Efficacy and safety of the addition of sitagliptin to treatment of youth with type 2 diabetes and inadequate glycemic control on metformin without or with insulin

磷酸西他列汀 医学 二甲双胍 血糖性 磷酸西他列汀 安慰剂 2型糖尿病 内科学 胰岛素 不利影响 临床终点 超重 二肽基肽酶-4抑制剂 内分泌学 糖尿病 随机对照试验 肥胖 替代医学 病理
作者
Muhammad Yazid Jalaludin,Asma Deeb,Philip Zeitler,Raymundo Garcia,Ron S. Newfield,Ю. Г. Самойлова,Carmen A. Rosario,Naim Shehadeh,Chandan Saha,Yilong Zhang,Martina Zilli,Lynn W. Scherer,Raymond L. H. Lam,Gregory T. Golm,Samuel S. Engel,Keith D. Kaufman,R. Ravi Shankar
出处
期刊:Pediatric Diabetes [Wiley]
卷期号:23 (2): 183-193 被引量:23
标识
DOI:10.1111/pedi.13282
摘要

To assess the efficacy and safety of sitagliptin in youth with type 2 diabetes (T2D) inadequately controlled with metformin ± insulin.Data were pooled from two 54-week, double-blind, randomized, placebo-controlled studies of sitagliptin 100 mg daily or placebo added onto treatment of 10- to 17-year-old youth with T2D and inadequate glycemic control on metformin ± insulin. Participants (N = 220 randomized and treated) had HbA1c 6.5%-10% (7.0%-10% if on insulin), were overweight/obese at screening or diagnosis and negative for pancreatic autoantibodies. The primary endpoint was change from baseline in HbA1c at Week 20.Treatment groups were well balanced at baseline (mean HbA1c = 8.0%, BMI = 30.9 kg/m2 , age = 14.4 years [44.5% <15], 65.9% female). The dose of background metformin was >1500 mg/day for 71.8% of participants; 15.0% of participants were on insulin therapy. At Week 20, LS mean changes from baseline (95% CI) in HbA1c for sitagliptin/metformin and placebo/metformin were -0.58% (-0.94, -0.22) and -0.09% (-0.43, 0.26), respectively; difference = -0.49% (-0.90, -0.09), p = 0.018; at Week 54 the LS mean (95% CI) changes were 0.35% (-0.48, 1.19) and 0.73% (-0.08, 1.54), respectively. No meaningful differences between the adverse event profiles of the treatment groups emerged through Week 54.These results do not suggest that addition of sitagliptin to metformin provides durable improvement in glycemic control in youth with T2D. In this study, sitagliptin was generally well tolerated with a safety profile similar to that reported in adults. (ClinicalTrials.gov: NCT01472367, NCT01760447; EudraCT: 2011-002529-23/2014-003583-20, 2012-004035-23).

科研通智能强力驱动
Strongly Powered by AbleSci AI
科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
only发布了新的文献求助10
1秒前
赘婿应助xixi采纳,获得10
1秒前
1秒前
过时的冬易完成签到,获得积分10
1秒前
2秒前
李健应助winnie_ymq采纳,获得10
3秒前
5秒前
5秒前
李小聪发布了新的文献求助10
6秒前
稳重芷卉完成签到,获得积分10
6秒前
7秒前
8秒前
酷波er应助流奔儿采纳,获得10
8秒前
小二郎应助王思远采纳,获得10
8秒前
香蕉觅云应助arui采纳,获得10
9秒前
9秒前
10秒前
酷酷玉兰完成签到 ,获得积分10
10秒前
晗月完成签到,获得积分0
10秒前
w1kend发布了新的文献求助10
10秒前
领导范儿应助zhangxia采纳,获得10
11秒前
丘比特应助李小聪采纳,获得10
12秒前
shrry给shrry的求助进行了留言
12秒前
12秒前
王涛发布了新的文献求助10
12秒前
量子星尘发布了新的文献求助10
12秒前
14秒前
14秒前
星辰大海应助啦啦啦啦啦采纳,获得10
15秒前
bkagyin应助轻松的海燕采纳,获得10
15秒前
15秒前
无题发布了新的文献求助10
15秒前
wenjiahua发布了新的文献求助10
16秒前
16秒前
论文爱我发布了新的文献求助10
17秒前
17秒前
天天快乐应助坤坤探花采纳,获得10
18秒前
乐乐应助炙热的翠梅采纳,获得10
18秒前
19秒前
19秒前
高分求助中
(应助此贴封号)【重要!!请各用户(尤其是新用户)详细阅读】【科研通的精品贴汇总】 10000
Handbook of pharmaceutical excipients, Ninth edition 5000
Aerospace Standards Index - 2026 ASIN2026 3000
Signals, Systems, and Signal Processing 610
Discrete-Time Signals and Systems 610
Social Work and Social Welfare: An Invitation(7th Edition) 410
Medical Management of Pregnancy Complicated by Diabetes 400
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 纳米技术 有机化学 物理 生物化学 化学工程 计算机科学 复合材料 内科学 催化作用 光电子学 物理化学 电极 冶金 遗传学 细胞生物学
热门帖子
关注 科研通微信公众号,转发送积分 6056497
求助须知:如何正确求助?哪些是违规求助? 7889341
关于积分的说明 16290831
捐赠科研通 5201903
什么是DOI,文献DOI怎么找? 2783326
邀请新用户注册赠送积分活动 1766075
关于科研通互助平台的介绍 1646904