The purpose of the study is to determine whether in patients with early type 2 diabetes, a short-term intensive metabolic intervention comprising iGlarLixi, metformin, 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 160 patients with recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 12-week course of treatment with iGlarLixi, metformin 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
161
Dose is titrated to achieve fasting normoglycemia
In those who need additional insulin or who cannot tolerate iGlarLixi, insulin glargine will be used. Dose is titrated to achieve fasting normoglycemia.
Dose is titrated to 2000 mg daily or maximal tolerated dose
University of Calgary
Calgary, Alberta, Canada
LMC
Burlington, Ontario, Canada
Joanne Liutkus
Cambridge, Ontario, Canada
McMaster University
Hamilton, Ontario, Canada
The first occurrence of diabetes relapse
Time frame: 64 weeks of follow-up
Number of participants achieving drug-free diabetes remission
Diabetes remission is defined as HbA1C \< 6.5% off diabetes drugs for at least 12 weeks
Time frame: 24 weeks after randomization
Number of participants achieving drug-free normoglycemia defined as HbA1C < 6.0% off diabetes drugs for at least 12 weeks
Time frame: 24 weeks after randomization
Percentage of weight loss from baseline
(Weight at randomization - weight at 12 weeks)/(weight at randomization)
Time frame: 12 weeks
Change in waist circumference from baseline
(Waist circumference at 12 weeks - weight circumference at randomization)
Time frame: 12 weeks
Glycated hemoglobin (HbA1C)
Expressed in Diabetes Control and Complications Trial (DCCT) units
Time frame: 12 weeks
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Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
St. Joseph's Hospital
London, Ontario, Canada
Western University
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
McGill University
Montreal, Quebec, Canada