Rationale and design of the glycemia reduction approaches in diabetes: a comparative effectiveness study (GRADE).
Rationale and design of the glycemia reduction approaches in diabetes: a comparative effectiveness study (GRADE).
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DOI：
10.2337/dc13-0356
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发表时间：
2013-08
期刊：
影响因子：
16.2
通讯作者：
GRADE Study Research Group
中科院分区：
文献类型：
--
作者：
Nathan DM;Buse JB;Kahn SE;Krause-Steinrauf H;Larkin ME;Staten M;Wexler D;Lachin JM;GRADE Study Research Group
2型糖尿病（T2 DM）的流行有可能成为本世纪的主要公共卫生问题。然而，尚未对治疗T2 DM的药物的长期效果进行全面比较。GRADE是一项实用的、非盲临床试验，旨在比较常用的糖尿病药物与二甲双胍联合使用时的降糖效果和以患者为中心的结局。GRADE的设计得到了国家糖尿病、消化和肾脏疾病研究所（NIDDK）U34规划拨款的支持。该共识协议得到了NIDDK和GRADE研究小组的批准。5，000名二甲双胍治疗受试者的合格标准包括糖尿病病程<5年，诊断时年龄≥30岁，基线血红蛋白A1 c（A1 C）为6.8-8.5%（51-69 mmol/mol）。代表4类药物（磺酰脲类、二肽基肽酶4抑制剂、胰高血糖素样肽1受体激动剂和胰岛素）将被随机分配并添加至二甲双胍（最小-最大1，000 - 2，000 mg/天）。主要代谢结局是至原发性衰竭的时间，定义为A1 C ≥7%（53 mmol/mol），随后证实，预期平均观察期为4.8年（范围4-7年）。其他长期代谢结果包括在确认A1 C>7.5%（58 mmol/mol）后需要添加基础胰岛素，最终需要实施强化基础/餐时胰岛素方案。还将比较这四种药物的微血管并发症、心血管疾病风险因素、不良反应、耐受性、生活质量和成本效益。GRADE将比较主要降糖药物的长期有效性，并为临床医生提供最适合治疗T2 DM的药物的指导。GRADE于2013年在美国的37个中心开始招募。
The epidemic of type 2 diabetes (T2DM) threatens to become the major public health problem of this century. However, a comprehensive comparison of the long-term effects of medications to treat T2DM has not been conducted. GRADE, a pragmatic, unmasked clinical trial, aims to compare commonly used diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and patient-centered outcomes. GRADE was designed with support from a U34 planning grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The consensus protocol was approved by NIDDK and the GRADE Research Group. Eligibility criteria for the 5,000 metformin-treated subjects include <5 years' diabetes duration, ≥30 years of age at time of diagnosis, and baseline hemoglobin A1c (A1C) of 6.8–8.5% (51–69 mmol/mol). Medications representing four classes (sulfonylureas, dipeptidyl peptidase 4 inhibitors, glucagon-like peptide 1 receptor agonists, and insulin) will be randomly assigned and added to metformin (minimum–maximum 1,000–2,000 mg/day). The primary metabolic outcome is the time to primary failure defined as an A1C ≥7% (53 mmol/mol), subsequently confirmed, over an anticipated mean observation period of 4.8 years (range 4–7 years). Other long-term metabolic outcomes include the need for the addition of basal insulin after a confirmed A1C >7.5% (58 mmol/mol) and, ultimately, the need to implement an intensive basal/bolus insulin regimen. The four drugs will also be compared with respect to selected microvascular complications, cardiovascular disease risk factors, adverse effects, tolerability, quality of life, and cost-effectiveness. GRADE will compare the long-term effectiveness of major glycemia-lowering medications and provide guidance to clinicians about the most appropriate medications to treat T2DM. GRADE begins recruitment at 37 centers in the U.S. in 2013.
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影响因子：
158.5
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