Incidence and predictors of hypoglycemia in Japanese patients with type 2 diabetes treated by insulin glargine and oral antidiabetic drugs in real-life: ALOHA post-marketing surveillance study sub-analysis

Diabetology & Metabolic Syndrome

Yusuke Naito¹  Takashi Kadowaki²  Masato Odawara³ 

[1] Sanofi K.K, 3-20-2 Nishi-Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan;Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan;Department of Diabetology, Metabolism, and Endocrinology, Tokyo Medical University, 6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo 160-0023, Japan

关键词: Relative risk;    Type 2 diabetes;    Oral antidiabetic drugs;    Insulin-naïve;    Insulin glargine;    Hypoglycemia;   

Others  :  805331
DOI  :  10.1186/1758-5996-6-20

 received in 2013-09-10, accepted in 2014-02-08,  发布年份 2014

【 摘 要 】

Background

Add-on Lantus® to Oral Hypoglycemic Agents (ALOHA), an observational, non-interventional, 24-week post-marketing surveillance study in Japanese patients with type 2 diabetes (T2DM) having uncontrolled glycemic control, demonstrated that basal supported oral therapy (BOT) with insulin glargine was an effective and safe treatment in real-life clinical practice. We performed subgroup analysis to identify incidence and predictors associated with risk of hypoglycemia.

Methods

Among 4219 patients with T2DM, 3732 patients were insulin-naïve and 487 patients were insulin non-naïve who switched from other insulin to insulin glargine. All hypoglycemic episodes were counted by physicians’ documentation based on patients’ reports. Relationships between baseline patient characteristics and glargine-related hypoglycemic episodes were examined by univariate and multivariate analysis.

Results

Among 4219 patients, 44 (1.0%) patients experienced hypoglycemic episodes (41 insulin-naïve patients; 3 insulin non-naïve patients), with a rate of incidence 0.035 episodes/patient-years. Majority of patients with hypoglycemia (37 of 44) had just one hypoglycemic episode during study period. Among insulin-naïve patients, incidence of hypoglycemia differed significantly depending on age, diabetic complications, estimated glomerular filtration rate (eGFR), and postprandial plasma glucose (P <0.05). In a multivariate adjusted model, poor renal function (eGFR <60 mL/min/1.73 m²) was a statistically significant risk factor (P < 0.05).

Conclusion

Our results suggest that BOT using insulin glargine is an option of insulin therapy with 1% risk of hypoglycemia in patients with T2DM with inadequate glycemic control. Patients with low renal function might need a careful follow-up.

【 授权许可】

   
2014 Odawara et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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