Beta-cell function in C-peptide positive type 1 diabetes
Conditions
Interventions
Trade Name: Victoza®
Product Name: Victoza
Pharmaceutical Form: Solution for injection in pre-filled pen
Pharmaceutical form of the placebo: Solution for injection in pre-filled pen
Route of administr
Sponsors
Uppsala University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent for participation of the study, given before undergoing any study-specific procedures. • 18-30 years of age (age interval inclusive of both the ends). Both males and females are eligible for the study • Clinical diagnose of T1D • 5 or more years duration of disease • HbA1C between 45 and 75 mmol/mol • Fasting plasma C-peptide concentration >1.5 pmol/l. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Inability to provide informed consent • Mental incapacity • Unwillingness or language barrier precluding adequate understanding or cooperation • Ongoing or planned pregnancy within the next 12 months • Inadequate or no use of contraceptives • Ongoing breast feeding • Known sight-threatening retinopathy • Creatinine clearance <60 ml/min • Life-threatening cardiovascular disease • History of drug/alcohol abuse • Known or suspected allergy to trial product or related product • Recurrent assisted hypoglycemias • Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin • Uncontrolled hypertension (180/105 mmHg or above) • History of acute or chronic pancreatitis • Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC) • Personal history of non-familial medullary thyroid carcinoma. • Any condition that the investigator or sponsor feel would interfere with trial participation or evaluation of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate 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 (T1D) and residual insulin production.;Secondary Objective: To study changes in metabolic control, Quality of Life (QoL), and humoral and cellular immunity during the year of treatment.;Primary end point(s): The primary efficacy end-point will be ?-change in C-peptide AUC between the MMTT after one year and that after the run-in period.;Timepoint(s) of evaluation of this end point: At one year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.?- change in C-peptide AUC between the MMTT after one year and that after 6 weeks of treatment 2. ?-change in C-peptide AUC between the MMTT three months after cessation of treatment and that after the run-in period 3. ?- change in HbA1c between after one year and after the run-in period. 4. ?- change in HbA1c between after one year and after 6 weeks of treatment 5. ?- change in HbA1c between three months after the cessation of treatment and after the run-in period. 6. ?- change in exogenous insulin doses between after one year and after the run-in period. 7. ?- change in exogenous insulin doses between after one year and after 6 weeks of treatment 8. ?- change in exogenous insulin doses between three months after the cessation of treatment and after the run-in period. 9. ?- change in glucose variability between after one year and after the run-in period. 10. ?- change in glucose variability between after one year and after 6 weeks of treatment 11. ?- change in glucose variability between three months after the cessation of treatment and after the run-in period. 12. ?- change in hypoglycemia frequency (measured plasma glucose levels < 3 mmol/l or assisted hypoglycemia during a one week period) between one year and after the run-in period. 13. ?- change in hypoglycemia frequency (measured plasma glucose levels < 3 mmol/l or assisted hypoglycemia during a one week period) after one year and after 6 weeks of treatment 14. ?- change in hypoglycemia frequency (measured plasma glucose levels < 3 mmol/l or assisted hypoglycemia during a one week period) between three months after the cessation of treatment and after the run-in period. 15. ?- change in assessment of QoL between after one year and after the run-in period. 16. ?- change in assessment of QoL between after one year and after 6 weeks of treatment 17. ?- change in assessment of QoL between three months after the cessation of treatment and after the run-in period. Explorative endpoints | — |
Countries
Sweden
Contacts
Public ContactDir, Unit for Endocrin & Diabetolog
Uppsala University Hospital
Outcome results
None listed