Last updated: October 24, 2023
Sponsor: Population Health Research Institute
Overall Status: Completed
Phase
3
Condition
Diabetes Mellitus, Type 2
Diabetes Prevention
Hypertriglyceridemia
Treatment
insulin degludec
Lifestyle Therapy
IDegLira
Clinical Study ID
NCT03862716
REMITiDegLira
Ages 30-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 loweringdrugs;
- 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.
Exclusion
Exclusion Criteria:
- 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 theupper 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 orvitrectomy;
- history of cardiovascular disease (unless cleared for a moderate intensity exerciseprogram by a specialist) including: i. acute coronary syndrome, hospitalization forunstable angina, myocardial infarction, or revascularization with coronary arterybypass grafting or percutaneous coronary intervention; ii. peripheral vasculardisease, 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, leftbundle branch block, second or third degree atrioventricular block).
- history of any disease requiring frequent intermittent or continuous systemicglucocorticoid 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'sability 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 controlfor the duration of the trial in all females with childbearing potential;
- inability to take insulin degludec, liraglutide or metformin.
Study Design
Total Participants: 159
Treatment Group(s): 4
Primary Treatment: insulin degludec
Phase: 3
Study Start date:
April 23, 2019
Estimated Completion Date:
July 31, 2023
Study Description
Connect with a study center
University of Calgary
Calgary, Alberta T2T 5C7
CanadaSite Not Available
University of Alberta
Edmonton, Alberta T6G 2E1
CanadaSite Not Available
Nova Scotia Health Authority
Halifax, Nova Scotia B3H 1V7
CanadaSite Not Available
McMaster University
Hamilton, Ontario
CanadaSite Not Available
St. Joseph's Hospital
London, Ontario N6A 4V2
CanadaSite Not Available
Western University
London, Ontario N6G 2M1
CanadaSite Not Available
LMC Manna Research
Oakville, Ontario L6M 1M1
CanadaSite Not Available
The Ottawa Hospital
Ottawa, Ontario K1Y 4E9
CanadaSite Not Available
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