Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes

Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test)

Change from baseline in 2-hour PPG increments after 26 weeks of randomised treatment (meal test).

Time frame: Week 0, week 26

Change From Baseline in HbA1c (Post Meal Arm)

Change from baseline in HbA1c (post meal arm) after 26 weeks of randomised treatment.

Time frame: Week 0, week 26

Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

Observed rate of treatment emergent severe or BG confirmed hypoglycaemic events per 100 patient years of exposure (PYE) from baseline until week 26. 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 no later than 1 day after the last day of randomised treatment. Severe or BG confirmed is an episode that is severe according to the American Diabetes Association (ADA) classification (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \<3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.

Time frame: From baseline until week 26

Change From Baseline in Body Weight

Change from baseline in body weight after 26 weeks of randomised treatment.

Time frame: Week 0, week 26

Frequency of Adverse Events

All treatment emergent adverse events (TEAEs) from baseline until 52 weeks of randomised treatment. A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment.