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Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi (REMIT-iGL)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
iGlarLixi
Insulin Glargine
Metformin
Lifestyle therapy
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes, iGlarLixi, Metformin, Insulin, Diet, Exercise, Lifestyle

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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;
  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

Sites / Locations

  • University of Calgary
  • LMC
  • Joanne Liutkus
  • McMaster University
  • St. Joseph's Hospital
  • Western University
  • The Ottawa Hospital
  • McGill University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Standard Care

Arm Description

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

Standard glycemic care as informed by the current clinical practice guidelines

Outcomes

Primary Outcome Measures

The first occurrence of diabetes relapse

Secondary Outcome Measures

Number of participants achieving drug-free diabetes remission
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
Percentage of weight loss from baseline
(Weight at randomization - weight at 12 weeks)/(weight at randomization)
Change in waist circumference from baseline
(Waist circumference at 12 weeks - weight circumference at randomization)
Glycated hemoglobin (HbA1C)
Expressed in Diabetes Control and Complications Trial (DCCT) units

Full Information

First Posted
April 23, 2017
Last Updated
November 10, 2020
Sponsor
Population Health Research Institute
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03130426
Brief Title
Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi
Acronym
REMIT-iGL
Official Title
Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 27, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute
Collaborators
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes, iGlarLixi, Metformin, Insulin, Diet, Exercise, Lifestyle

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Drug: iGlarLixi - sc injection; Drug: metformin - oral administration; Drug: insulin glargine - sc injection; Behavioral: lifestyle therapy, diet and exercise
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard glycemic care as informed by the current clinical practice guidelines
Intervention Type
Drug
Intervention Name(s)
iGlarLixi
Other Intervention Name(s)
glargine insulin / lixisenatide
Intervention Description
Dose is titrated to achieve fasting normoglycemia
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Other Intervention Name(s)
Lantus
Intervention Description
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
Intervention Name(s)
Metformin
Intervention Description
Dose is titrated to 2000 mg daily or maximal tolerated dose
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle therapy
Other Intervention Name(s)
diet and exercise
Intervention Description
Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
Primary Outcome Measure Information:
Title
The first occurrence of diabetes relapse
Time Frame
64 weeks of follow-up
Secondary Outcome Measure Information:
Title
Number of participants achieving drug-free diabetes remission
Description
Diabetes remission is defined as HbA1C < 6.5% off diabetes drugs for at least 12 weeks
Time Frame
24 weeks after randomization
Title
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
Title
Percentage of weight loss from baseline
Description
(Weight at randomization - weight at 12 weeks)/(weight at randomization)
Time Frame
12 weeks
Title
Change in waist circumference from baseline
Description
(Waist circumference at 12 weeks - weight circumference at randomization)
Time Frame
12 weeks
Title
Glycated hemoglobin (HbA1C)
Description
Expressed in Diabetes Control and Complications Trial (DCCT) units
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalia McInnes, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hertzel Gerstein, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2T 5C7
Country
Canada
Facility Name
LMC
City
Burlington
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Joanne Liutkus
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 7L6
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
St. Joseph's Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 2M1
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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