11. Efficacy and safety for insulin glargine biosimilar in patients with type 1 diabetes mellitus undergoing intensive insulin treatment

Abstract:

Comparability in efficacy and similarity in safety between Insulin Glargine Biosimilar (herein-after referred to as FFP∼112) and Lantus® were investigated in Japanese patients with type 1 diabetes mellitus on intensive insulin therapy. A total of 260 subjects was administered the investigational drug (131 treated with FFP- 112 and 129 treated with Lantus®). Hemoglobin Ale (HbAlc) change from baseline to week 24 (mean ± standard deviation) as the primary endpoint was -0.01 ±0.54% in FFP-112 and -0.05 ±0.62% in Lantus®. The estimated difference in adjusted mean (95% confidence interval) for FFP-112 compared with Lantus® was 0.03% (-0.10 to 0.17). This result met the prespecified criteria for equivalence (-0.45 to 0.45), demonstrating that FFP-112 is equivalent to Lantus®. Secondary endpoints of efficacy were the changes in HbAlc, fasting blood glucose before breakfast, 7-point self-monitored blood glucose and basal-bolus insulin regimen. Secondary endpoints of safety included adverse events, adverse drug reactions, hypoglycemia, incidence of anti-insulin glargine and anti-insulin antibodies, and other test parameters. These analyses showed that each of secondary endpoints was not largely different clinically between FFP-112 and Lantus® throughout the study period, indicating similarities between the two products. The results above demonstrate that FFP-112 is comparable to Lantus® in efficacy, showing that FFP-112 can provide comparable glyceamic control at doses similar to Lantus® doses. Thus, as with Lantus®, FFP-112 is expected to provide long-term stable glyceamic control when administered in combination with bolus insulin. It is also shown that FFP-112 and Lantus® have a similar safety profile. It is thus concluded that FFP-112 is a useful treatment for patients with diabetes mellitus for whom insulin therapy is indicated