Type 1 Diabetes
Conditions
Keywords
Diabetes Type 1, Diabetes, Insulin-Dependent, Liraglutide, GLP-1 Analogue, Early diagnosis
Brief summary
The main objective of the trial is to study whether daily treatment with liraglutide improves insulin secretion and reduces the requirement of exogenous insulin, and whether liraglutide treatment is tolerable and safe in subjects aged 10-30 years, having an early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT), and treated with insulin.
Interventions
DRUGVictoza® (liraglutide)
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.
DRUGPlacebo
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.
Sponsors
Oulu University Hospital
Tampere University Hospital
Turku University Hospital
Skane University Hospital
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* 10-30 years of age * early diagnosis type 1 diabetes (no symptoms, diagnosis in OGTT) * not pregnant.
Exclusion criteria
* allergic to liraglutide or other ingredients of Victoza® * diabetic ketoacidosis * previous treatment in the last three months with any antidiabetic medication other than insulin * 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 |
|---|---|---|
| Serum C-peptide AUC | From baseline to 26 and 52 weeks | Serum C-peptide area under the curve (AUC) during 2-hour MMTT (mixed-meal tolerance test) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored | From baseline to 26 and 52 weeks | Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored during the 26 weeks treatment period and 26 weeks follow-up period |
| Number of hypoglycemia episodes | From baseline to 26 and 52 weeks | Number of hypoglycemia episodes during the 26 weeks treatment period and 26 weeks follow-up period |
| Frequency of gastrointestinal side effects | 12 months | Frequency of gastrointestinal side effects (diarrhea, nausea, vomiting) during the 26 weeks treatment period and 26 weeks follow-up period |
| Insulin dose | From baseline to 26 and 52 weeks | Insulin dose IU/kg/day |
Countries
Finland, Sweden
Outcome results
None listed