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Clinical Trial Details

Trial ID: L6792
Source ID: NCT03556033
Associated Drug: Dapagliflozin
Title: Effect of Dapagliflozin on IAH in T1DM
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1|Hypoglycemia|Hypoglycemia Unawareness
Interventions: DRUG: Dapagliflozin|DRUG: Placebo oral capsule
Outcome Measures: Primary: Symptom score in response to insulin-induced hypoglycaemia, 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., 45 minutes | Secondary: Counterregulatory hormone responses to insulin-induced hypoglycaemia, (nor)adrenaline, glucagon, insulin, growth hormone and cortisol responses to hypoglycaemia measured during hyperinsulinemic hypoglycaemic glucose clamps, 45 minutes|Time until glycaemic recovery from hypoglycaemia, measured during hyperinsulinemic hypoglycaemic glucose clamps, 45 minutes|Maximal glucose excursion post-hypoglycaemia, Maximal glucose level (mmol/l) measured during the 90 minutes after ending the hypoglycaemic phase of the clamp (during restoration of euglycaemia), 45 minutes|Time until glucose peak post-hypoglycaemia, measured during hyperinsulinemic hypoglycaemic glucose clamps, 45 minutes|Area under the glucose concentration curve post-hypoglycaemia, measured during hyperinsulinemic hypoglycaemic glucose clamps, 45 minutes|Number of severe hypoglycaemic events during follow-up, measured during follow-up, 16 weeks|Number of nocturnal hypoglycaemic events during follow-up, measured during follow-up, 16 weeks|Number of any hypoglycaemic events during follow-up, measured during follow-up, 16 weeks|Time spent under hypoglycaemic conditions measured by glucose sensor monitoring, measured during follow-up, 2 weeks|Glucose variability as measured by glucose sensor monitoring, measured during follow-up, 2 weeks | Other: Inflammatory/atherogenic phenotype of circulating monocytes from the participating patients, measured during hyperinsulinemic hypoglycaemic glucose clamps, 45 minutes
Sponsor/Collaborators: Sponsor: Radboud University Medical Center
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 15
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-11-23
Completion Date: 2019-12-20
Results First Posted:
Last Update Posted: 2020-03-23
Locations: Radboud university medical center, Nijmegen, 6500HB, Netherlands
URL: https://clinicaltrials.gov/show/NCT03556033