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Clinical Trial Details

Trial ID: L3152
Source ID: NCT03130426
Associated Drug: Iglarlixi
Title: Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi
Acronym: REMIT-iGL
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: iGlarLixi|DRUG: Insulin Glargine|DRUG: Metformin|BEHAVIORAL: Lifestyle therapy
Outcome Measures: Primary: The first occurrence of diabetes relapse, 64 weeks of follow-up | Secondary: Number of participants achieving drug-free diabetes remission, Diabetes remission is defined as HbA1C \< 6.5% off diabetes drugs for at least 12 weeks, 24 weeks after randomization|Number of participants achieving drug-free normoglycemia defined as HbA1C < 6.0% off diabetes drugs for at least 12 weeks, 24 weeks after randomization|Percentage of weight loss from baseline, (Weight at randomization - weight at 12 weeks)/(weight at randomization), 12 weeks|Change in waist circumference from baseline, (Waist circumference at 12 weeks - weight circumference at randomization), 12 weeks|Glycated hemoglobin (HbA1C), Expressed in Diabetes Control and Complications Trial (DCCT) units, 12 weeks
Sponsor/Collaborators: Sponsor: Population Health Research Institute | Collaborators: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 161
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-06-27
Completion Date: 2020-09-30
Results First Posted:
Last Update Posted: 2020-11-13
Locations: University of Calgary, Calgary, Alberta, T2T 5C7, Canada|LMC, Burlington, Ontario, M4G 3E8, Canada|Joanne Liutkus, Cambridge, Ontario, N1R 7L6, Canada|McMaster University, Hamilton, Ontario, L8N 3Z5, Canada|St. Joseph's Hospital, London, Ontario, N6A 4V2, Canada|Western University, London, Ontario, N6G 2M1, Canada|The Ottawa Hospital, Ottawa, Ontario, K1Y 4E9, Canada|McGill University, Montreal, Quebec, H4A 3J1, Canada
URL: https://clinicaltrials.gov/show/NCT03130426