A Clinical Trial to Maintain Glycemic Control in Youth with Type 2 Diabetes
A Clinical Trial to Maintain Glycemic Control in Youth with Type 2 Diabetes
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DOI：
10.1056/nejmoa1109333
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发表时间：
2012-06-14
影响因子：
158.5
通讯作者：
Kaufman, Francine
中科院分区：
文献类型：
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作者：
Zeitler, Phil;Hirst, Kathryn;Kaufman, Francine
尽管青年2型糖尿病的患病率越来越高，但指导治疗的数据很少。我们比较了三种治疗方案在儿童和青少年新发2型糖尿病患者中实现持久血糖控制的疗效。（剂量为1000 mg，每日两次），以达到糖化血红蛋白水平低于8%随机分配至二甲双胍单药治疗组或二甲双胍联合罗格列酮组（4毫克，每天两次）或生活方式干预计划，重点是通过饮食和活动行为减肥。主要结果是血糖控制的丧失，定义为糖化血红蛋白水平至少8%持续6个月或持续代谢失代偿需要胰岛素。在699名随机分配的参与者中（诊断为2型糖尿病的平均持续时间为7.8个月），319名（45.6%）在平均3.86年的随访中达到主要结果。二甲双胍单药、二甲双胍加罗格列酮和二甲双胍加生活方式干预的失败率分别为51.7%（120/232例受试者）、38.6%（90/233例）和46.6%（109/234例）。二甲双胍加罗格列酮上级优于二甲双胍单药治疗（P = 0.006）;二甲双胍加生活方式干预居中，但与二甲双胍单药治疗或二甲双胍加罗格列酮治疗无显著差异。根据性别和种族或种族组的预先规定的分析显示持续有效性的差异，二甲双胍单药在非西班牙裔黑人受试者中效果最差，二甲双胍加罗格列酮在女孩中最有效。19.2%的参与者报告了严重的不良事件。结论二甲双胍单药治疗与大约一半的2型糖尿病儿童和青少年的持久血糖控制相关。添加罗格列酮，但不是强化的生活方式干预，上级二甲双胍单药。（由国家糖尿病、消化和肾脏疾病研究所和其他机构资助;今日ClinicalTrials.gov编号，NCT 00081328。
BACKGROUNDDespite the increasing prevalence of type 2 diabetes in youth, there are few data to guide treatment. We compared the efficacy of three treatment regimens to achieve durable glycemic control in children and adolescents with recent-onset type 2 diabetes.METHODSEligible patients 10 to 17 years of age were treated with metformin (at a dose of 1000 mg twice daily) to attain a glycated hemoglobin level of less than 8% and were randomly assigned to continued treatment with metformin alone or to metformin combined with rosiglitazone (4 mg twice a day) or a lifestyle-intervention program focusing on weight loss through eating and activity behaviors. The primary outcome was loss of glycemic control, defined as a glycated hemoglobin level of at least 8% for 6 months or sustained metabolic decompensation requiring insulin.RESULTSOf the 699 randomly assigned participants (mean duration of diagnosed type 2 diabetes, 7.8 months), 319 (45.6%) reached the primary outcome over an average follow-up of 3.86 years. Rates of failure were 51.7% (120 of 232 participants), 38.6% (90 of 233), and 46.6% (109 of 234) for metformin alone, metformin plus rosiglitazone, and metformin plus lifestyle intervention, respectively. Metformin plus rosiglitazone was superior to metformin alone (P = 0.006); metformin plus lifestyle intervention was intermediate but not significantly different from metformin alone or metformin plus rosiglitazone. Prespecified analyses according to sex and race or ethnic group showed differences in sustained effectiveness, with metformin alone least effective in non-Hispanic black participants and metformin plus rosiglitazone most effective in girls. Serious adverse events were reported in 19.2% of participants.CONCLUSIONSMonotherapy with metformin was associated with durable glycemic control in approximately half of children and adolescents with type 2 diabetes. The addition of rosiglitazone, but not an intensive lifestyle intervention, was superior to metformin alone. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; TODAY ClinicalTrials.gov number, NCT00081328.)