Apidra(insulin glulisine [rDNA origin] injection)

Apidra (insulin glulisine [rDNA origin] injection) is a rapid-acting human insulin analog approved on February 24, 2009, to improve glycemic control in adults and children with diabetes mellitus. It is available in 3 mL SoloStar® prefilled pens (100 units/mL), 10 mL vials, and 3 mL cartridge systems for use in OptiClik®.

In efficacy studies, Apidra demonstrated a HbA1c change from baseline of -0.1%. The HbA1c treatment difference between Apidra and Insulin Lispro was 0.0. Body weight change from baseline was observed at 0.6 kg and 0.3 kg in different studies. For device evaluation, correct response rates for differentiated pens ranged from 96% to 98%, while for undifferentiated pens, rates were 79% to 80%. In isolation, Apidra SoloStar showed correct responses of 96% to 100% in differentiated arms and 75% to 77% in undifferentiated arms.

Safety data indicated a hypoglycemic seizure rate of 6.1% for Apidra compared to 4.7% for Lispro. Severe symptomatic hypoglycemia events per month per patient for Type 1 Diabetes Adults were 0.02 for Apidra and 0.02 for Insulin Lispro, and 0.09 for Type 1 Diabetes Pediatrics with Apidra. For Type 2 Diabetes Adults, severe symptomatic hypoglycemia events were 0.00 for both Apidra and Regular Human Insulin.