Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira

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

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. men and women aged 30-80 years;
  2. T2D diagnosed within 5 years
  3. stable T2D drug regimen in the 8 weeks before randomization;
  4. HbA1c 6.5-9.5% on no glucose lowering drugs, or 6.5%-8.0% on up to 2 glucose loweringdrugs;
  5. body mass index ≥ 23 kg/m2;
  6. ability and willingness to perform self-monitoring of capillary blood glucose (SMBG);
  7. willingness to wear a continuous glucose monitor on at least 3 occasions;
  8. ability and willingness to self-inject IDegLira and insulin;
  9. provision of informed consent.

Exclusion

Exclusion Criteria:

  1. current use of insulin therapy;
  2. history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance;
  3. history of end-stage renal disease or eGFR<45 mL/min/1.73 m2 by MDRD formula;
  4. active liver disease or elevated alanine transferase (ALT) levels ≥ 2.5 times theupper limit of normal at the time of enrolment;
  5. history or clinical suspicion of pancreatitis or medullary thyroid cancer;
  6. diagnosis or first degree relative with Multiple Endocrine Neoplasia Type 2 (MEN2);
  7. history of diabetic retinopathy requiring photocoagulation, injection therapy orvitrectomy;
  8. 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).
  9. history of any disease requiring frequent intermittent or continuous systemicglucocorticoid treatment;
  10. history of bariatric surgery, or planned bariatric surgery in the next 1.5 years;
  11. history of any major illness with a life expectancy of < 3 years;
  12. history of injury or any other condition that significantly limits participant'sability to achieve moderate levels of physical activity;
  13. excessive alcohol intake, acute or chronic;
  14. currently pregnant, or breastfeeding, or not using a reliable method of birth controlfor the duration of the trial in all females with childbearing potential;
  15. 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

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.

Connect with a study center

  • University of Calgary

    Calgary, Alberta T2T 5C7
    Canada

    Site Not Available

  • University of Alberta

    Edmonton, Alberta T6G 2E1
    Canada

    Site Not Available

  • Nova Scotia Health Authority

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • McMaster University

    Hamilton, Ontario
    Canada

    Site Not Available

  • St. Joseph's Hospital

    London, Ontario N6A 4V2
    Canada

    Site Not Available

  • Western University

    London, Ontario N6G 2M1
    Canada

    Site Not Available

  • LMC Manna Research

    Oakville, Ontario L6M 1M1
    Canada

    Site Not Available

  • The Ottawa Hospital

    Ottawa, Ontario K1Y 4E9
    Canada

    Site Not Available

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