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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

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