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

NCT ID: NCT03130426

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-27
• Study Completion Date: 2020-09-30

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes; iGlarLixi; Metformin; Insulin; Diet; Exercise; Lifestyle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Drug: iGlarLixi - sc injection; Drug: metformin - oral administration; Drug: insulin glargine - sc injection; Behavioral: lifestyle therapy, diet and exercise

Group Type: EXPERIMENTAL

iGlarLixi

Intervention Type: DRUG

Dose is titrated to achieve fasting normoglycemia

Insulin Glargine

Intervention Type: DRUG

In those who need additional insulin or who cannot tolerate iGlarLixi, insulin glargine will be used. Dose is titrated to achieve fasting normoglycemia.

Metformin

Intervention Type: DRUG

Dose is titrated to 2000 mg daily or maximal tolerated dose

Lifestyle therapy

Intervention Type: BEHAVIORAL

Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving

Standard Care

Standard glycemic care as informed by the current clinical practice guidelines

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

iGlarLixi

Dose is titrated to achieve fasting normoglycemia

Intervention Type: DRUG

Insulin Glargine

In those who need additional insulin or who cannot tolerate iGlarLixi, insulin glargine will be used. Dose is titrated to achieve fasting normoglycemia.

Intervention Type: DRUG

Metformin

Dose is titrated to 2000 mg daily or maximal tolerated dose

Intervention Type: DRUG

Lifestyle therapy

Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving

Intervention Type: BEHAVIORAL

Other Intervention Names

glargine insulin / lixisenatide; Lantus; diet and exercise

Eligibility 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, 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalia McInnes, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Hertzel Gerstein, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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

Countries

Canada

Other Identifiers

REMIT-iGlarLixi

Identifier Type: -

Identifier Source: org_study_id