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Clinical Trial Details

Trial ID: L5727
Source ID: NCT03017352
Associated Drug: Exenatide
Title: Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases
Acronym: MAG1C
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Exenatide|DRUG: Placebos
Outcome Measures: Primary: Change in HbA1c, Change in HbA1c from baseline to end of study (time 6 months), 6 months | Secondary: adverse events (including hypoglycaemic episodes), 6 months|changes in insulin dosage, 6 months|changes in body weight, 6 months|changes in BMI, 6 months|changes in body composition, DXA scan measuring bonemineral density, 6 months|changes in body composition, DXA scan measuring lean mass, 6 months|changes in body composition, DXA scan measuring fat mass, 6 months|changes in fasting plasma glucose, 6 months|changes in post prandial plasma glucose, 6 months|changes in fasting plasma levels of C-peptide, 6 months|Quality of life self reported, Quality of Life Questionaire, 6 months|Treatment satisfaction, Diabetes treatment satisfactory questionnaire status version, 6 months|Treatment satisfaction, Diabetes treatment satisfactory questionnaire change version, 6 months|dietary patterns, Food frequency questionaire three times during the intervention, 6 months|HDL (High Density Lipoprotein), 6 months|LDL (Low Density Lipoprotein), 6 months|VLDL (Very Low Density Lipoprotein), 6 months|total cholesterol, 6 months|triglycerides, 6 months|proBNP (Pro-Brain Natriuretic Peptide), 6 months|hsCRP (High-Sensitivity C-Reactive Protein), 6 months
Sponsor/Collaborators: Sponsor: Filip Krag Knop | Collaborators: Steno Diabetes Center Copenhagen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 108
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2016-12
Completion Date: 2019-06
Results First Posted:
Last Update Posted: 2019-07-10
Locations: Steno Diabetes Center Copenhagen, Gentofte, Capital Region, 2820, Denmark
URL: https://clinicaltrials.gov/show/NCT03017352