Abstract
INTRODUCTION: The aim of this study was to evaluate the glycemic control and safety of insulin degludec/insulin aspart (IDegAsp) co-formulation in Japanese patients with type 2 diabetes (T2D) in a real-world clinical setting, including elderly patients (aged > 75 years). METHODS: Patients (≥ 18 years) diagnosed with T2D, previously treated with insulin were included from the Japanese Medical Data Vision database. Baseline data were taken at the index date, defined as the first IDegAsp prescription claim. Change in glycated hemoglobin (HbA(1c)) at 12 months was estimated using a mixed model repeated measures analysis. The proportion of patients achieving target HbA(1c) < 8.0% without experiencing hypoglycemia (identified by International Classification of Disease codes) was calculated at 12 months (365 ± 90 days) after baseline. RESULTS: Overall, 10,798 patients were included, 3940 were aged > 75 years, and 913 had baseline HbA(1c) values available. Switching to IDegAsp was associated with significantly improved HbA(1c) values at 12 months (- 1.23% [- 1.43, - 1.02](95%CI), p < 0.001) versus baseline. Moreover, relative to baseline, a significantly greater proportion of patients achieved HbA(1c) < 8.0% without hypoglycemia at 12 months, relative rate (RR) 1.30 [1.15, 1.45](95%CI), p < 0.001. Results were similar for patients aged ≤ 75 years and aged > 75 years; 66% and 64% of patients, respectively, achieved HbA(1c) < 8.0% without hypoglycemia at 12 months. CONCLUSION: Switching from insulin to IDegAsp co-formulation was associated with significantly improved glycemic control and a reduction in hypoglycemia rate during 12 months of follow-up in Japanese patients with T2D, including those aged > 75 years.