The purpose of the study is to determine whether in patients with early type 2 diabetes, a short-term intensive metabolic intervention comprising IDegLira, 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 16-week course of treatment with IDegLira, metformin and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 68 weeks (1 year and 4 months). In all participants with HbA1C\<7.3% at the 16 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
159
Dose is titrated to achieve fasting normoglycemia
In those who need additional insulin or who cannot tolerate IDegLira, insulin degludec will be used. Dose is titrated to achieve fasting normoglycemia.
Dose is titrated to 2000 mg per day or maximal tolerated dose
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
McMaster University
Hamilton, Ontario, Canada
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.
Time frame: 28 weeks after randomization
Proportion of participants achieving drug-free diabetes remission
Time frame: 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.
Time frame: 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.
Time frame: 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization
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Lifestyle intervention includes individualized dietary and exercise advice targeting at least 5% weight loss with frequent visits and coaching for goal reinforcement, behavior modification and problem-solving
St. Joseph's Hospital
London, Ontario, Canada
Western University
London, Ontario, Canada
LMC Manna Research
Oakville, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada