Patients with type 1 diabetes (T1D) depend on insulin therapy as substitution for the lack of endocrine insulin production due to an autoimmune destruction of beta-cells in the pancreatic inslets. Insulin therapy is based on long lasting basal insulin for controlling fasting plasma glucose, and short lasting mealtime insulin for the postprandial plasma glucose. The long term efficacy of this treatment is measured in glycated haemoglobin A1c (HbA1c) of \<7.0% as the treatment goal. Intensive insulin therapy is associated with side effects such as hypoglycaemia, weight gain, and unwanted exaggerated excursions in PPG. This may ultimately affect treatment compliance. The abovementioned problems associated with insulin treatment in T1D can also be seen in insulin-treated patients with type 2 diabetes (T2D). However, in T2D the combination of insulin with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) has proven effective in reducing the weight gain and insulin dose in insulin-treated patients with T2D without exacerbating the risk of hypoglycaemia. Exenatid is a short lasting GLP-1RA approved for treatment in T2D, and the investigators intend to evaluate it in a randomized, controlled trial as add-on therapy to standard insulin therapy for patients with T1D. The investigators hypothesise that the add-on of exenatide to insulin therapy in patients with T1D will reduce insulin requirements, glycaemic excursions and body weight and improve glycaemic control without increasing the risk of hypoglycaemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
Steno Diabetes Center Copenhagen
Gentofte Municipality, Capital Region, Denmark
Change in HbA1c
Change in HbA1c from baseline to end of study (time 6 months)
Time frame: 6 months
adverse events (including hypoglycaemic episodes)
Time frame: 6 months
changes in insulin dosage
Time frame: 6 months
changes in body weight
Time frame: 6 months
changes in BMI
Time frame: 6 months
changes in body composition
DXA scan measuring bonemineral density
Time frame: 6 months
changes in body composition
DXA scan measuring lean mass
Time frame: 6 months
changes in body composition
DXA scan measuring fat mass
Time frame: 6 months
changes in fasting plasma glucose
Time frame: 6 months
changes in post prandial plasma glucose
Time frame: 6 months
changes in fasting plasma levels of C-peptide
Time frame: 6 months
Quality of life self reported
Quality of Life Questionaire
Time frame: 6 months
Treatment satisfaction
Diabetes treatment satisfactory questionnaire status version
Time frame: 6 months
Treatment satisfaction
Diabetes treatment satisfactory questionnaire change version
Time frame: 6 months
dietary patterns
Food frequency questionaire three times during the intervention
Time frame: 6 months
HDL (High Density Lipoprotein)
Time frame: 6 months
LDL (Low Density Lipoprotein)
Time frame: 6 months
VLDL (Very Low Density Lipoprotein)
Time frame: 6 months
total cholesterol
Time frame: 6 months
triglycerides
Time frame: 6 months
proBNP (Pro-Brain Natriuretic Peptide)
Time frame: 6 months
hsCRP (High-Sensitivity C-Reactive Protein)
Time frame: 6 months
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