Outcome measures
hypglycaemia, hypoglycaemia
ADVERSE EVENTS, ASYMPTOMATIC HYPOGLYCAEMIA, HYPOGLYCAEMIA
The primary endpoint was the change in HbA1c from baseline to 12 months. Secondary outcomes included change in body weight, BMI and TDD from baseline to Visit 3. The change in HbA1c was also analysed in the subgroups of patients with a baseline HbA1c ≥ 6.5% and <6.5% (48 mmol/mol). Percentage of patients experiencing at least one episode of documented (SMBG < 3.9 mmol/L) or symptomatic hypoglycaemia was assessed, and the hypoglycaemia data for the month before BV and the last 3 months of the 12‐month follow‐up were compared. Severe hypglycaemia requiring external assistance and occurrence of clinically meaningful adverse events were also recorded. Proportion of patients reaching different prespecified glycaemic targets (HbA1c < 7% and <6.5% [53 and 48 mmol/mol]) at Visit 3 were evaluated.