Status:
COMPLETED
Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira
Lead Sponsor:
Population Health Research Institute
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-80 years
Phase:
PHASE3
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 ...
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 wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT03862716
Start Date
April 23 2019
End Date
July 31 2023
Last Update
October 25 2023
Active Locations (8)
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1
University of Calgary
Calgary, Alberta, Canada, T2T 5C7
2
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
3
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7
4
McMaster University
Hamilton, Ontario, Canada