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Clinical Trial Details

Trial ID: L5910
Source ID: NCT02735031
Associated Drug: Exenatide
Title: Exenatide and Impaired Hypoglycaemic Awareness in Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1|Hypoglycemia
Interventions: DRUG: Exenatide|DRUG: Placebo
Outcome Measures: Primary: Symptom score in response to insulin-induced hypoglycaemia, Measured during hyperinsulinemic hypoglycaemic glucose clamps, 30 minutes | Secondary: Adrenaline response to insulin-induced hypoglycaemia, Measured in plasma during hyperinsulinemic hypoglycaemic glucose clamps, 30 minutes|Glucagon response to insulin-induced hypoglycaemia, Measured in plasma during hyperinsulinemic hypoglycaemic glucose clamps, 30 minutes|Time until glycaemic recovery from hypoglycaemia, Measured during hyperinsulinemic hypoglycaemic glucose clamps, 1 hour|Maximal glucose excursion post-hypoglycaemia, Measured during hyperinsulinemic hypoglycaemic glucose clamps, 1 hour|Time until glucose peak post-hypoglycaemia, Measured after hyperinsulinemic hypoglycaemic glucose clamps, 1 hour|Area under the glucose concentration curve post-hypoglycaemia, Measured after hyperinsulinemic hypoglycaemic glucose clamps, 1 hour|Hunger score post-hypoglycaemia, Measured after hyperinsulinemic hypoglycaemic glucose clamps, 1 hour|Carbohydrate requirement after recovery from hypoglycaemia, Measured after hyperinsulinemic hypoglycaemic glucose clamps by showing pictures of various carbohydrate-containing snacks and beverages, 1 hour|Number of severe hypoglycaemic events during follow-up, 16 weeks|Number of nocturnal hypoglycaemic events during follow-up, 16 weeks|Number of any hypoglycaemic events during follow-up, 16 weeks|Number of hypoglycaemic events measured by glucose sensor monitoring, optional (in participants agreeing to wear a continuous glucose sensor for 5 days), 1 week|Time spent under hypoglycaemic conditions measured by glucose sensor monitoring, optional (in participants agreeing to wear a continuous glucose sensor for 5 days), 1 week|Glucose variability as measured by glucose sensor monitoring, optional (in participants agreeing to wear a continuous glucose sensor for 5 days), 1 week | Other: Pulse rate, Measured during hyperinsulinemic hypoglycaemic glucose clamps, 6 weeks|Gastrointestinal side effects, 16 weeks
Sponsor/Collaborators: Sponsor: Radboud University Medical Center | Collaborators: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 10
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-02-21
Completion Date: 2018-04-09
Results First Posted:
Last Update Posted: 2018-04-12
Locations: Radboud university medical centre, Nijmegen, Netherlands
URL: https://clinicaltrials.gov/show/NCT02735031