Extension Study for 2993-112
2015年2月23日 更新者：AstraZeneca
An Open-Label Extension Study of Protocol 2993-112 to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of AC2993 Given Two Times a Day to Subjects Treated With Metformin Alone
This multicenter, open-label extension study of Protocol 2993-112 is designed to assess long-term glucose control as measured by HbA1c (glycosylated hemoglobin) and to evaluate long-term safety and tolerability in subjects treated with metformin who receive subcutaneously injected AC2993 (10 mcg) administered twice daily.
Subjects completing Protocol 2993-112 are eligible to enroll.
研究概览
研究类型
介入性
注册 (实际的)
225
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
-
-
Alberta
-
Calgary、Alberta、加拿大、T3B 0M3
- Calgary Metabolic Education and Research Center
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Edmonton、Alberta、加拿大、T6G 2B7
- Walter McKenzie Health Sciences Centre
-
-
British Columbia
-
Vancouver、British Columbia、加拿大、V6Z 1Y6
- St. Paul's Hospital, Research Services
-
-
Manitoba
-
Winnipeg、Manitoba、加拿大、R3A 1R9
- Health Sciences Center
-
-
Ontario
-
London、Ontario、加拿大、N6A 4V2
- University of Western Ontario
-
-
Quebec
-
Montreal、Quebec、加拿大、H3A 1A1
- McGill Nutrition and Food Science Center
-
Ste. Foy、Quebec、加拿大、G1V 4G2
- Centre Hospitalier
-
-
-
-
Alabama
-
Anniston、Alabama、美国、36207
- Pinnacle Research Group
-
Birmingham、Alabama、美国、35206
- Parkway Medical Center
-
Birmingham、Alabama、美国、35235
- Alabama Clinical Therapeutics
-
Eclectic、Alabama、美国、36024
- Eclectic Family Care
-
Haleyville、Alabama、美国、35565
- Winston Physician Services
-
Hueytown、Alabama、美国、35023
- Simon Williamson Clinic
-
Montgomery、Alabama、美国、36106
- Extended Arm Physicians/ Southern Drug
-
Tallassee、Alabama、美国、36078
- Southern Drug Research Network
-
-
Arizona
-
Chandler、Arizona、美国、85224
- Mesa Center for Clinical Research
-
Mesa、Arizona、美国、85201
- Clinic of Physicians and Surgeons, Ltd.
-
Mesa、Arizona、美国、85204
- ANA Ventures, LLC
-
Phoenix、Arizona、美国、85020
- Physicians at the Peak
-
Phoenix、Arizona、美国、85016
- Lovelace Scientific Resources
-
Tucson、Arizona、美国、85712
- Advanced Clinical Therapeutics
-
-
Arkansas
-
Fayetteville、Arkansas、美国、72701
- First Care Family Doctors
-
Little Rock、Arkansas、美国、72205
- CAVHS
-
Little Rock、Arkansas、美国、72205
- Physicians Group Research Clinic, LLC
-
-
California
-
Anaheim、California、美国、92801
- Advanced Clinical Research Institute
-
Atherton、California、美国、94027
- Endocrine Metabolic Medical Center
-
Bakersfield、California、美国、93309
- Mitchell Research Group, Inc.
-
Burlingame、California、美国、94010
- William Zigrang, M.D.
-
Chula Vista、California、美国、91910
- International Clinical Research Network
-
Colton、California、美国、92324
- Arrowhead Regional Medical Center
-
Concord、California、美国、94520
- East Bay Clinical Trial Center
-
Encino、California、美国、91436
- Medical Group of Encino
-
Fremont、California、美国、94538
- Mowry Clinical Research
-
Fresno、California、美国、93720
- Valley Research
-
Fresno、California、美国、93720-2955
- SARC Research Center
-
Irvine、California、美国、92618
- Irvine Clinical Research Center
-
La Jolla、California、美国、92037
- Whittier Institute for Diabetes
-
Long Beach、California、美国、90806
- Harriman Jones Medical Group
-
Los Gatos、California、美国、95032
- Richard Cherlin, M.D.
-
Modesto、California、美国、95350
- Tushar Modi, M.D.
-
Moreno Valley、California、美国、92553
- Dr. Martinez Medical Clinic
-
Pasadena、California、美国、91105
- Arroyo Seco Medical Group
-
Rancho Mirage、California、美国、92270
- Elke Jost-Vu, M.D.
