The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes

Inclusion Criteria:

• • Informed consent obtained
• • Type 1 diabetes mellitus for 12 months or longer
• • Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump)treatment for 6 months or longer
• • Stable insulin treatment for the last 3 months prior to Screening, as judged anddocumented by the investigator
• • HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))
• • Ability and willingness to comply with all protocol procedures e.g. correct handlingof trial product, complete trial related questionnaires, diaries, self-monitoring ofplasma glucose, self titration of insulin and attend all scheduled visits

Exclusion Criteria:

• • Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidylpeptidase IV (DPP-4) inhibitors
• • Use of any medication, which in the investigator's opinion could interfere with theglycaemic control or affect the subject's safety.Premix insulin is not allowed
• • Known proliferative retinopathy or maculopathy requiring acute treatment
• • Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judgedby the investigator
• • Uncontrolled/ untreated blood pressure at screening above 160 mmHg for systolic orabove 100 mmHg for diastolic
• • History of acute or chronic pancreatitis
• • Screening calcitonin value equal to or above 50 ng/L
• • Personal or family history of medullary thyroid carcinoma or Multiple EndocrineNeoplasia type 2 (MEN2)
• • Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skincancer or squamous cell skin cancer)