy\n* Diabetic nephropathy as reflected by an albumin-creatinin ratio ˃ 30 mmol/mg or an estimated glomerular filtration rate (by MDRD) ˂60ml/min/1.73m2\n* History of pancreatitis (acute or chronic) or pancreatic cancer\n* Use of premixed insulin or of long-acting insulin alone\n* Total daily insulin dose requirements \\<20 units unless on pump treatment\n* Pregnancy or unwillingness to undertake measures for birth control'}, 'identificationModule': {'nctId': 'NCT03556033', 'briefTitle': 'Effect of Dapagliflozin on IAH in T1DM', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Effect of the SGLT-2 Inhibitor Dapagliflozin on Impaired Awareness of Hypoglycemia in Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'T1DM_IAH_dapa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg capsule once daily for 8 weeks', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo oral capsule', 'description': 'Placebo matched to dapagliflozin 10 mg capsule once daily for 8 weeks', 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'otherNames': ['Forxiga'], 'description': '8 weeks treatment with dapagliflozin on top of insulin treatment', 'armGroupLabels': ['Dapagliflozin']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': '8 weeks treatment with placebo capsules on top of insulin treatment', 'armGroupLabels': ['Placebo oral capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud university medical center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-09-10', 'type': 'RELEASE'}, {'date': '2020-10-01', 'type': 'RESET'}, {'date': '2020-11-26', 'type': 'RELEASE'}, {'date': '2020-12-22', 'type': 'RESET'}, {'date': '2021-04-15', 'type': 'RELEASE'}, {'date': '2021-05-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Radboud University Medical Center'}}}}