-
Redwood City、California、美国、94062
- Comprehensive Diabetes-Endocrine Medical Associates
-
San Diego、California、美国、92103
- nTouch
-
San Diego、California、美国、92161
- Veterans Medical Research Foundation
-
San Diego、California、美国、92108
- Radiant Research
-
San Diego、California、美国、92108
- San Diego Endocrine and Medical Clinic
-
San Mateo、California、美国、94401
- Diabetes Research Institute of Mills Peninsula
-
Santa Ana、California、美国、92701
- Advanced Clinical Research Institute
-
Santa Monica、California、美国、90404
- Pacific Clinical Research
-
Signal Hill、California、美国、90755
- West Coast Clinical Trials
-
Vista、California、美国、92083
- Protocare Trials at Sharp Mission Park
-
Walnut Creek、California、美国、94598
- Diablo Clinical Research
-
-
Colorado
-
Denver、Colorado、美国、80262
- University of Colorado-Barbara Davis Center for Childhood Diabetes
-
-
Connecticut
-
Waterbury、Connecticut、美国、06708
- Pheonix International Medicine Associates
-
-
Delaware
-
Newark、Delaware、美国、19713
- Health Core at Health Care Center Christiana
-
-
District of Columbia
-
Washington、District of Columbia、美国、20037
- George Washington University
-
Washington、District of Columbia、美国、20003-4393
- MedStar Clinical Research
-
-
Florida
-
Clearwater、Florida、美国、33765
- Clinical Research of West Florida, Inc.
-
Clearwater、Florida、美国、33756
- Morton Plant Mease Health Care
-
Daytona Beach、Florida、美国、32114
- Atlantic Institute of Clinical Research
-
Daytona Beach、Florida、美国、32114
- Halifax Clinical Research Institute
-
Ft. Myers、Florida、美国、33901
- Internal Medical Associates
-
Gainesville、Florida、美国、32605
- Clin Sci International
-
Gainesville、Florida、美国、32610-0226
- University of FL
-
Hollywood、Florida、美国、33023
- South Florida Clinical Research Center
-
Jacksonville、Florida、美国、32250
- Health Trials 3000
-
Jupiter、Florida、美国、33458
- Jupiter Research Institute
-
Maitland、Florida、美国、32751
- ICSL Clinical Studies
-
Miami、Florida、美国、33176
- Baptist Diabetes Associates
-
New Port Richey、Florida、美国、34652
- Suncoast Clinical Research
-
Orlando、Florida、美国、32801
- VRG Research
-
Palm Harbor、Florida、美国、34684
- Highland Lakes Medical Center
-
Tallahassee、Florida、美国、32308
- Tallahassee Endocrine Associates
-
Tampa、Florida、美国、33614
- Tampa Medical Group
-
Tampa、Florida、美国、33612
- Biostator / USF Diabetes Center
-
Vero Beach、Florida、美国、32967
- Diabetes and Endocrine Associates of the Treasure Co
-
West Palm Beach、Florida、美国、33407
- Radiant Research
-
West Palm Beach、Florida、美国、33401
- Metabolic Research Institute, Inc.
-
-
Georgia
-
Atlanta、Georgia、美国、30342
- Clinical Research Atlanta
-
Atlanta、Georgia、美国、30328
- ICSL-Clinical Studies
-
Columbus、Georgia、美国、31901
- Columbus Metabolic Foundation
-
Decatur、Georgia、美国、30033
- nTouch Research Corporation
-
-
Hawaii
-
Honolulu、Hawaii、美国、96813
- East-West Medical Research Institute
-
Honolulu、Hawaii、美国、96814
- Radiant Research
-
-
Idaho
-
Meridian、Idaho、美国、83642
- St. Luke's Family Health
-
-
Illinois
-
Belvidere、Illinois、美国、61008
- University Primary Care Center at Belvidere
-
Chicago、Illinois、美国、60612
- Cook County Hospital
-
Chicago、Illinois、美国、60610
- Illinois Center for Clinical Trials
-
Chicago、Illinois、美国、60602
- Northwestern Memorail Physicians Group
-
Libertyville、Illinois、美国、60048
- Lake Forest Internal Medicine
-
Libertyville、Illinois、美国、60048
- Winchester Research Group
-
Springfield、Illinois、美国、62703
- Springfield Clinic
-
Springfield、Illinois、美国、62704
- Springfield Diabetes and Endocrinology
-
-
Indiana
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Fort Wayne、Indiana、美国、46804
- Medical Group of Fort Wayne
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Indianapolis、Indiana、美国、46202
- Indiana University Outpatient Clinical Research
-
Indianapolis、Indiana、美国、46222
- American Health Network
-
Indianapolis、Indiana、美国、46260
- Center for Metabolic and Hormonal Disorders
-
South Bend、Indiana、美国、46601
- nTouch Research Corporation
-
-
Iowa
-
Des Moines、Iowa、美国、50314
- Ramona Holiday Diabetes Center
-
Iowa City、Iowa、美国、52242-1009
- Diabetes Clinical Research and Programs
-
-
Kansas
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Kansas City、Kansas、美国、66160
- Lipid, Atherosclerosis & Metabolic Clinic
-
-
Kentucky
-
Lexington、Kentucky、美国、40509
- Central Kentucky Research Associates
-
Lexington、Kentucky、美国、40503
- Kentucky Diabetes Center
-
Lexington、Kentucky、美国、40536-9841
- University of Kentucky Metabolic Research Group
-
Louisville、Kentucky、美国、40223
- MedResearch, Inc.
