Basalog® is similar to Lantus® in producing glycemic control in patients with type 1 diabetes mellitus on multiple daily insulin regimens

This study was performed to compare the insulin glargine produced by two different manufacturers. The study determines the efficacy and safety of a new insulin glargine (Basalog®) having the same amino-acid sequence as Lantus® in patients with type 1 diabetes mellitus on multiple daily insulin regimen. After a run-in period of 4 weeks on once-daily Lantus®, patients were randomized in 1:1 ratio to receive once-daily treatment with either Basalog® ( n = 107) or Lantus® ( n = 108) for 12 weeks in this open-label multicenter study. Patients were enrolled from 15 hospitals in India. Change in HbA1c was the primary efficacy parameter; FPG, 7-point glucose profile and PPG were the secondary efficacy parameters. Hypoglycemia and immunogenicity were the main safety parameters. This was a non-inferiority study where non-inferiority could be claimed if mean difference (including 95% CI) was less than or equal to 0.5% for the primary efficacy parameter HbA1c. There was no statistically significant difference between the groups with respect to change in HbA1c ( p = 0.69), FPG ( p = 0.25) or PPG ( p = 0.68). The change in HbA1c from baseline to end-point was 7.86 ± 1.11 to 7.80 ± 1.24% in Basalog® treated patients and 7.76 ± 1.17 to 7.58 ± 1.27% in Lantus® treated patients. Proportion of patients achieving HbA1c