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REMITiDegLira
CompletedPhase 3Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira
Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira (REMIT IDegLira): A Randomized Controlled Trial
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
8
Recruiting sites
—
Enrollment
159
actual
Study population
Type 2 diabetes
Key I/E criteria
•BMI ≥23•HbA1c 6.5-9.5%
Primary endpoint
•HbA1c <6.5% achievement
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. T2D diagnosed within 5 years
3. stable T2D drug regimen in the 8 weeks before randomization;
4. HbA1c 6.5-9.5% on no glucose lowering drugs, or 6.5%-8.0% on up to 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. willingness to wear a continuous glucose monitor on at least 3 occasions;
8. ability and willingness to self-inject IDegLira and insulin;
9. 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 eGFR<45 mL/min/1.73 m2 by MDRD formula;
4. active liver disease or elevated alanine transferase (ALT) levels ≥ 2.5 times the upper limit of normal at the time of enrolment;
5. history or clinical suspicion of pancreatitis or medullary thyroid cancer;
6. diagnosis or first degree relative with Multiple Endocrine Neoplasia Type 2 (MEN2);
7. history of diabetic retinopathy requiring photocoagulation, injection therapy or vitrectomy;
8. history of cardiovascular disease (unless cleared for a moderate intensity exercise program by a specialist) including:
9. history of any disease requiring frequent intermittent or continuous systemic glucocorticoid treatment;
10. history of bariatric surgery, or planned bariatric surgery in the next 1.5 years;
11. history of any major illness with a life expectancy of < 3 years;
12. history of injury or any other condition that significantly limits participant's ability to achieve moderate levels of physical activity;
13. excessive alcohol intake, acute or chronic;
14. 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;
15. inability to take insulin degludec, liraglutide or metformin.
Endpoints (14)
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
4 endpointsthe change in weight
Time frame:16, 28, 40, 52 and 68 week visit as well as the overall change
Body weight, absolute change (kg)
change from baseline, improvement
the change in waist circumference
Time frame:16, 28, 40, 52 and 68 week visit as well as the overall change
Waist circumference, change
change from baseline, improvement
the change in hip circumference
Time frame:16, 28, 40, 52 and 68 week visit as well as the overall change
change from baseline, improvement
the change in body mass index
Time frame:16, 28, 40, 52 and 68 week visit as well as the overall change
BMI, change
change from baseline, improvement
Glycemic / diabetes
10 endpointsProportion of participants achieving drug-free diabetes remission
Time frame:28 weeks after randomization
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Proportion of participants achieving drug-free diabetes remission
Time frame:28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization
threshold achievement, improvement
Proportion of participants achieving drug-free normoglycemia
Time frame:28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization
HbA1c <6.0% achievement
threshold achievement, improvement
LOINC 4548-4
Proportion of participants achieving drug-free diabetes regression
Time frame:28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
the time interval from randomization until any glucose lowering drug is restarted or relapse of hyperglycemia
Time frame:Up to week 68
time to event, event
componentsglucose lowering drug restart, hyperglycemia relapse
the time interval from the 16 week visit (i.e. when glucose lowering drugs are to be stopped) until any glucose lowering drug is restarted or relapse of hyperglycemia
Time frame:Up to week 68
time to event, event
the change in HbA1c
Time frame:16, 28, 40, 52 and 68 week visit as well as the overall change
HbA1c, change
change from baseline, improvement
LOINC 4548-4
the change in coefficient of variation over 2 weeks (defined as 4-8 mmol/l), based on up to 2 weeks of Abbott Freestyle Libre ProTM sensor wear
Time frame:from randomization until the 6, 16, 28 and 52 week visit
change from baseline, improvement
the change in interquartile range over 2 weeks (defined as 4-8 mmol/l), based on up to 2 weeks of Abbott Freestyle Libre ProTM sensor wear
Time frame:from randomization until the 6, 16, 28 and 52 week visit
change from baseline, improvement
the change in time range over 2 weeks (defined as 4-8 mmol/l), based on up to 2 weeks of Abbott Freestyle Libre ProTM sensor wear
Time frame:from randomization until the 6, 16, 28 and 52 week visit
CGM time-in-range
change from baseline, improvement
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.