-
-
Louisiana
-
Metairie、Louisiana、美国、70001
- Drug Research Services
-
New Orleans、Louisiana、美国、70119
- New Orleans Center for Clinical Research
-
New Orleans、Louisiana、美国、70121
- Ochsner Clinic
-
New Orleans、Louisiana、美国、70112
- New Orleans Institute of Clinical Investigation
-
-
Maine
-
Bangor、Maine、美国、04401
- Diabetes, Endocrine and Nutrition Center
-
-
Maryland
-
Baltimore、Maryland、美国、21229
- St. Agnes Health Care
-
Baltimore、Maryland、美国、21201
- VA Medical Center
-
Lanham、Maryland、美国、20706
- Doctors Research Associates of Maryland
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109
- University of Michigan-Endocrinology and Metabolism
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Bloomfield Hills、Michigan、美国、48302
- Grunberger Diabetes Medical Center
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Detroit、Michigan、美国、48202
- Henry Ford Health System
-
Grand Rapids、Michigan、美国、49506
- Grand Rapids Associated Interns
-
Kalamazoo、Michigan、美国、49009
- Westside Family Medical Center
-
-
Minnesota
-
Rochester、Minnesota、美国、55905
- Mayo Clinic, Division of Endocrinology and Metabolism
-
-
Mississippi
-
Jackson、Mississippi、美国、39216
- University of Mississippi Medical Center
-
-
Missouri
-
Chesterfield、Missouri、美国、63017
- Diabetes and Endocrinology Specialists
-
Excelsior Springs、Missouri、美国、64024
- Medical Arts Research Collaborative
-
Kansas City、Missouri、美国、64111
- St Lukes Lipid and Diabetes Research Center
-
Rolla、Missouri、美国、65401
- Mid Missouri Research Specialists, Inc.
-
St. Louis、Missouri、美国、63128
- St. Louis Center for Clinical Research
-
St. Louis、Missouri、美国、63141
- Radiant Research
-
St. Peters、Missouri、美国、63376
- Midwest Pharmaceutical Research
-
-
Montana
-
Butte、Montana、美国、59701
- Mercury Street Medical
-
-
Nebraska
-
Omaha、Nebraska、美国、68131
- Creighton Diabetes Center
-
-
Nevada
-
Las Vegas、Nevada、美国、89102
- Lovelace Scientific Resources
-
Las Vegas、Nevada、美国、89106
- ICSL
-
-
New Hampshire
-
Dover、New Hampshire、美国、03820
- Endocrinology and Diabetes Consultants, P.C.
-
-
New Jersey
-
Jersey City、New Jersey、美国、07306
- HIS Clinical Research
-
Moorestown、New Jersey、美国、08057
- Radiant Research
-
Mt. Laurel、New Jersey、美国、08054
- Matrix Research Institute
-
Passaic、New Jersey、美国、07055
- New Jersey Physicians
-
South Plainfield、New Jersey、美国、07080
- Anderson and Collins Clinical Research, Inc.
-
-
New Mexico
-
Albuquerque、New Mexico、美国、87108
- Lovelace Scientific Resources
-
-
New York
-
Bronx、New York、美国、10467
- Albert Einstein College of Medicine of Yeshiva University
-
Brooklyn、New York、美国、11203
- SUNY Downstate
-
Brooklyn、New York、美国、11230
- Medical Network Services, P.C.
-
Mineola、New York、美国、11501
- Winthrop University Hospital
-
New York、New York、美国、10025
- St. Lukes Roosevelt Hospital
-
New York、New York、美国、10032
- Naomi Berrie Diabetes Center at Columbia University
-
New York、New York、美国、10033
- Heights Medical Care
-
New York、New York、美国、10032
- Irving Diabetes Research Unit at Columbia University
-
Rochester、New York、美国、14609
- Rochester Clinical Research
-
Yonkers、New York、美国、10710
- DOCS at Beth Israel Medical Center
-
-
North Carolina
-
Charlotte、North Carolina、美国、28209
- Metrolina Medical Research
-
Charlotte、North Carolina、美国、28211
- Charlotte Clinical Research
-
Durham、North Carolina、美国、27713
- UNC Diabetes Care Center
-
Hickory、North Carolina、美国、28601
- Unifour Medical Research
-
Wilmington、North Carolina、美国、28412
- New Hanover Medical Research Associates
-
Winston-Salem、North Carolina、美国、27103
- Piedmont Medical Research
-
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Ohio
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Cleveland、Ohio、美国、44124
- Rapid Medical Research
-
Columbus、Ohio、美国、43212
- Radiant Research
-
Columbus、Ohio、美国、43210
- Ohio State University-Division of Endocrinology
-
Mentor、Ohio、美国、44060
- University Mednet
-
Mogadore、Ohio、美国、44260
- Comprehensive Research Services, Inc.
