Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03862716
- Lead Sponsor
- Population Health Research Institute
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 159
- men and women aged 30-80 years;
- T2D diagnosed within 5 years
- stable T2D drug regimen in the 8 weeks before randomization;
- HbA1c 6.5-9.5% on no glucose lowering drugs, or 6.5%-8.0% on up to 2 glucose lowering drugs;
- body mass index ≥ 23 kg/m2;
- ability and willingness to perform self-monitoring of capillary blood glucose (SMBG);
- willingness to wear a continuous glucose monitor on at least 3 occasions;
- ability and willingness to self-inject IDegLira and insulin;
- provision of informed consent.
- current use of insulin therapy;
- history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance;
- history of end-stage renal disease or eGFR<45 mL/min/1.73 m2 by MDRD formula;
- active liver disease or elevated alanine transferase (ALT) levels ≥ 2.5 times the upper limit of normal at the time of enrolment;
- history or clinical suspicion of pancreatitis or medullary thyroid cancer;
- diagnosis or first degree relative with Multiple Endocrine Neoplasia Type 2 (MEN2);
- history of diabetic retinopathy requiring photocoagulation, injection therapy or vitrectomy;
- history of cardiovascular disease (unless cleared for a moderate intensity exercise program by a specialist) including: i. acute coronary syndrome, hospitalization for unstable angina, myocardial infarction, or revascularization with coronary artery bypass grafting or percutaneous coronary intervention; ii. peripheral vascular disease, valvular heart disease, cardiomyopathy, aortic dissection, tachyarrhythmias, bradyarrhythmias, prior stroke or TIA; iii. prior hospitalization for heart failure; or iv. ECG findings concerning for ischemic heart disease (i.e. pathological Q-waves, ST-segment-T-wave abnormalities in contiguous leads, left anterior hemiblock, left bundle branch block, second or third degree atrioventricular block).
- history of any disease requiring frequent intermittent or continuous systemic glucocorticoid treatment;
- history of bariatric surgery, or planned bariatric surgery in the next 1.5 years;
- history of any major illness with a life expectancy of < 3 years;
- history of injury or any other condition that significantly limits participant's ability to achieve moderate levels of physical activity;
- excessive alcohol intake, acute or chronic;
- currently pregnant, or breastfeeding, or not using a reliable method of birth control for the duration of the trial in all females with childbearing potential;
- inability to take insulin degludec, liraglutide or metformin.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Lifestyle Therapy Drug: IDegLira - sc injection; Drug: metformin - oral administration; Drug: insulin degludec - sc injection; Behavioral: lifestyle therapy, diet and exercise Intervention IDegLira Drug: IDegLira - sc injection; Drug: metformin - oral administration; Drug: insulin degludec - sc injection; Behavioral: lifestyle therapy, diet and exercise Intervention Metformin Drug: IDegLira - sc injection; Drug: metformin - oral administration; Drug: insulin degludec - sc injection; Behavioral: lifestyle therapy, diet and exercise Intervention insulin degludec Drug: IDegLira - sc injection; Drug: metformin - oral administration; Drug: insulin degludec - sc injection; Behavioral: lifestyle therapy, diet and exercise
- Primary Outcome Measures
Name Time Method Proportion of participants achieving drug-free diabetes remission 28 weeks after randomization Drug-free diabetes remission is defined as HbA1C \< 6.5 % off glucose-lowering agents for at least 12 weeks.
- Secondary Outcome Measures
Name Time Method Proportion of participants achieving drug-free diabetes remission 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization Proportion of participants achieving drug-free normoglycemia 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization defined as HbA1C \< 6.0% off glucose-lowering agents for at least 12 weeks.
Proportion of participants achieving drug-free diabetes regression 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization defined as HbA1C \<7.0% off glucose-lowering agents for at least 12 weeks.
Trial Locations
- Locations (8)
University of Alberta
🇨🇦Edmonton, Alberta, Canada
McMaster University
🇨🇦Hamilton, Ontario, Canada
Western University
🇨🇦London, Ontario, Canada
University of Calgary
🇨🇦Calgary, Alberta, Canada
St. Joseph's Hospital
🇨🇦London, Ontario, Canada
Nova Scotia Health Authority
🇨🇦Halifax, Nova Scotia, Canada
LMC Manna Research
🇨🇦Oakville, Ontario, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada