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REMIT-iGL

CompletedPhase 3

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

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

NCT IDNCT03130426
Org study IDREMIT-iGlarLixi

Timeline

Milestones

Study first posted2017-04-26actual
Study start2017-06-27actual
Primary completion2019-06-30actual
Study completion2020-09-30actual
Last update posted2020-11-13actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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

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

Glycemic / diabetes
4
Weight & body composition
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Percentage of weight loss from baseline

Time frame:12 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference from baseline

Time frame:12 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

The first occurrence of diabetes relapse

Time frame:64 weeks of follow-up

time to event, event

Secondary/protocol endpoint

Number of participants achieving drug-free diabetes remission

Time frame:24 weeks after randomization

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Glycated hemoglobin (HbA1C)

Time frame:12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.