Aim: To compare the efficacy and safety of initiating Glargine U100 + Glulisine to Premixed insulin in insulin naïve Asian Indian type 2 diabetes (T2D) patients.
Method: We randomized 101 patients into Glargine U100 + Glulisine (Group 1) and 99 in premixed insulin (Group 2) from 7 different hospitals in Southern India and followed for 24 weeks. Randomized patients were insulin naïve T2D patients on oral antidiabetic drugs.
Results: In both the groups > 80% of patients needed an additional dose of insulin (Glulisine in Group 1 and premixed in group 2). There was a significant reduction in all glycemic levels in both groups (p < 0.05), except for a non-significant reduction in HbA1c in group 2 (Figure 1). The dose at the end of the study was 92 units in Group 1 and 50 units in group 2. There was no clinically significant change in body mass index in both groups. The number of episodes of hypoglycemia was significantly more in premixed insulin BD group compared to Glargine U100 + Glulisine BD group (χ2 - 6.1, p = 0.01).
Conclusion: Marginally better (non-significant) reduction in HbA1c was noted with Glargine U100 + Glulisine compared to premixed insulin. However, the dose required was higher in group 1 than group 2. The overall episodes of symptomatic hypoglycemia were significantly less in Glargine U100 + Glulisine when compared with the premixed insulin. There was no clinically significant change in body weight in both groups.
A. Raghavan: None. A. Nanditha: None. K. Satheesh: None. C. Snehalatha: None. A. Catherin Seeli: None. M. Simon: None. P. Susairaj: None. A. Ramachandran: None.
Sanofi India Limited