DRUG
iGlarLixi
Dose is titrated to achieve fasting normoglycemia
Status
Completed
Phase
Phase 3
Enrollment
161
Locations
8
Results
Not posted
Publications
0
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 iGlarLixi, metformin, and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission.
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.
Interventions
DRUG
Dose is titrated to achieve fasting normoglycemia
DRUG
In those who need additional insulin or who cannot tolerate iGlarLixi, insulin glargine will be used. Dose is titrated to achieve fasting normoglycemia.
DRUG
Dose is titrated to 2000 mg daily or maximal tolerated dose
BEHAVIORAL
Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
Timeline
First posted
Apr 26, 2017
Study start
Jun 27, 2017
Primary completion
Jun 30, 2019
Study completion
Sep 30, 2020
Results posted
Not reported
Registry updated
Nov 13, 2020
Outcomes
The first occurrence of diabetes relapse
Time frame · 64 weeks of follow-up
Number of participants achieving drug-free diabetes remission
Time frame · 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
Time frame · 24 weeks after randomization
Percentage of weight loss from baseline
Time frame · 12 weeks
(Weight at randomization - weight at 12 weeks)/(weight at randomization)
Change in waist circumference from baseline
Time frame · 12 weeks
(Waist circumference at 12 weeks - weight circumference at randomization)
Glycated hemoglobin (HbA1C)
Time frame · 12 weeks
Expressed in Diabetes Control and Complications Trial (DCCT) units
Eligibility
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, or \</= 8.5% on 1 glucose-lowering drug, or \</= 8.0% on 2 glucose lowering drugs; 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
Study locations
Canada. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
No PMID-linked publications were present in this registry snapshot.
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