Clinical trial NCT02617654: Liraglutide Effect on Beta-cell Function in C-peptide Positive Type 1 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent studies show that many Type 1 diabetes patients have remaining endogenous insulin production, albeit at low levels. Finding means to increase this production would be of tremendous interest, since residual C-peptide concentrations \>0.1 nmol/l previously have been shown to markedly lower HbA1c, decrease blood glucose fluctuations and diminish the risk of ketoacidosis. It also substantially reduces the risks of severe hypoglycemic events and late complications. Liraglutide may through its incretin effect directly potentiate beta-cell function, but also holds the potential to be mitogenic for these cells.

The hypothesis of the present trial is that treatment with liraglutide will not only have a direct effect on beta-cell function, which is more or less immediately observed, but also progressively improve C-peptide concentrations over time.


Eligibility criteria: 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

Primary outcomes:
measure: The 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
timeFrame: 52 weeks
Secondary outcomes:
measure: Change in C-peptide between 6 and 52 weeks of study
timeFrame: 52 weeks
measure: Change in C-peptide between after and prior to treatment with liraglutide 1.8 mg
timeFrame: 52 weeks
measure: Change in HbA1c between before and at end of liraglutide (1.8 mg) treatment
timeFrame: 52 weeks
measure: Change in HbA1c between 6 and 52 weeks of study
timeFrame: 52 weeks
measure: Change in HbA1c between after and prior to treatment with liraglutide 1.8 mg
timeFrame: 52 weeks
measure: Change in insulin doses between before and at end of liraglutide (1.8 mg) treatment
timeFrame: 52 weeks
measure: Change in insulin doses between 6 and 52 weeks of study
timeFrame: 52 weeks
measure: Change in insulin doses between after and prior to treatment with liraglutide 1.8 mg
timeFrame: 52 weeks
measure: Change in glucose variability between before and at end of liraglutide (1.8 mg) treatment
timeFrame: 52 weeks
measure: Change in glucose variability between 6 and 52 weeks of study
timeFrame: 52 weeks
measure: Change in glucose variability between after and prior to treatment with liraglutide 1.8 mg
timeFrame: 52 weeks
measure: Change in hypoglycemia frequency between before and at end of liraglutide (1.8 mg) treatment
timeFrame: 52 weeks
measure: Change in hypoglycemia frequency between 6 and 52 weeks of study
timeFrame: 52 weeks
measure: Change in hypoglycemia frequency between after and prior to treatment with liraglutide 1.8 mg
timeFrame: 52 weeks
measure: Change in Quality of Life (QoL) between before and at end of liraglutide (1.8 mg)
timeFrame: 52 weeks
measure: Change in QoL between 6 and 52 weeks of study
timeFrame: 52 weeks
measure: Change in QoL between after and prior to treatment with liraglutide
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University Hospital
name: Per-Ola Carlsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: