A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus
2019年5月20日 更新者:Astellas Pharma Inc
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Patients With Type 2 Diabetes Mellitus
Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus.
研究概览
研究类型
介入性
注册 (实际的)
412
阶段
- 阶段2
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、560010
- Diacon Hospital
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Ghaziabad、印度、201002
- Hormone Care and Research Centre
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Indore、印度、452001
- TOTALL Diabetes Hormone Institute Pvt.Ltd.
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Jaipur、印度、302001
- S R Kalla Memorial Gastro & General Hospital
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Karnal、印度、132001
- Bride, Bharti Hospital
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Kerala、印度、682041
- Amrita Institute of Medical Sciences and Research Centre, AIMS
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Barranquilla、哥伦比亚
- BIOMELAB
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Barranquilla、哥伦比亚
- Centro de Reumatologia y Ortopedia
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Barranquilla、哥伦比亚
- Fundacion de Caribe para le Investigacion Biomedica
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Bogota、哥伦比亚
- Dexa Diad Servicios Medicos
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Bogota、哥伦比亚
- School of Medicine University of Rosario
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Floridablanca Santander、哥伦比亚
- Fundacion Cardiovascular de Columbia
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Cuernavaca、墨西哥、62250
- Unidad Metabólica y Cardiovascular, SC.
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Guadalajara、墨西哥、44100
- Instituto Jaliscience de Investigacion Clinica
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Guadalajara、墨西哥、44670
- Torre Medica Providencia
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Merida、墨西哥、97070
- Medical Care and Research
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Merida、墨西哥、97129
- CEDIME, Instituto Vascular
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Monterrey、墨西哥、66460
- Hospital Universitario Dr. Eleuterio Gonzalez
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Alabama
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Birmingham、Alabama、美国、35215
- Parkway Medical Center
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Haleyville、Alabama、美国、35565
- Winston Technology Research, LLC
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Arizona
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Mesa、Arizona、美国、85213
- Desert Clinical Research
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Phoenix、Arizona、美国、85020
- Central Phoenix Medical Clinic
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Arkansas
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Pine Bluff、Arkansas、美国、71603
- Paul W. Davis, MD, PA
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California
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Costa Mesa、California、美国、92626
- Clinical Innovations, Inc.
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Huntington Park、California、美国、90255
- Del Rosario Medical Clinic, Inc
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Lomita、California、美国、90717
- Torrance Clinical Research
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San Diego、California、美国、92128
- San Diego Managed Care Group Clinical Research
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Colorado
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Colorado Springs、Colorado、美国、80909
- Expresscare Clinical Research
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Florida
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Brandon、Florida、美国、33511
- PAB Clinical Research
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Coral Gables、Florida、美国、33131
- Clinical Therapeutics Corp.
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Hialeah、Florida、美国、33012
- A.G.A Clinical Trials DBA Neostart Group
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New Port Richey、Florida、美国、34652
- Suncoast Clinical Research
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Georgia
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Augusta、Georgia、美国、30909
- CSRA Partners in Health, Inc.
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Tucker、Georgia、美国、30084
- Atlanta Vascular Research Foundation, Atlanta Cardiology & Primary Care P.C.
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Illinois
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Chicago、Illinois、美国、60607
- Cedar Crosse Research Center
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Chicago、Illinois、美国、60616
- Apex Medical Research, AMR, Inc
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Indiana
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Evansville、Indiana、美国、47714
- MediSphere Medical Research
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Maryland
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Towson、Maryland、美国、21204
- Bay West Endocrinology
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Minnesota
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Saint Paul、Minnesota、美国、55114
- Prism Research
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North Carolina
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Charlotte、North Carolina、美国、28209
- PMG Research of Charlotte, LLC
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Salisbury、North Carolina、美国、28144
- PMG Research of Salisbury, LLC
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Ohio
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Cleveland、Ohio、美国、44122
- Rapid Medical Research
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Zanesville、Ohio、美国、43701
- Primecare of Southeastern Ohio, Inc.
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Oklahoma
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Yukon、Oklahoma、美国、73099
- Integris Family Care
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Oregon
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Eugene、Oregon、美国、97404
- Willamette Valley Clinical Studies
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Pennsylvania
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Fleetwood、Pennsylvania、美国、19522
- Fleetwood Clinical Research
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South Carolina
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Taylors、South Carolina、美国、29687
- Southeastern Research Associates, Inc.
