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Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi | Clinical Trials | Clareo Health

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

NCT03130426•Population Health Research Institute

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.

Eligibility

Age

30 - 80 years

Sex

ALL

Healthy Volunteers

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;
+4 more criteria

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

Key Dates

Start Date

June 27, 2017

Primary Completion Date

June 30, 2019

Completion Date

September 30, 2020

Last Updated

November 13, 2020

Enrollment

161

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

iGlarLixi

DRUG

Insulin Glargine

DRUG

Metformin

DRUG

Lifestyle therapy

BEHAVIORAL

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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