Run-in period
Nordisk A/S
During the run-in period (3–49 days), participants received once-daily glargine U100 with or without any usual metformin to determine the individual basal glargine U100 dose titrated to a fasting self-measured PG target of 4.4–7.2 mmol/l. Randomisation was performed during the run-in period when the mean of 3 consecutive days’ fasting self-measured PG was within 4.4–7.2 mmol/l with stable glargine U100 dose. Each participant was assigned a randomisation number in ascending order at the clinical site, which encoded the participant’s assignment to one of two treatment sequences via a randomisation list prepared by the sponsor (Novo Nordisk A/S).