Solostar

Eligible participants were randomized in a 2:1 ratio to insulin degludec (IDeg, 100 U/mL, 3 mL FlexTouch^®; Novo Nordisk, Bagsværd, Denmark) or insulin glargine (IGlar, Lantus^®, 100 U/mL, 3 mL SoloSTAR^®; Sanofi-Aventis, Paris, France) once daily for 26 weeks. Randomization was performed using an interactive voice/web response system at each dispensing visit. Randomization was stratified according to region: China/non-China. The trial was open label, but treatment group assignment was blinded for internal titration surveillance committee members, internal safety committee members, external members of the cardiovascular event adjudication committee, and everyone involved in defining analysis sets and performing data review until the database was locked.

Participants were randomized (1 : 1) to receive once-daily injections of either Gla-300, using a modified TactiPen® injector (Sanofi, Paris, France), or Gla-100 (Lantus®; Sanofi), using a SoloSTAR® pen injector (Sanofi). Randomization was performed using a centralized interactive voice or internet response system and was stratified by HbA1c at the screening visit [<8.0 or ≥8.0 % (<64 or ≥64 mmol/mol)] and geographical region (non-Japan/Japan). Because of differences in the injection devices, this was an open-label study.