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Tennessee
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Bristol、Tennessee、美国、37620
- PMG Research of Bristol, LLC
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Kingsport、Tennessee、美国、37660
- Holston Medical Group
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Memphis、Tennessee、美国、38125
- Southwind Medical Specialist
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Texas
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Carrollton、Texas、美国、75006
- Punzi Medical Center
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Corpus Christi、Texas、美国、78414
- Corpus Christi Family Wellness Center
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Houston、Texas、美国、77081
- Excel Clinical Research, LLC
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San Antonio、Texas、美国、78229
- Cetero Research
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Utah
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Orem、Utah、美国、84058
- Aspen Clinical Research
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Cebu、菲律宾、6000
- Cebu Doctors' University Hospital
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Iloilo City、菲律宾、5000
- St. Paul's Hospital
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Marikina City、菲律宾、1800
- Amang Rodriguez Memorial Medical Center
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Pasay City、菲律宾、1300
- San Juan de Dios Hospital
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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:
- Subject has been diagnosed with type 2 diabetes
- Subject has a HbA1c value between 6.8 and 9.5%
- Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti- diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study
- Subject is on a stable diet and exercise program
- Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study
Exclusion Criteria:
- Subject has type 1 diabetes mellitus
- Subject is using insulin therapy
- Subject has a serum creatinine higher than upper limit of normal
- Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal
- Subject has persistent, uncontrolled severe hypertension as indicated by a
systolic blood pressure >180 mmHg or a diastolic blood pressure of
>110mmHg
- Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) in the last 3 months
- Subject is known to have hepatitis or be a carrier of hepatitis B surface
antigen, hepatitis C virus antibody or is known positive for HIV1 and/or
HIV2
- Subject has a history of lactic acidosis
- Subject has a history of drug and alcohol abuse/dependency within last 12
months
- Subject has had a malignancy in the last 5 years, except for successfully
treated basal or squamous cell carcinoma of the skin or of the cervix
- Subject has a symptomatic urinary tract infection or genital infection
- Female subject is lactating
- Subject has an unstable medical or psychiatric illness
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:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:ASP1941 lowest dose
oral tablet
|
oral tablet
其他名称:
|
实验性的:ASP1941 low dose
oral tablet
|
oral tablet
其他名称:
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实验性的:ASP1941 high dose
oral tablet
|
oral tablet
其他名称:
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实验性的:ASP1941 highest dose
oral tablet
|
oral tablet
其他名称:
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有源比较器:Metformin
oral tablet
|
oral tablet
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安慰剂比较:Placebo
oral tablet
|
口服片剂
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Mean change from baseline in Hemoglobin A1c (HbA1c)
大体时间:12 weeks
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12 weeks
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次要结果测量
结果测量 |
大体时间 |
---|---|
Mean change from baseline in fasting plasma glucose (FPG)
大体时间:12 weeks
|
12 weeks
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Proportion of subjects achieving target goal of HbA1c <7.0%
大体时间:12 weeks
|
12 weeks
|
Proportion of subjects achieving target goal of HbA1c <6.5%
大体时间:12 weeks
|
12 weeks
|
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。
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
- Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.
- Fonseca VA, Ferrannini E, Wilding JP, Wilpshaar W, Dhanjal P, Ball G, Klasen S. Active- and placebo-controlled dose-finding study to assess the efficacy, safety, and tolerability of multiple doses of ipragliflozin in patients with type 2 diabetes mellitus. J Diabetes Complications. 2013 May-Jun;27(3):268-73. doi: 10.1016/j.jdiacomp.2012.11.005. Epub 2012 Dec 29.
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 (实际的)
2010年3月3日
初级完成 (实际的)
2011年4月11日
研究完成 (实际的)
2011年4月11日
研究注册日期
首次提交
2010年2月18日
首先提交符合 QC 标准的
2010年2月18日
首次发布 (估计)
2010年2月19日
研究记录更新
最后更新发布 (实际的)
2019年5月24日
上次提交的符合 QC 标准的更新
2019年5月20日
最后验证
2019年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 1941-CL-0004
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development.
Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared.
Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD 共享时间框架
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD 共享访问标准
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data.
The research proposal is reviewed by an Independent Research Panel.
If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
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.
安慰剂的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动,不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病,BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病,BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的