Endpoints

The primary endpoint was the rate of overall symptomatic hypoglycaemic events (defined as severe [an event requiring third-party assistance [28]] or confirmed blood glucose <3.1 mmol/l [with symptoms]) during the maintenance period. Secondary confirmatory hypoglycaemia endpoints included the rate of nocturnal symptomatic hypoglycaemic events (severe or blood-glucose-confirmed with symptoms, occurring between 00:01 and 05:59 h) and the rate of severe hypoglycaemic events during the maintenance period. Overall symptomatic, nocturnal symptomatic and severe hypoglycaemic events were also assessed during the total treatment period (up to 88 weeks) as secondary endpoints. Other secondary endpoints included change from baseline to end of treatment in HbA_1c level and FPG level, basal insulin dose at the end of treatment, pre-breakfast SMBG level and body weight. The composite endpoints HbA_1c <53 mmol/mol (7.0%) with no overall symptomatic hypoglycaemia and HbA_1c <53 mmol/mol (7.0%) with no nocturnal symptomatic hypoglycaemia were assessed during the maintenance period. The number of adverse events between the two treatment arms was also assessed during the trial period. An independent external event adjudication committee validated the following selected adverse events in a blinded manner: fatal events and severe hypoglycaemia.