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

• Status: Completed
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether in patients with early type 2 diabetes, a short-term intensive metabolic intervention comprising iGlarLixi, metformin, and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Collaborator: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Lixisenatide; Metformin

Criteria

Inclusion Criteria:

1. men and women aged 30-80 years;

2. type 2 diabetes mellitus within 5 years of diagnosis;

3. stable diabetes drug regimen in the 10 weeks before randomization;

4. HbA1c 6.5-9.5% on no glucose lowering drugs, oror

5. body mass index >/= 23 kg/m2;

6. ability and willingness to perform self-monitoring of capillary blood glucose (SMBG);

7. ability and willingness to self-inject iglarlixi; and

8. provision of informed consent.

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 renal dysfunction as evidenced by eGFR<45 mL/min/1.73 m2 by MDRD formula;

4. history of lactic acidosis or diabetic ketoacidosis;

5. active liver disease or elevated alanine transferase (ALT) levels >\= 2.5 times upper limit of normal at the time of enrolment;

6. history or clinical suspicion of pancreatitis or medullary thyroid cancer, or a calcitonin level >/= 20 pg/ml;

7. 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).

8. history of any disease requiring frequent intermittent or continuous systemic glucocorticoid treatment;

9. history of bariatric surgery, or planned bariatric surgery in the next 1.5 years;

10. history of any major illness with a life expectancy of < 3 years;

11. history of injury or any other condition that significantly limits participant's ability to achieve moderate levels of physical activity;

12. excessive alcohol intake, acute or chronic;

13. 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;

14. inability to take glargine, lixisenatide or metformin