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

Abstract:

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 <7% was also comparable (40.48% in Basalog® vs 38.30% in Lantus®). The nature and frequency of adverse events, percentage of patients positive for anti-insulin glargine antibodies were similar in both groups. Forty-three (40.19%) subjects on Basalog® experienced at least one hypoglycaemic event, while 45 (41.67%) subjects on Lantus® experienced the same. Basalog® was found to have similar efficacy and safety as Lantus® in treatment of patients with type 1 diabetes mellitus.

Source(s) of Support: This study was sponsored and funded by Biocon Limited, Bangalore, India.