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Liraglutide Effect on Beta-cell Function in C-peptide Positive Type 1 Diabetes
A Randomized, Double-blinded Placebo-controlled, Paralleled Designed, Investigator Sponsored Study of the Effect of the GLP-1 Receptor Agonist Liraglutide on Beta-cell Function in C-peptide Positive Type 1 Diabetic Patients
Lead sponsor
Assets
GLP-1 / incretin class catch-all / Liraglutide
Listed sites
1
Recruiting sites
—
Enrollment
18
actual
Study population
Type 1 diabetes
Key I/E criterion
—
Primary endpoint
•C-peptide AUC
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. Written informed consent for participation of the study, given before undergoing any study-specific procedures.
2. 18-30 years of age (age interval inclusive of both the ends). Both males and females are eligible for the study
3. Clinical diagnose of T1D
4. Five or more years duration of disease
5. HbA1C between 45 and 75 mmol/mol
6. Fasting plasma C-peptide concentration >1.5 pmol/l.
Exclusion criteria
1. Inability to provide informed consent
2. Mental incapacity
3. Unwillingness or language barrier precluding adequate understanding or cooperation
4. Ongoing or planned pregnancy within the next 12 months
5. Inadequate or no use of contraceptives
6. Ongoing breast feeding
7. Known sight-threatening retinopathy
8. Creatinine clearance <60 ml/min
9. Life-threatening cardiovascular disease
10. History of drug/alcohol abuse
11. Known or suspected allergy to trial product or related product
12. Recurrent assisted hypoglycemias
13. Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin
14. Uncontrolled hypertension (180/105 mmHg or above)
15. History of acute or chronic pancreatitis
16. Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
17. Personal history of non-familial medullary thyroid carcinoma.
18. Any condition that the investigator or sponsor feel would interfere with trial participation or evaluation of results
Endpoints (18)
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
12 endpointsThe effect of 52 weeks of treatment with liraglutide 1.8 mg/day, compared to placebo, on stimulated C-peptide concentrations in patients with long-standing type 1 diabetes and residual insulin production
Time frame:52 weeks
C-peptide AUC
change from baseline, improvement
Change in C-peptide between 6 and 52 weeks of study
Time frame:52 weeks
C-peptide AUC
change from baseline, improvement
Change in C-peptide between after and prior to treatment with liraglutide 1.8 mg
Time frame:52 weeks
C-peptide AUC
change from baseline, improvement
Change in HbA1c between before and at end of liraglutide (1.8 mg) treatment
Time frame:52 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in HbA1c between 6 and 52 weeks of study
Time frame:52 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in HbA1c between after and prior to treatment with liraglutide 1.8 mg
Time frame:52 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in insulin doses between before and at end of liraglutide (1.8 mg) treatment
Time frame:52 weeks
change from baseline, improvement
Change in insulin doses between 6 and 52 weeks of study
Time frame:52 weeks
change from baseline, improvement
Change in insulin doses between after and prior to treatment with liraglutide 1.8 mg
Time frame:52 weeks
change from baseline, improvement
Change in glucose variability between before and at end of liraglutide (1.8 mg) treatment
Time frame:52 weeks
change from baseline, improvement
Change in glucose variability between 6 and 52 weeks of study
Time frame:52 weeks
change from baseline, improvement
Change in glucose variability between after and prior to treatment with liraglutide 1.8 mg
Time frame:52 weeks
change from baseline, improvement
Patient-reported / QoL
3 endpointsChange in Quality of Life (QoL) between before and at end of liraglutide (1.8 mg)
Time frame:52 weeks
change from baseline, improvement
Change in QoL between 6 and 52 weeks of study
Time frame:52 weeks
change from baseline, improvement
Change in QoL between after and prior to treatment with liraglutide
Time frame:52 weeks
change from baseline, improvement
Safety / tolerability / PK
3 endpointsChange in hypoglycemia frequency between before and at end of liraglutide (1.8 mg) treatment
Time frame:52 weeks
Documented hypoglycemia
change from baseline, event
componentsDocumented hypoglycemia, Severe hypoglycemia
Change in hypoglycemia frequency between 6 and 52 weeks of study
Time frame:52 weeks
Documented hypoglycemia
change from baseline, event
componentsDocumented hypoglycemia, Severe hypoglycemia
Change in hypoglycemia frequency between after and prior to treatment with liraglutide 1.8 mg
Time frame:52 weeks
change from baseline, event
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.