[ Ⅲ ].

To compare the efficacy and safety of Changsulin with Lantus in treating patients with type 2 diabetes mellitus (T2DM). This was a phase Ⅲ, multicenter, randomized, open-label, parallel-group, active-controlled clinical trial. A total of 578 participants with T2DM inadequately controlled on oral hypoglycemic agents were randomized 3∶1 to Changsulin or Lantus treatment for 24 weeks. The efficacy measures included changes in glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), 2h postprandial plasma glucose (2hPG), 8-point self-monitoring of blood glucose (SMBG) profiles from baseline, and proportions of subjects achieving targets of HbA1c and FPG. The safety outcomes included rates of hypoglycemia, adverse events (AEs) and anti-insulin glargine antibody. After 24 weeks of treatment, mean HbAlc decreased 1.16% and 1.25%, FPG decreased 3.05 mmol/L and 2.90 mmol/L, 2hPG decreased 2.49 mmol/L and 2.38 mmol/L in Changsulin and in Lantus, respectively. No significant differences could be viewed in above parameters between the two groups (all 0.05). There were also no significant differences between Changsulin and Lantus in 8-point SMBG profiles from baseline and proportions of subjects achieving the targets of HbA1c and FPG (all 0.05). The rates of total hypoglycemia (38.00% and 39.01% for Changsulin and Lantus, respectively) and nocturnal hypoglycemia (17.25% and 16.31% for Changsulin and Lantus, respectively) were similar between the two groups (all 0.05). Most of the hypoglycemia events were asymptomatic, and no severe hypoglycemia were found in both groups. No differences were observed in rates of AEs (61.77% vs.52.48%) and anti-insulin glargine antibody (after 24 weeks of treatment, 6.91% vs.3.65%) between the two groups (all 0.05). Changsulin shows similar efficacy and safety profiles compared with Lantus and Changsulin treatment was well tolerated in patients with T2DM.