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Dapagliflozin as Monotherapy in Drug-Naive Asian Patients With Type 2 Diabetes Mellitus: A Randomized, Blinded, Prospective Phase III Study
Ji, Linong1; Ma, Jianhua2; Li, Hongmei3; Mansfield, Traci A.4; T&prime1; joen, Caroline L.5; Iqbal, Nayyar4; Ptaszynska, Agata4; List, James F.4
关键词Asian Dapagliflozin Glycemic Control Monotherapy Sglt2 Type 2 Diabetes Mellitus
刊名CLINICAL THERAPEUTICS
2014
DOI10.1016/j.clinthera.2013.11.002
36期:1页:84-100
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Pharmacology & Pharmacy
研究领域[WOS]Pharmacology & Pharmacy
关键词[WOS]INADEQUATE GLYCEMIC CONTROL ; PLACEBO-CONTROLLED TRIAL ; BODY-MASS INDEX ; SGLT2 INHIBITOR ; CUTOFF POINTS ; METFORMIN ; RISK ; EFFICACY ; PHARMACOKINETICS ; CANAGLIFLOZIN
英文摘要

Objective: Dapagliflozin is a highly selective, orally active inhibitor of renal sodium-glucose cotransporter 2 that reduces hyperglycemia by increasing urinary glucose excretion. The goal of this study was to evaluate dapagliflozin as monotherapy in drug-naive Asian patients with type 2 diabetes whose disease was inadequately controlled with diet and exercise.

Methods: In this Phase III, multicenter, parallel-group, double-blind study, drug-naive patients with glycosylated hemoglobin (HbA(1c)) levels >= 7.0% to <= 10.5% (>= 53-<= 91 mmol/mol) were randomized (by using an interactive voice response system) to receive placebo (n = 132), dapagliflozin 5 mg (n = 128), or dapagliflozin 10 mg (n = 133). The primary end point was mean change from baseline in HbA(1c), level at week 24 (last-observation-carried-forward). Secondary end points included changes in fasting plasma glucose, 2-hour postprandial glucose, body weight, and other glycemic parameters.

Results: Baseline characteristics were balanced across groups. Most patients (89%) were Chinese, median disease duration was 0.2 year, and mean HbA(1)c level was 8.26%. Most patients (87%) completed the study. At week 24, mean reductions in HbA(1c) were -0.29% for placebo versus -1.04% and -1.11% for dapagliflozin 5 and 10 mg, respectively (P < 0.0001 for both doses). Changes in fasting plasma glucose were 2.5, -25.1, and -31.6 mg/dL (0.14, -1.39, and -1.75 mmol/L) for placebo, dapagliflozin 5 mg, and dapagliflozin 10 mg. Changes in 2-hour postprandial glucose were 1.1, -46.8, and -54.9 mg/dL (0.06, -2.60, and -3.05 mmol/L). Reductions in body weight were -0.27, -1.64, and -2.25 kg. Proportions of patients achieving HbA(1c) levels <7.0% (53 mmol/mol) were 21.3%, 42.6%, and 49.8%. Adverse events (AEs) occurred in 63.6%, 61.7%, and 60.9% of patients, and serious AEs occurred in 1.5%, 3.9%, and 3.0% of patients. No deaths occurred. Hypoglycemia was uncommon (1.5%, 0.8%, and 0.8%); no hypoglycemic event led to discontinuation. Genital infections occurred in 0.8%, 3.1%, and 4.5% of patients and urinary tract infections in 3.0%, 3.9%, and 5.3% of patients. No AEs of renal infection or pyelonephritis were reported. No changes in renal function or AEs of renal failure occurred.

Conclusions: Compared with placebo, dapagliflozin 5 and 10 mg demonstrated clinically and statistically significant improvements in HbA(1c) levels after 24 weeks of treatment. Dose-dependent, statistically significant reductions in fasting plasma glucose, postprandial glucose, and weight were also observed for both doses compared with placebo. AEs and serious AEs were balanced across groups, with low rates of hypoglycemia and no increase in renal events. Genital infections and urinary tract infections were more common with dapagliflozin. Dapagliflozin as monotherapy in these drug-naive Asian patients was well tolerated, significantly improving glycemic control with the additional benefit of weight loss. (C) 2014 The Authors. Published by Elsevier, Inc. All rights reserved.

语种英语
WOS记录号WOS:000330254100010
资助机构Bristol-Myers Squibb ; AstraZeneca
引用统计
被引频次:54[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/52493
专题北京大学第二临床医学院
作者单位1.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China
2.Nanjing Med Univ, Nanjing Hosp 1, Jiansu, Peoples R China
3.Bristol Myers Squibb, Clin Res, China R&D, Shanghai, Peoples R China
4.Bristol Myers Squibb, Global Clin Res, Princeton, NJ 08540 USA
5.Bristol Myers Squibb, Global Biometr Sci, Braine L Alleud, Belgium
推荐引用方式
GB/T 7714
Ji, Linong,Ma, Jianhua,Li, Hongmei,et al. Dapagliflozin as Monotherapy in Drug-Naive Asian Patients With Type 2 Diabetes Mellitus: A Randomized, Blinded, Prospective Phase III Study[J]. CLINICAL THERAPEUTICS,2014,36(1):84-100.
APA Ji, Linong.,Ma, Jianhua.,Li, Hongmei.,Mansfield, Traci A..,T&prime.,...&List, James F..(2014).Dapagliflozin as Monotherapy in Drug-Naive Asian Patients With Type 2 Diabetes Mellitus: A Randomized, Blinded, Prospective Phase III Study.CLINICAL THERAPEUTICS,36(1),84-100.
MLA Ji, Linong,et al."Dapagliflozin as Monotherapy in Drug-Naive Asian Patients With Type 2 Diabetes Mellitus: A Randomized, Blinded, Prospective Phase III Study".CLINICAL THERAPEUTICS 36.1(2014):84-100.
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