REDUCED HYPOGLYCEMIA AND COMPARABLE EFFICACY WITH INSULIN GLARGINE 300 U/ML VERSUS INSULIN GLARGINE 100 U/ML IN PATIENTS WITH TYPE 2 DIABETES ACHIEVING DIFFERENT LEVELS OF PREBREAKFAST SELF-MONITORED PLASMA GLUCOSE

Objective: To evaluate the efficacy and safety of insulin glargine 300 U/mL (Gla-300) and insulin glargine 100 U/mL (Gla-100) in patients with type 2 diabetes (T2D) who reached prebreakfast self-monitored plasma glucose (SMPG) levels < 100 and < 130 mg/dL. Methods: This was a post hoc analysis of insulin-naive (EDITION 3, NCT01676220) and experienced (EDITION 2, NCT01499095) patients with uncontrolled T2D, randomized to 6 months of Gla-300 versus Gla-100 treatment. Endpoints included glycated hemoglobin A1c change, hypoglycemia incidence, and event rates. Separate comparisons were done for patients achieving prebreakfast fasting glucose of < 100 versus >= 100 mg/dL and < 130 versus >= 130 mg/dL. Results: Efficacy did not differ significantly between treatments in either study. Overall, basal insulin doses were similar to 10% higher with Gla-300 versus Gla-100. EDITION 2: overall and documented (<= 70 mg/dL) hypoglycemia rates were significantly lower with Gla-300 versus Gla-100 in all SMPG groups except < 100 mg/dL; nocturnal hypoglycemia rates were significantly lower with Gla-300 in all SMPG groups. EDITION 3: overall hypoglycemia rates were significantly lower with Gla-300 in patients with SMPG >= 100 mg/dL and those with SMPG < 130 mg/dL; documented hypoglycemia rates were significantly lower in all SMPG groups except >= 130 mg/dL. Nocturnal and nocturnal documented hypoglycemia rates did not differ by treatment group. Hypoglycemia incidence did not differ by treatment in any SMPG group. Conclusion: In patients with T2D initiating basal insulin or previously treated for >= 6 months with basal insulin, Gla-300 provides similar efficacy to Gla-100 and reduces risk of hypoglycemia for many patients, despite a similar to 10% higher insulin dose.