EXPERT OPINION ON PHARMACOTHERAPY
Odawara, Masato Tokyo Medical University
Hirose, Takahisa Toho University
Koshida, Ryusuke Sanofi K.K.
Senda, Masayuki Sanofi K.K.
Tanaka, Yasushi St. Marianna University School of Medicine
Terauchi, Yasuo Yokohama City University
Background: With limited real-world insulin glargine 300 unit/mL (Gla-300) data available, we assessed the effectiveness and safety of Gla-300 in the Japanese type 2 diabetes mellitus (T2DM) population.
Research design and methods: X-STAR was a prospective, observational, 12-month post-marketing study of Gla-300 from 2015 to 2018. T2DM patients received Gla-300 as the first insulin (insulin-naïve) or after treatment with another type of insulin (insulin-experienced).
Results: We identified 1,227 insulin-naïve and 3,394 insulin-experienced patients. Insulin-naïve group increased the Gla-300 starting dose by 2.80 U/day during 12 months (7.49 to 10.29 U/day). Mean HbA1c reduced by 1.99% (9.82 to 7.83%), and 28.4% showed HbA1c < 7.0%. Insulin-experienced group had a baseline insulin dose of 14.86 U/day, which increased by 0.73 U/day. Mean HbA1c reduced by 0.18% (7.99 to 7.81%), and 24.6% showed HbA1c < 7.0%. Adverse drug reactions occurred in 3.42% (insulin-naïve) and 4.45% (insulin-experienced); symptomatic hypoglycemia (2.93% and 3.86%, respectively) was the most common in both groups.
Conclusions: Gla-300, in clinical practice, provides an effective and safe therapy as HbA1c was reduced/maintained in insulin-naïve/experienced Japanese T2DM patients without new safety signal. This study provides insights into the current Japanese clinical practices where insulin use is delayed and conservative despite relatively low HbA1c achievement.
Expert Opinion on Pharmacotherapy
Informa|Taylor & Francis
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