The purpose of the study is to determine whether in patients with early type 2 diabetes, a short-term intensive metabolic intervention comprising Forxiga, metformin, basal insulin glargine and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission.
This is a multicentre, open-label, randomized controlled trial in 152 patients with recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 12-week course of treatment with Forxiga, metformin, insulin glargine and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 64 weeks (1 year and 3 months). In all participants with HbA1C\<7.3% at the 12 week visit, glucose-lowering medications will be discontinued and participants will be encouraged to continue with lifestyle modifications and regular glucose monitoring. Participants with HbA1C ≥ 7.3% at this visit or who experience hyperglycemia relapse after stopping drugs will receive standard glycemic management as informed by the current Canadian Diabetes Association clinical practice guidelines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Dose is titrated to achieve fasting normoglycemia
Dose is titrated to 1 g bid or maximal tolerated dose
Dose is titrated to 10 mg po daily or maximal tolerated dose
University of Calgary
Calgary, Alberta, Canada
Health Science Centre
Winnipeg, Manitoba, Canada
McMaster University
Hamilton, Ontario, Canada
St. Joseph's Hospital
London, Ontario, Canada
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.
Time frame: 24 weeks after randomization
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.
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks
Glycated Hemoglobin (HbA1C)
Expressed in Diabetes Control and Complications Trial (DCCT) units
Time frame: 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.
Time frame: During 64 weeks of follow-up
Percentage of Weight Loss From Baseline
(Weight at randomization - weight at 12 weeks)/(weight at randomization)
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Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
Western University
London, Ontario, Canada
LMC
Toronto, Ontario, Canada
St. Michaels's Hospital
Toronto, Ontario, Canada
Time frame: 12 weeks after randomization
Change in Waist Circumference From Baseline
(Waist circumference at 12 weeks - waist circumference at randomization)
Time frame: 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.
Time frame: During 64 weeks of follow-up