Type 1 Diabetes
Conditions
Keywords
Diabetes Type 1, Diabetes, Insulin-Dependent, Liraglutide, Preclinical Type 1 Diabetes, GLP-1 Analogue
Brief summary
The main objectives of the trial are to study whether daily treatment with liraglutide improves insulin secretion and glucose metabolism, and whether liraglutide treatment is tolerable and safe in subjects with preclinical type 1 diabetes aged 18-30 years.
Interventions
DRUGVictoza®
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.
DRUGPlacebo
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.
Sponsors
Oulu University Hospital
Tampere University Hospital
Turku University Hospital
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* 18-30 years of age * positive for at least 2 biochemical islet autoantibodies * have normal glucose tolerance in OGTT * are not pregnant
Exclusion criteria
* allergic to liraglutide or other ingredients of Victoza® * Type 1 diabetes * diabetic ketoacidosis * previous treatment in the last three months with any antidiabetic medication * impaired liver or kidney function or on dialysis * severe heart failure * severe stomach or gut problem resulting in gastroparesis, or inflammatory bowel disease * past or current history of pancreatitis * serum calcitonin value above normal (\>50 ng/l or ≥3.4pmol/l) * presence of any chronic metabolic, hematologic or malignant disease * obesity BMI ≥30 * pregnant females and females of childbearing potential who are not using adequate contraceptive methods. * breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FPIR (first phase insulin response) | From baseline to 26 and 104 weeks | First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia | From baseline to 26 and 104 weeks | Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia |
| Tolerability | From baseline to 26 and 104 weeks | Tolerability: frequency of side effects, particularly hypoglycaemia and gastrointestinal symptoms |
| Serum C-peptide AUC | From baseline to 26 and 104 weeks | Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test) |
Countries
Finland
Outcome results
None listed