ADA 2013：达格列净（Dapagliflozin ）单药治疗未曾用药的T2DM安全有效

    2013年第73届美国糖尿病协会科学年会(ADA2013)于6月21日~25日在美国芝加哥隆重举办。在ADA2013年会上，北京大学第一医院纪立农教授有5篇中国研究入选壁报讨论(2篇 General Poster Sessions)和会议摘要(3篇 Published  Only)。其中一篇壁报为“单纯饮食或运动控制不佳的亚洲2型糖尿病患者使用达格列净单药治疗”，提示达格列净单药治疗未曾用药的亚洲2型糖尿病患者安全、有效，并且可以轻度降低体重。
　　达格列净(DAPA)是一种选择性钠葡萄糖转运蛋白(SGLT2)抑制剂，在不同种族中的研究显示它可以作为单药或与其他药物联用降低血糖。
　　我们进行了一项为期24周的双盲研究(NCT01095653)，旨在评估对于单纯饮食或运动控制不佳的亚洲2型糖尿病患者(HbA1c  7.0-10.5%)使用达格列净单药治疗的疗效。患者被随机分入对照组(PBO; N=132)和达格列净组(5 mg或者 10 mg; N=128 或n= 133  )。
　　组间的基线资料具有可比性，大多数(89%)为汉族，平均糖尿病病程为0.2年。24周之后，和安慰剂组相比，达格列净5 mg或者10  mg剂量依赖性的降低糖化血红蛋白(主要终点)，空腹血糖、餐后血糖、体重、HbA1c < 7%的患者比例(次级终点)也有类似的趋势。组间不良反应的发生率相似。极少有严重的不良反应或导致停药的不良反应。低血糖少见(安慰剂组为1.5%，达格列净5mg组为0.8%  ，达格列净10mg组为0.8%)，没有患者因低血糖而停药。生殖器感染在达格列净组更为常见，三组的发生率分别为0.8%、3.1%  和4.5%。三组尿路感染的发生率分别为3.0%、 3.9%和5.3%。没有发生肾功能衰竭、肾盂肾炎或死亡。
　　总之，达格列净单药治疗未曾用药的亚洲2型糖尿病患者安全、有效，并且可以轻度降低体重。

【研究摘要】

Dapagliflozin as Monotherapy in Drug-Naïve Asian Patients with T2DM  Inadequately Controlled on Diet and Exercise
Linong Ji MD Peking University

Dapagliflozin (DAPA) a selective SGLT2 inhibitor improves glycemic control in  diverse patient populations as monotherapy or in combination with other  glucose-lowering drugs. We assess DAPA as monotherapy in drug-naïve Asian  patients inadequately controlled on diet and exercise (HbA1c 7.0-10.5%) in a  24-week double-blind study (NCT01095653) that randomized patients to placebo  (PBO; N=132) or DAPA (5 or 10 mg; N=128 and 133 respectively) groups. Baseline  characteristics were balanced across groups. Most patients (89%) were Chinese.  Median duration of T2DM was 0.2 years. At week 24 (LOCF) DAPA 5 and 10 mg  provided dose-dependent statistically significant reductions in HbA1c vs PBO  (primary endpoint) and in FPG PPG body weight and proportion of patients with  HbA1c <7% (secondary endpoints) (Table). Adverse events (AEs) were balanced  across groups. Few patients had serious AEs or AEs leading to discontinuation.  Hypoglycemia was uncommon (1.5 0.8 and 0.8% in the PBO DAPA 5 mg and 10 mg  groups respectively); none led to discontinuation. Genital infections were more  common with DAPA; 0.8 3.1 and 4.5% of PBO DAPA 5 mg or 10 mg patients  respectively. UTIs occurred in 3.0 3.9 and 5.3% of patients respectively. No AEs  of renal failure or pyelonephritis and no deaths occurred. In summary DAPA as  monotherapy in drug-naïve Asian patients was well-tolerated significantly  improving glycemic control with the additional benefit of modest weight  loss.