Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03130426
- 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 iGlarLixi, 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 12-week course of treatment with iGlarLixi, metformin and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 64 weeks (1 year and 3 months). In all participants with HbA1C\<7.3% at the 12 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
- 161
- men and women aged 30-80 years;
- type 2 diabetes mellitus within 5 years of diagnosis;
- stable diabetes drug regimen in the 10 weeks before randomization;
- HbA1c 6.5-9.5% on no glucose lowering drugs, or </= 8.5% on 1 glucose-lowering drug, or </= 8.0% on 2 glucose lowering drugs;
- body mass index >/= 23 kg/m2;
- ability and willingness to perform self-monitoring of capillary blood glucose (SMBG);
- ability and willingness to self-inject iglarlixi; and
- 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 renal dysfunction as evidenced by eGFR<45 mL/min/1.73 m2 by MDRD formula;
- history of lactic acidosis or diabetic ketoacidosis;
- active liver disease or elevated alanine transferase (ALT) levels >\= 2.5 times upper limit of normal at the time of enrolment;
- history or clinical suspicion of pancreatitis or medullary thyroid cancer, or a calcitonin level >/= 20 pg/ml;
- 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 glargine, lixisenatide or metformin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention iGlarLixi Drug: iGlarLixi - sc injection; Drug: metformin - oral administration; Drug: insulin glargine - sc injection; Behavioral: lifestyle therapy, diet and exercise Intervention Lifestyle therapy Drug: iGlarLixi - sc injection; Drug: metformin - oral administration; Drug: insulin glargine - sc injection; Behavioral: lifestyle therapy, diet and exercise Intervention Metformin Drug: iGlarLixi - sc injection; Drug: metformin - oral administration; Drug: insulin glargine - sc injection; Behavioral: lifestyle therapy, diet and exercise Intervention Insulin Glargine Drug: iGlarLixi - sc injection; Drug: metformin - oral administration; Drug: insulin glargine - sc injection; Behavioral: lifestyle therapy, diet and exercise
- Primary Outcome Measures
Name Time Method The first occurrence of diabetes relapse 64 weeks of follow-up
- Secondary Outcome Measures
Name Time Method Number of participants achieving drug-free diabetes remission 24 weeks after randomization Diabetes remission is defined as HbA1C \< 6.5% off diabetes drugs for at least 12 weeks
Number of participants achieving drug-free normoglycemia defined as HbA1C < 6.0% off diabetes drugs for at least 12 weeks 24 weeks after randomization Percentage of weight loss from baseline 12 weeks (Weight at randomization - weight at 12 weeks)/(weight at randomization)
Change in waist circumference from baseline 12 weeks (Waist circumference at 12 weeks - weight circumference at randomization)
Glycated hemoglobin (HbA1C) 12 weeks Expressed in Diabetes Control and Complications Trial (DCCT) units
Trial Locations
- Locations (8)
University of Calgary
🇨🇦Calgary, Alberta, Canada
LMC
🇨🇦Burlington, Ontario, Canada
Joanne Liutkus
🇨🇦Cambridge, Ontario, Canada
McMaster University
🇨🇦Hamilton, Ontario, Canada
St. Joseph's Hospital
🇨🇦London, Ontario, Canada
Western University
🇨🇦London, Ontario, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
McGill University
🇨🇦Montreal, Quebec, Canada
University of Calgary🇨🇦Calgary, Alberta, Canada