Abstract
BackgroundAdd-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.MethodsAmong 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.ResultsAmong 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).ConclusionOur 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.
Highlights
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
4219 patients were included in the safety analysis set (Figure 1). This set is further divided into 2 sub-groups: 1) Insulin-naïve group: patients treated with Oral antidiabetic drug (OAD) (n = 3732), and 2) Insulin non-naïve group: patients treated with OADs + insulin other than
*Insulin-naïve group: patients having been treated with OADs (n = 3732). †Insulin non-naïve group: patients treated with OADs + insulin other than insulin glargine, and switching to OADs + insulin glargine (n = 487)
Summary
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. Hypoglycemia impacts morbidity, mortality and quality of life of these patients [4,7,8,9], and leads to higher medical expenditure [10] It can pose a hindrance in the management of T2DM and can be major barrier in initiating and intensifying insulin treatment. Earlier studies in Japan demonstrated that BOT with insulin glargine was effective, without causing serious hypoglycemia [19,20] Another way to prevent or limit the incidence of hypoglycemia is to understand the underlying contributing factors. Earlier studies demonstrated that factors like old age, long disease duration, poor renal function, peripheral neuropathy, low body mass index (BMI), ≥2glucose-lowering drugs, long duration of insulin treatment, etc. are significant independent predictors of hypoglycemia [3,21,22]
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