Efficacy and safety of ipragliflozin as add-on therapy to insulin in Japanese patients with type 2 diabetes mellitus (IOLITE): a multi-centre, randomized, placebo-controlled, double-blind study.
Efficacy and safety of ipragliflozin as add-on therapy to insulin in Japanese patients with type 2 diabetes mellitus (IOLITE): a multi-centre, randomized, placebo-controlled, double-blind study.
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DOI：
10.1111/dom.12745
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发表时间：
2016-12
期刊：
影响因子：
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通讯作者：
Asahina S
中科院分区：
文献类型：
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作者：
Ishihara H;Yamaguchi S;Nakao I;Okitsu A;Asahina S
在日本2型糖尿病患者胰岛素治疗早期检查添加伊格列净的疗效和安全性。接受胰岛素（餐时胰岛素成分<每日总剂量的30%）联合/不联合二肽基肽酶-4（DPP-4）抑制剂治疗的患者随机接受安慰剂（n = 87）或伊格列净（n = 175）治疗16周。主要终点是糖化血红蛋白（HbA 1c）较基线的变化。次要终点包括空腹血糖（FPG）和代谢激素的变化。还检查了安全性终点。HbA 1c的变化分别为0.27%和-0.79%安慰剂组和伊格列净组分别为2.9和-8.7 mmol/mol（基准线：8.62% vs 8.67% [70.8 vs 71.2 mmol/mol]），相当于校正后的平均差异为−1.07%（95%置信区间-1.24，-0.91）或-11.7 mmol/mol（-13.5，-9.9），p <0.001。伊格列净降低FPG和血清C肽水平和体重（所有p < .001），并增加血清脂联素水平（p = .022）。对于HbA 1c的变化，使用/不使用DPP-4抑制剂×治疗组存在统计学显著性相互作用（p = .042）。低血糖是>5%患者报告的唯一治疗相关不良事件（14.9% vs 29.1%）。与尿路感染（安慰剂组1.1% vs伊格列净组2.3%）或生殖器感染（分别为0.0%和4.0%）一致的事件发生在<5%的患者中。在胰岛素治疗患者中，伊格列净耐受性良好且有效，尤其是与DPP-4抑制剂联合使用时。
To examine the efficacy and safety of add‐on ipragliflozin in Japanese patients with type 2 diabetes in the early stage of insulin therapy. Patients treated with insulin (bolus component <30% of total daily dose) with/without a dipeptidyl peptidase‐4 (DPP‐4) inhibitor were randomized to receive placebo (n = 87) or ipragliflozin (n = 175) for 16 weeks. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline. Secondary endpoints included changes in fasting plasma glucose (FPG) and metabolic hormones. Safety endpoints were also examined. The changes in HbA1c were 0.27% and −0.79% (2.9 and −8.7 mmol/mol) in the placebo and ipragliflozin groups, respectively (baseline: 8.62% vs 8.67% [70.8 vs 71.2 mmol/mol]), corresponding to an adjusted mean difference of −1.07% (95% confidence interval −1.24, −0.91) or −11.7 mmol/mol (−13.5, −9.9), p < .001. Ipragliflozin reduced FPG and serum C‐peptide levels and body weight (all p < .001), and increased serum adiponectin levels (p = .022). There was a statistically significant interaction for use/non‐use of a DPP‐4 inhibitor × treatment group for the change in HbA1c (p = .042). Hypoglycaemia was the only treatment‐related adverse event reported in >5% of patients (14.9% vs 29.1%). Events consistent with urinary tract infection (placebo 1.1% vs ipragliflozin 2.3%) or genital infection (0.0% and 4.0%, respectively) occurred in <5% of patients. Ipragliflozin was well tolerated and effective in insulin‐treated patients, especially when used with a DPP‐4 inhibitor.