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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
13
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.
University of Oulu and Oulu University Hospital, Dept of Children and Adolescents
Oulu, Finland
University of Tampere and Tampere University Hospital
Tampere, Finland
University of Turku and Turku University Hospital
Turku, Finland
Lund University and Skåne University Hospital
Malmö, Sweden
Serum C-peptide AUC
Serum C-peptide area under the curve (AUC) during 2-hour MMTT (mixed-meal tolerance test)
Time frame: From baseline to 26 and 52 weeks
Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored
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
Time frame: From baseline to 26 and 52 weeks
Number of hypoglycemia episodes
Number of hypoglycemia episodes during the 26 weeks treatment period and 26 weeks follow-up period
Time frame: From baseline to 26 and 52 weeks
Frequency of gastrointestinal side effects
Frequency of gastrointestinal side effects (diarrhea, nausea, vomiting) during the 26 weeks treatment period and 26 weeks follow-up period
Time frame: 12 months
Insulin dose
Insulin dose IU/kg/day
Time frame: From baseline to 26 and 52 weeks
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