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

Inclusion Criteria:

- Informed consent obtained before any trial-related activities. Trial-related
activities are any procedures that are carried out as part of the trial, including
activities to determine suitability for the trial

- Male or female, aged equal to or greater than 18 years at the time of signing
informed consent

- Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit
1 (i.e. screening)

- Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin
pump) treatment 6 months or longer prior to Visit 1 (i.e. screening)

- Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as
judged and documented by the investigator

- HbA1c 7.0-10.0 percent (Diabetes Control and Complications Trial (DCCT)), both
inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53-86
mmol/mol (International Federation of Clinical Chemistry (IFCC))

Exclusion Criteria:

- Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase
IV (DPPIV) inhibitors

- Use of any medication, which in the investigator's opinion could interfere with the
glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) 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 judged
by the investigator

- Uncontrolled/untreated blood pressure at screening (Visit 1) (after resting for 5
minutes) while sitting greater than 160 mmHg for systolic or greater than 100 mmHg
for diastolic (repeated measurement at Visit 2 (prior to performing the trial related
activities) is allowed to exclude white-coat hypertension)

- History of acute or chronic pancreatitis

- Screening (Visit 1) calcitonin value equal to or greater than 50 ng/L