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Clinical Trial Details

Trial ID: L2117
Source ID: NCT04035031
Associated Drug: Forxiga 10mg
Title: Effects of Dapagliflozin on Hormonal Glucose Homeostasis 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: Area under the curve for glucagon-like peptide I in oral glucose tolerance test clamp, Glucagon-like peptide I will be measured in oral glucose tolerance test clamp following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured., From time-point 0 to 120 minutes during oral glucose tolerance test clamp, measurement every 15 minutes|Area under the curve for glucagon-like peptide I in oral glucose tolerance test clamp, Glucagon-like peptide I will be measured in oral glucose tolerance test clamp following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured., During visit 3 (day 7): From time-point 0 to 120 minutes during oral glucose tolerance test clamp, measurement every 15 minutes|Area under the curve for glucagon-like peptide I in oral glucose tolerance test clamp, Glucagon-like peptide I will be measured in oral glucose tolerance test clamp following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured., During visit 5 (day 31): From time-point 0 to 120 minutes during oral glucose tolerance test clamp, measurement every 15 minutes | Secondary: Area under the curve for glucagon-like peptide I in euglycemic, hyperinsulinemic clamp, Glucagon-like peptide I will be measured in euglycemic, hyperinsulinemic clamp following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured., From time-point 0 to 120 minutes during euglycemic, hyperinsulinemic clamp, measurement every 15 minutes|Area under the curve for ketone body concentrations in euglycemic, hyperinsulinemic clamp following dapagliflozin compared with placebo, Ketone bodies will be measured in euglycemic, hyperinsulinemic clamp following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured., From time-point 0 to 120 minutes during euglycemic, hyperinsulinemic clamp, measurement every 15 minutes|Area under the curve for ketone body concentrations in oral glucose tolerance test clamp following dapagliflozin compared with placebo, Ketone bodies will be measured in oral glucose tolerance test clamp following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured., From time-point 0 to 120 minutes during oral glucose tolerance test clamp, measurement every 15 minutes|Area under the curve for free fatty acids in euglycemic, hyperinsulinemic clamp following dapagliflozin compared with placebo, Free fatty acids will be measured in euglycemic, hyperinsulinemic clamp following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured., From time-point 0 to 120 minutes during euglycemic, hyperinsulinemic clamp, measurement every 15 minutes|Area under the curve for free fatty acids in oral glucose tolerance test clamp following dapagliflozin compared with placebo, Free fatty acids will be measured in oral glucose tolerance test clamp following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured., From time-point 0 to 120 minutes during oral glucose tolerance test clamp, measurement every 15 minutes|Area under the curve for glucagon in euglycemic, hyperinsulinemic clamp following dapagliflozin compared with placebo, Glucagon will be measured in euglycemic, hyperinsulinemic clamp following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured., From time-point 0 to 120 minutes during euglycemic, hyperinsulinemic clamp, measurement every 15 minutes|Area under the curve for glucagon in oral glucose tolerance test clamp following dapagliflozin compared with placebo, Glucagon will be measured in oral glucose tolerance test clamp following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured., From time-point 0 to 120 minutes during oral glucose tolerance test clamp, measurement every 15 minutes|Area under the curve for somatostatin in euglycemic, hyperinsulinemic clamp following dapagliflozin compared with placebo, Somatostatin will be measured in euglycemic, hyperinsulinemic clamp following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured., From time-point 0 to 120 minutes during euglycemic, hyperinsulinemic clamp, measurement every 15 minutes|Area under the curve for somatostatin in oral glucose tolerance test clamp following dapagliflozin compared with placebo, Somatostatin will be measured in oral glucose tolerance test clamp following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured., From time-point 0 to 120 minutes during oral glucose tolerance test clamp, measurement every 15 minutes
Sponsor/Collaborators: Sponsor: Insel Gruppe AG, University Hospital Bern
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 13
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2020-01-09
Completion Date: 2020-11-12
Results First Posted:
Last Update Posted: 2023-03-14
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/NCT04035031