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REMIT-iGL
CompletedPhase 3Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi
Lead sponsor
Asset
Lixisenatide
Subcutaneous · GLP-1 agonist
Listed sites
8
Recruiting sites
—
Enrollment
161
actual
Study population
Type 2 diabetes
Key I/E criterion
•HbA1c 6.5-9.5%
Primary endpoint
•First occurrence of diabetes relapse
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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:
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
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsPercentage of weight loss from baseline
Time frame:12 weeks
Body weight, % change
percent change from baseline, improvement
Change in waist circumference from baseline
Time frame:12 weeks
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
4 endpointsThe first occurrence of diabetes relapse
Time frame:64 weeks of follow-up
time to event, event
Number of participants achieving drug-free diabetes remission
Time frame:24 weeks after randomization
threshold achievement, improvement
LOINC 4548-4
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
HbA1c <6.0% achievement
threshold achievement, improvement
LOINC 4548-4
Glycated hemoglobin (HbA1C)
Time frame:12 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.