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Clinical Trial Details

Trial ID: L3820
Source ID: NCT04049110
Associated Drug: Forxiga 10mg
Title: Dapagliflozin in Physical Exercise in Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Forxiga 10mg|DRUG: Placebo
Outcome Measures: Primary: Mean Amplitude of Glucose Excursions (MAGE) after physical exercise, MAGE will be calculated via sensor glucose measurements obtained over 72 hours after physical exercise, From completion of physical exercise at day 7 of each intervention period to 72 hours after | Secondary: Area under the curve for glucagon-like peptide I before, during and after physical exercise, Glucagon-like peptide I will be measured at the beginning, during and after physical exercise following each intervention period, From time-point 0 to 120 minutes before, during and after physical exercise session|Area under the curve for glucagon before, during and after physical exercise, Glucagon will be measured at the beginning, during and after physical exercise following each intervention period, From time-point 0 to 120 minutes before, during and after physical exercise session | Other: Area under the curve for ketone bodies before, during and after physical exercise, Ketone bodies will be measured at the beginning, during and after physical exercise, From time-point 0 to 120 minutes before, during and after physical exercise session|Area under the curve for free fatty acids bodies before, during and after physical exercise, Free fatty acids will be measured at the beginning, during and after physical exercise, From time-point 0 to 120 minutes before, during and after physical exercise session|Area under the curve for somatostatin before, during and after physical exercise, Somatostatin will be measured at the beginning, during and after physical exercise, From time-point 0 to 120 minutes before, during and after physical exercise session
Sponsor/Collaborators: Sponsor: Insel Gruppe AG, University Hospital Bern
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 39
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2020-08-25
Completion Date: 2023-05-10
Results First Posted:
Last Update Posted: 2023-08-31
Locations: Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland, Bern, 3010, Switzerland
URL: https://clinicaltrials.gov/show/NCT04049110