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Clinical Trial Details

Trial ID: L4182
Source ID: NCT03862716
Associated Drug: Ideglira
Title: Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira
Acronym: REMITiDegLira
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: IDegLira|DRUG: insulin degludec|DRUG: Metformin|BEHAVIORAL: Lifestyle Therapy
Outcome Measures: Primary: Proportion of participants achieving drug-free diabetes remission, Drug-free diabetes remission is defined as HbA1C \< 6.5 % off glucose-lowering agents for at least 12 weeks., 28 weeks after randomization | Secondary: Proportion of participants achieving drug-free diabetes remission, 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization|Proportion of participants achieving drug-free normoglycemia, defined as HbA1C \< 6.0% off glucose-lowering agents for at least 12 weeks., 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization|Proportion of participants achieving drug-free diabetes regression, defined as HbA1C \<7.0% off glucose-lowering agents for at least 12 weeks., 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization | Other: the time interval from randomization until any glucose lowering drug is restarted or relapse of hyperglycemia, Up to week 68|the time interval from the 16 week visit (i.e. when glucose lowering drugs are to be stopped) until any glucose lowering drug is restarted or relapse of hyperglycemia, Up to week 68|the change in HbA1c, 16, 28, 40, 52 and 68 week visit as well as the overall change|the change in weight, 16, 28, 40, 52 and 68 week visit as well as the overall change|the change in waist circumference, 16, 28, 40, 52 and 68 week visit as well as the overall change|the change in hip circumference, 16, 28, 40, 52 and 68 week visit as well as the overall change|the change in body mass index, 16, 28, 40, 52 and 68 week visit as well as the overall change|the change in coefficient of variation over 2 weeks (defined as 4-8 mmol/l), based on up to 2 weeks of Abbott Freestyle Libre ProTM sensor wear, from randomization until the 6, 16, 28 and 52 week visit|the change in interquartile range over 2 weeks (defined as 4-8 mmol/l), based on up to 2 weeks of Abbott Freestyle Libre ProTM sensor wear, from randomization until the 6, 16, 28 and 52 week visit|the change in time range over 2 weeks (defined as 4-8 mmol/l), based on up to 2 weeks of Abbott Freestyle Libre ProTM sensor wear, from randomization until the 6, 16, 28 and 52 week visit
Sponsor/Collaborators: Sponsor: Population Health Research Institute | Collaborators: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 159
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-04-23
Completion Date: 2023-07-31
Results First Posted:
Last Update Posted: 2023-10-25
Locations: University of Calgary, Calgary, Alberta, T2T 5C7, Canada|University of Alberta, Edmonton, Alberta, T6G 2E1, Canada|Nova Scotia Health Authority, Halifax, Nova Scotia, B3H 1V7, Canada|McMaster University, Hamilton, Ontario, Canada|St. Joseph's Hospital, London, Ontario, N6A 4V2, Canada|Western University, London, Ontario, N6G 2M1, Canada|LMC Manna Research, Oakville, Ontario, L6M 1M1, Canada|The Ottawa Hospital, Ottawa, Ontario, K1Y 4E9, Canada
URL: https://clinicaltrials.gov/show/NCT03862716