A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)
2015年3月19日 更新者：AstraZeneca
A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release(Once Weekly) to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone.
The safety and tolerability of the three treatment regimens will also be compared.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
514
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Bangalore、印度
- Research Site
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Indore、印度
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Karnal、印度
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Mumbai、印度
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Pune、印度
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Toluca、墨西哥
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Distrito Federal
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Mexico City、Distrito Federal、墨西哥
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Jalisco
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Guadalajara、Jalisco、墨西哥
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Zapopan、Jalisco、墨西哥
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Morelos
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Cuernavaca、Morelos、墨西哥
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NuevoLeon
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Monterrey、NuevoLeon、墨西哥
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Arizona
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Peoria、Arizona、美国
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California
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Artesia、California、美国
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Concord、California、美国
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Encino、California、美国
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Greenbrae、California、美国
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La Mesa、California、美国
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Orange、California、美国
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Walnut Creek、California、美国
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Whittier、California、美国
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Colorado
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Colorado Springs、Colorado、美国
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District of Columbia
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Washington、District of Columbia、美国
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Florida
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Coral Gables、Florida、美国
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Deland、Florida、美国
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Melbourne、Florida、美国
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Miami、Florida、美国
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New Port Richey、Florida、美国
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Georgia
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Decatur、Georgia、美国
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Indiana
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Avon、Indiana、美国
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Kansas
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Wichita、Kansas、美国
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Kentucky
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Paducah、Kentucky、美国
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Louisiana
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Baton Rouge、Louisiana、美国
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New Orleans、Louisiana、美国
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Maryland
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Oxon Hill、Maryland、美国
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Massachusetts
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Boston、Massachusetts、美国
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Michigan
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Chelsea、Michigan、美国
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Ypsilanti、Michigan、美国
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Minnesota
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St. Louis Park、Minnesota、美国
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Missouri
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St. Louis、Missouri、美国
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Montana
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Butte、Montana、美国
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Nebraska
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Lincoln、Nebraska、美国
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Nevada
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Las Vegas、Nevada、美国
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New York
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New Hyde Park、New York、美国
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New Windsor、New York、美国
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New York、New York、美国
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Rochester、New York、美国
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North Carolina
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Durham、North Carolina、美国
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Statesville、North Carolina、美国
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Winston-Salem、North Carolina、美国
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Ohio
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Athens、Ohio、美国
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Cincinnati、Ohio、美国
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Dayton、Ohio、美国
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Pennsylvania
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Philadelphia、Pennsylvania、美国
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South Dakota
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Rapid City、South Dakota、美国
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Tennessee
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Memphis、Tennessee、美国
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Texas
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Austin、Texas、美国
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Dallas、Texas、美国
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San Antonio、Texas、美国
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Virginia
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Richmond、Virginia、美国
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Washington
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Olympia、Washington、美国
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Spokane、Washington、美国
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Tacoma、Washington、美国
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Has been diagnosed with type 2 diabetes mellitus
- Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start
- Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
- Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start
Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:
- Hormone replacement therapy (female subjects)
- Oral contraceptives (female subjects)
- Antihypertensive agents
- Lipid-lowering agents
- Thyroid replacement therapy
- Antidepressant agents
- Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over-the-counter antiobesity agents
Exclusion Criteria:
- Has been previously exposed to exenatide once weekly
- Has donated blood within 60 days of study start or is planning to donate blood during the study
Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:
- Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3 months prior to study start
- Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start
- Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start
- Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
- Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®) and rifampin
- Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
- Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：1个
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皮下注射，2.0mg，每周一次
oral tablet, once a day
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有源比较器：2个
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oral tablet, 100mg, once a day
其他名称：
subcutaneous injection, once a week
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有源比较器：3个
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subcutaneous injection, once a week
oral tablet, 45mg, once a day
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in HbA1c From Baseline to Week 26
大体时间：Day 1, Week 26
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Absolute change in HbA1c from baseline (Day 1) to Week 26 [Week 26 - Baseline].
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Day 1, Week 26
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Subjects Achieving HbA1c Target of <7% at Week 26
大体时间：Week 26
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Percentages of subjects achieving HbA1c target values of <7% at Week 26.
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Week 26
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Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26
大体时间：Week 26
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Percentages of subjects achieving HbA1c target values of <=6.5% at Week 26.
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Week 26
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Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26
大体时间：Week 26
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Percentages of subjects achieving HbA1c target values of <=6.0% at Week 26.
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Week 26
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Change in Body Weight From Baseline to Week 26
大体时间：Day 1, Week 26
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Change in body weight from baseline (Day 1) to Week 26.
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Day 1, Week 26
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Change in Fasting Plasma Glucose From Baseline to Week 26
大体时间：Day 1, Week 26
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Change in fasting plasma glucose from baseline (Day 1) to Week 26.
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Day 1, Week 26
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Change in Systolic Blood Pressure From Baseline to Week 26
大体时间：Day 1, Week 26
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Change in systolic blood pressure from baseline (Day 1) to Week 26.
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Day 1, Week 26
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Change in Diastolic Blood Pressure From Baseline to Week 26
大体时间：Day 1, Week 26
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Change in diastolic blood pressure from baseline (Day 1) to Week 26.
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Day 1, Week 26
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Change in Fasting Total Cholesterol From Baseline to Week 26
大体时间：Day 1, Week 26
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Change in fasting total cholesterol from baseline (Day 1) to Week 26.
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Day 1, Week 26
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Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26
大体时间：Day 1, Week 26
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Change in fasting HDL from baseline (Day 1) to Week 26.
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Day 1, Week 26
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Ratio of Fasting Triglycerides at Week 26 to Baseline
大体时间：Day 1, Week 26
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Ratio of triglycerides (measured in mg/dL) at Week 26 to baseline (Day 1).
Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
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Day 1, Week 26
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Assessment on Event Rate of Treatment-emergent Hypoglycemic Events
大体时间：Day 1 to Week 26
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Major hypoglycemia: events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration < 54 mg/dL prior to treatment.
Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration < 54 mg/dL prior to treatment and not classified as major hypoglycemia.
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Day 1 to Week 26
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
- Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.
- Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18. Erratum In: Diabetes Ther. 2020 Dec;11(12):3011-3013.
- Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48.
- Peyrot M, Bushnell DM, Best JH, Martin ML, Cameron A, Patrick DL. Development and validation of the self-management profile for type 2 diabetes (SMP-T2D). Health Qual Life Outcomes. 2012 Oct 5;10:125. doi: 10.1186/1477-7525-10-125.
- Malloy J, Meloni A, Han J. Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data. Postgrad Med. 2013 May;125(3):58-67. doi: 10.3810/pgm.2013.05.2661.
- Wysham C, Bergenstal R, Malloy J, Yan P, Walsh B, Malone J, Taylor K. DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide. Diabet Med. 2011 Jun;28(6):705-14. doi: 10.1111/j.1464-5491.2011.03301.x.
- Bergenstal RM, Wysham C, Macconell L, Malloy J, Walsh B, Yan P, Wilhelm K, Malone J, Porter LE; DURATION-2 Study Group. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet. 2010 Aug 7;376(9739):431-9. doi: 10.1016/S0140-6736(10)60590-9. Epub 2010 Jun 26.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年1月1日
初级完成 (实际的)
2009年2月1日
研究完成 (实际的)
2009年7月1日
研究注册日期
首次提交
2008年3月6日
首先提交符合 QC 标准的
2008年3月10日
首次发布 (估计)
2008年3月17日
研究记录更新
最后更新发布 (估计)
2015年4月7日
上次提交的符合 QC 标准的更新
2015年3月19日
最后验证
2015年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.