Glycemic Reduction Approaches for Treating Diabetes: An Effectiveness Study

治疗糖尿病的降血糖方法:有效性研究

基本信息

  • 批准号:
    8152144
  • 负责人:
  • 金额:
    $ 30.9万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2010
  • 资助国家:
    美国
  • 起止时间:
    2010-09-28 至 2012-11-30
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): The epidemic of type 2 diabetes (T2DM) that has affected the US and other populations in the last thirty years is a major public health problem. The most recent US estimates include a prevalence of more than 21 million and incidence of 1.6 million cases per year. The major human and economic costs associated with the epidemic are related primarily to the development of long-term complications that cause more cases of blindness, renal failure, and amputations than any other disease. T2DM also increases cardiovascular disease by 2-5 fold and is the leading cause of death and premature death in persons with diabetes. High quality clinical trials have established the importance of lowering glycemia with a variety of medications to reduce the long-term complications. One of the major challenges for practitioners is to choose, from the large armamentarium of glucose-lowering medications at their disposal, the optimal approach to achieve and then maintain good glycemic control for as long as possible. Evidence supporting the choice of one versus another agent as initial therapy or the choice of sequential versus combination therapy as an initial approach is clearly lacking. Comparative effectiveness research is a high priority to improve public health and maximize cost- effectiveness. Moreover, there are little data available to determine whether some therapies work better in individuals with particular characteristics compared to others; therefore, individualizing therapies to obtain maximum effectiveness remains in its infancy. We propose to address these questions in a randomized clinical trial in patients with recent onset (<3 years duration) T2DM that will compare the metabolic effects of five common glucose- lowering drugs when combined with metformin. Recruitment will be stratified to include patients who have been treated with metformin (n=5,500) for up to three years, and patients who are drug-naive (n=2,000). All will be randomly assigned to one of five drug regimens to be administered in combination with metformin. Subjects in the drug naive stratum will also be randomly assigned to be treated with the assigned drug as sequential therapy (ST) after glycemic control has deteriorated with metformin monotherapy, similar to traditional prescribing patterns, or to receive initial combination therapy (ICT). The one-half of the drug-naive stratum assigned to initial combination therapy will be included with the metformin-treated stratum in the analyses of the differences among the five drug combinations. The proposed partial factorial design is an efficient way to compare the five major diabetes drug combinations and examine two different treatment strategies in a single trial. The primary metabolic outcome will be time to failure defined as a HbA1c >7%, with area- under-the-curve HbA1c levels as a secondary metabolic outcome. Follow-up will be for a minimum of 4 (4-7) years. Determination and comparison of the other important attributes of the five combinations, including weight change, hypoglycemia, tolerability, effects on CVD risk factors, and cost will be performed. In addition, we will examine the phenotypic and, resources permitting, genotypic characteristics that are associated with metabolic response to and/or failure of the individual medication combinations and the two intervention strategies. The goal of the proposed U34 application is to complete the design and prepare for the implementation of a multicenter study to determine the most effective drug combinations and treatment strategies for T2DM that achieve and maintain the glycemic levels known to reduce long-term complications. Specifically, the U34 period will be used to: a) develop the protocol and manual of operations; b) recruit the clinical centers, laboratories, and reading and drug distribution centers; and c) establish recruitment strategies, identify patient populations and complete the IRB and other regulatory approval process to meet enrollment timelines. This preparation will ensure that the majority of clinical sites are ready to start randomizing patients as soon as possible after the study is funded, minimizing recruitment time and maximizing patient follow-up and power of the study. The results of this trial will identify the most effective means of treating glycemia in T2DM early in its course and will have major public health implications. PUBLIC HEALTH RELEVANCE: In order to avoid long-term complications that may affect people with type 2 diabetes, average blood sugar levels, as measured with the HbA1c assay, must be maintained in a near-normal range. Although there are many medications that are currently available to treat type 2 diabetes, we don't understand the most effective means of achieving and maintaining the target blood sugar levels over time. In addition, we don't know whether specific medications, or combinations of medications, are better for specific groups of people. The proposed study will compare two different strategies and five different medications for treating type 2 diabetes in order to determine how best to treat it. Since type 2 diabetes is now epidemic, affecting more than 20 million people in the US, comparing and selecting the most effective treatment methods will have a major public health impact.
描述(由申请人提供):2型糖尿病(T2 DM)的流行在过去30年里影响了美国和其他人口,是一个主要的公共卫生问题。美国的最新估计包括患病率超过2100万,每年的发病率为160万例。与疫情相关的重大人力和经济代价主要与长期并发症的发展有关,这些并发症导致的失明、肾功能衰竭和截肢病例比任何其他疾病都多。2型糖尿病还会使心血管疾病增加2-5倍,是糖尿病患者死亡和过早死亡的主要原因。高质量的临床试验已经证实了通过各种药物降低血糖以减少长期并发症的重要性。从业者面临的主要挑战之一是从他们可支配的大量降糖药物中选择最佳的方法来实现并尽可能长时间地保持良好的血糖控制。显然缺乏支持选择一种或另一种药物作为初始治疗或选择序贯或联合治疗作为初始方法的证据。比较有效性研究是改善公共健康和最大限度提高成本效益的高度优先事项。此外,几乎没有可用的数据来确定某些疗法在具有特定特征的个人身上是否比其他疗法效果更好;因此,为获得最大疗效而进行个体化治疗仍处于起步阶段。 我们建议在一项针对新近发病(病程3年)的T2 DM患者的随机临床试验中解决这些问题,该试验将比较五种常见降糖药物与二甲双胍联合使用时的代谢影响。招募将被分层,包括接受二甲双胍治疗长达三年的患者(n=5500),以及未服用药物的患者(n=2,000)。所有患者将被随机分配到五种药物方案中的一种,与二甲双胍联合使用。与传统的处方模式类似,药物初级层的受试者也将被随机分配到血糖控制恶化后接受指定药物作为序贯治疗(ST)的患者,或接受初始联合治疗(ICT)。在分析五种药物组合之间的差异时,将分配给初始联合治疗的药物初级层的一半与二甲双胍治疗组一起包括在内。建议的部分析因设计是比较五种主要糖尿病药物组合并在一次试验中检查两种不同治疗策略的有效方法。 主要代谢结果将是失效时间,定义为HbA1c&gt;7%,曲线下面积HbA1c水平为次要代谢结果。随访期至少为4(4-7)年。将确定和比较这五种组合的其他重要属性,包括体重变化、低血糖、耐受性、对心血管疾病危险因素的影响和成本。此外,在资源允许的情况下,我们将研究与单独用药组合和两种干预策略的代谢反应和/或失败相关的表型和遗传型特征。 建议的U34应用程序的目标是完成设计并为实施一项多中心研究做准备,以确定达到并保持已知可减少长期并发症的血糖水平的T2 DM最有效的药物组合和治疗策略。具体地说,U34期间将用于:a)制定操作规程和手册;b)招募临床中心、实验室以及阅读和药品分销中心;c)制定招募战略,确定患者群体,并完成IRB和其他监管批准程序,以满足登记时间表。这项准备将确保大多数临床站点在研究获得资金后尽快开始随机选择患者,最大限度地减少招募时间,并最大限度地提高患者随访和研究的力量。这项试验的结果将确定治疗2型糖尿病早期血糖的最有效方法,并将对公众健康产生重大影响。 公共卫生相关性:为了避免可能影响2型糖尿病患者的长期并发症,HbA1c测定的平均血糖水平必须保持在接近正常的范围内。尽管目前有许多药物可用于治疗2型糖尿病,但我们并不了解在一段时间内达到并保持目标血糖水平的最有效方法。此外,我们不知道特定药物或药物组合对特定人群更好。这项拟议的研究将对治疗2型糖尿病的两种不同策略和五种不同药物进行比较,以确定如何最好地治疗它。由于2型糖尿病目前在美国流行,影响着2000多万人,比较和选择最有效的治疗方法将对公共卫生产生重大影响。

