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

Type 2 Diabetes Mellitus Clinical Trial

— REMIT-iGL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130426
• Other study ID #: REMIT-iGlarLixi
• Status: Completed
• Phase: Phase 3
• Start date: June 27, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2020
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: September 30, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• iGlarLixi
Dose is titrated to achieve fasting normoglycemia
• 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.
• Metformin
Dose is titrated to 2000 mg daily or maximal tolerated dose

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

Locations

Country	Name	City	State
Canada	LMC	Burlington	Ontario
Canada	University of Calgary	Calgary	Alberta
Canada	Joanne Liutkus	Cambridge	Ontario
Canada	McMaster University	Hamilton	Ontario
Canada	St. Joseph's Hospital	London	Ontario
Canada	Western University	London	Ontario
Canada	McGill University	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The first occurrence of diabetes relapse		64 weeks of follow-up
Secondary	Number of participants achieving drug-free diabetes remission	Diabetes remission is defined as HbA1C < 6.5% off diabetes drugs for at least 12 weeks	24 weeks after randomization
Secondary	Number of participants achieving drug-free normoglycemia defined as HbA1C < 6.0% off diabetes drugs for at least 12 weeks		24 weeks after randomization
Secondary	Percentage of weight loss from baseline	(Weight at randomization - weight at 12 weeks)/(weight at randomization)	12 weeks
Secondary	Change in waist circumference from baseline	(Waist circumference at 12 weeks - weight circumference at randomization)	12 weeks
Secondary	Glycated hemoglobin (HbA1C)	Expressed in Diabetes Control and Complications Trial (DCCT) units	12 weeks