| Trial ID: | L2232 |
| Source ID: | NCT02561130
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Forxiga
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02561130/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: insulin glargine|DRUG: metformin|DRUG: Forxiga|BEHAVIORAL: Lifestyle therapy
|
| Outcome Measures: |
Primary: Number of Participants Achieving Drug-free Diabetes Remission in the Experimental Group Compared to the Control Group, Drug-free diabetes remission is defined as HbA1C \< 6.5 % off glucose-lowering agents for at least 12 weeks., 24 weeks after randomization | Secondary: Number 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., 64 weeks after randomization|Number of Participants Achieving Drug-free HbA1C < 6.0%, Drug-free complete diabetes remission is defined as HbA1C \< 6.0 % off glucose-lowering agents for at least 12 weeks., 24 weeks after randomization|Number of Participants Achieving Diabetes Relapse Without Overt Hyperglycemia Off Diabetes Drugs, Diabetes relapse without overt hyperglycemia is defined as HbA1C 6.5-6.9% off glucose-lowering agents for at least 12 weeks., 24 weeks|Glycated Hemoglobin (HbA1C), Expressed in Diabetes Control and Complications Trial (DCCT) units, 12 weeks after randomization|Number of Participants With Non-severe Symptomatic Hypoglycemic Episodes, Symptomatic hypoglycemic episode is defined as an event with clinical symptoms consistent with hypoglycemia., During 64 weeks of follow-up|Percentage of Weight Loss From Baseline, (Weight at randomization - weight at 12 weeks)/(weight at randomization), 12 weeks after randomization|Change in Waist Circumference From Baseline, (Waist circumference at 12 weeks - waist circumference at randomization), 12 weeks after randomization|Number of Participants With Severe Hypoglycemic Episodes, Severe hypoglycemic episode is defined as an event with clinical symptoms consistent with hypoglycemia in which the participant required the assistance of another person, and one of the following: (i) the event was associated with a documented self-measured or laboratory plasma glucose level \</= 2.0 mmol/L or (ii) the event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration., During 64 weeks of follow-up
|
| Sponsor/Collaborators: |
Sponsor: Population Health Research Institute | Collaborators: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
154
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-12
|
| Completion Date: |
2018-12-31
|
| Results First Posted: |
2020-11-24
|
| Last Update Posted: |
2020-11-24
|
| Locations: |
University of Calgary, Calgary, Alberta, T2T 5C7, Canada|Health Science Centre, Winnipeg, Manitoba, R3E 3P4, Canada|McMaster University, Hamilton, Ontario, L8N 3Z5, Canada|St. Joseph's Hospital, London, Ontario, N6A 4V2, Canada|Western University, London, Ontario, N6G 2M1, Canada|LMC, Toronto, Ontario, M4G 3E8, Canada|St. Michaels's Hospital, Toronto, Ontario, M5C 2T2, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT02561130
|
