Efficacy and Safety of Liraglutide in Subjects With Type 1 Diabetes Undergoing Islet Cell Transplantation

Number of Hypoglycaemic Episodes

A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episodes were categorised either as minor (PG\<3.1 mmol/L \[56 mg/dL\]) or severe (subject unable to treat himself/herself).

Time frame: During week 0 to week 52

Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events

Proportion of subjects with HbA1c below or equal to 6.5% at week 52 that were free from severe hypoglycaemic events

Time frame: From week 0 to week 52 after initial transplantation

Proportion of Insulin-Independent Subjects

Proportion of insulin-independent subjects among all randomised subjects who had one or more transplantations after randomisation

Time frame: At 52 weeks after initial transplantation

Change in Islet Cell Yield During Culture

Change in islet cell yield from pre-culture to post-culture

Time frame: From 0 hours pre-culture to 24 hours to 72 hours

Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS)

Change from baseline in glucose level variability and hypoglycaemia at baseline, weekly during liraglutide dose escalation, at 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo)