The objective of the trial is to study whether daily treatment with liraglutide improves endogenous insulin secretion, postpones progression to overt Type 1 diabetes, and is tolerable and safe in subjects aged 10-30 years, who are positive for multiple islet autoantibodies and have dysglycemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
13
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months and thereafter follow-up of 6 months.
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months and thereafter follow-up of 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
FPIR (1+3min serum insulin level after iv glucose infusion)
First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test)
Time frame: 12 months
Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
Time frame: 12 months
Tolerability
Tolerability: frequency of side effects, hypoglycaemia and gastrointestinal symptoms in particular
Time frame: 12 months
Serum C-peptide AUC
Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test)
Time frame: 12 months
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