项目成果

期刊论文数量(0)
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DAVID M NATHAN其他文献

DAVID M NATHAN的其他文献

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{{ truncateString('DAVID M NATHAN', 18)}}的其他基金

Glycemic Reduction Approaches for Treating Diabetes: An Effectiveness Study
治疗糖尿病的降血糖方法:有效性研究
  • 批准号:
    8113503
  • 财政年份:
    2010
  • 资助金额:
    $ 30.9万
  • 项目类别:
LOOK AHEAD: ACTION FOR HEALTH IN DIABETES
展望未来:糖尿病健康行动
  • 批准号:
    7731311
  • 财政年份:
    2008
  • 资助金额:
    $ 30.9万
  • 项目类别:
CLINICAL TRIAL: TODAY
临床试验:今天
  • 批准号:
    7731247
  • 财政年份:
    2008
  • 资助金额:
    $ 30.9万
  • 项目类别:
CLINICAL TRIAL: DIABETES PREVENTION PROGRAM OUTCOMES STUDY (DPPOS)
临床试验:糖尿病预防计划结果研究 (DPPOS)
  • 批准号:
    7731238
  • 财政年份:
    2008
  • 资助金额:
    $ 30.9万
  • 项目类别:
TREATMENT OPTIONS FOR TYPE 2 DIABETES IN ADOLESCENTS AND YOUTH (TODAY)
青少年 2 型糖尿病的治疗方案(当今)
  • 批准号:
    7731316
  • 财政年份:
    2008
  • 资助金额:
    $ 30.9万
  • 项目类别:
COMPARISON OF LANTUS AND NPH INSULIN IN THE DAWN PHENOMENON
来得时和 NPH 胰岛素在黎明现象中的比较
  • 批准号:
    7731271
  • 财政年份:
    2008
  • 资助金额:
    $ 30.9万
  • 项目类别:
TODAY
今天
  • 批准号:
    7607048
  • 财政年份:
    2006
  • 资助金额:
    $ 30.9万
  • 项目类别:
LOOK AHEAD: ACTION FOR HEALTH IN DIABETES
展望未来:糖尿病健康行动
  • 批准号:
    7607103
  • 财政年份:
    2006
  • 资助金额:
    $ 30.9万
  • 项目类别:
TREATMENT OPTIONS FOR TYPE 2 DIABETES IN ADOLESCENTS AND YOUTH (TODAY)
青少年 2 型糖尿病的治疗方案(当今)
  • 批准号:
    7607110
  • 财政年份:
    2006
  • 资助金额:
    $ 30.9万
  • 项目类别:
DIABETES PREVENTION PROGRAM OUTCOMES STUDY (DPPOS)
糖尿病预防计划成果研究 (DPPOS)
  • 批准号:
    7607036
  • 财政年份:
    2006
  • 资助金额:
    $ 30.9万
  • 项目类别:

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