-
Westlake、Ohio、美国、44145
- North Coast Institute of Diabetes and Endocrinology
-
-
Oklahoma
-
Clinton、Oklahoma、美国、73601
- Prime Care Clinical Research
-
Oklahoma City、Oklahoma、美国、73104
- OU Health Sciences Center
-
Oklahoma City、Oklahoma、美国、73103
- Cor Clinical Research
-
Oklahoma City、Oklahoma、美国、73112
- nTouch Research Corporation
-
Tulsa、Oklahoma、美国、74104
- Utica Park Clinic
-
-
Oregon
-
Medford、Oregon、美国、97504
- Medford Medical Clinic
-
Medford、Oregon、美国、97504
- Americas Doctors
-
Portland、Oregon、美国、97232
- Legacy Clinical Research
-
Portland、Oregon、美国、97201
- Radiant Research
-
Portland、Oregon、美国、97210
- Portland Diabetes and Endocrinology Center
-
Portland、Oregon、美国、97214
- Pacific Coast Clinical Coordinators, Inc.
-
-
Pennsylvania
-
Camp Hill、Pennsylvania、美国、17011
- Physicians for Clinical Research
-
Horsham、Pennsylvania、美国、19044-12297
- Argus Research Laboratories
-
Philadelphia、Pennsylvania、美国、19141
- Albert Einstein Medical Center
-
Philadelphia、Pennsylvania、美国、19107
- Thomas Jefferson University Diabetes Research Center
-
Philadelphia、Pennsylvania、美国、19146
- Philadelphia Health Associates
-
Sellersville、Pennsylvania、美国、18960
- Elite Medical Research, Inc.
-
Tipton、Pennsylvania、美国、16684
- Tipton Medical and Diagnostic Center
-
-
Rhode Island
-
East Providence、Rhode Island、美国、02914
- Safe Harbor Clinical Research
-
East Providence、Rhode Island、美国、02915
- ICSL-Providence
-
-
South Carolina
-
Charleston、South Carolina、美国、29407
- Radiant Research
-
Chester、South Carolina、美国、29706
- CNS Clinical Trials
-
Mt. Pleasant、South Carolina、美国、29464
- Coastal Carolina Research Center
-
-
Tennessee
-
Alcoa、Tennessee、美国、37701
- Tennessee Valley Clinical Research Associates
-
Jackson、Tennessee、美国、38305
- Integrity Clinical Research
-
Johnson City、Tennessee、美国、37601
- Harmony Clinical Research
-
Kingsport、Tennessee、美国、37660
- Holston Medical Group
-
Knoxville、Tennessee、美国、37909
- Endocrine Consultants of ET
-
Memphis、Tennessee、美国、38119
- The Endocrine Clinic
-
Milan、Tennessee、美国、38358
- Integrity Clinical Research
-
Nashville、Tennessee、美国、37203
- Mid State Endocrine Associates
-
-
Texas
-
Arlington、Texas、美国、76014
- Israel A. Hartman, M.D.
-
Austin、Texas、美国、78705
- Central Texas Clinical Research
-
Dallas、Texas、美国、75251
- Rafael Canadas M.D., P.A.
-
Dallas、Texas、美国、75230
- Dallas Diabetes and Endocrinology Research Center
-
El Paso、Texas、美国、79905
- Texas Tech University Health Sciences-Internal Medicine
-
El Paso、Texas、美国、79912
- Internal Medicine Associates
-
Fort Worth、Texas、美国、76107
- Lanier Education Research Network
-
Irving、Texas、美国、75038
- North Texas Clinical Research
-
Kingsville、Texas、美国、78363
- Dr. Humberto Bruschetta
-
Lake Jackson、Texas、美国、77566
- R/D Clinical Research, Inc.
-
McAllen、Texas、美国、78503
- South Texas Applied Research
-
San Antonio、Texas、美国、78207
- University of Texas Health Sciences Center-Texas Diabetes Institute
-
San Antonio、Texas、美国、78229-3894
- Diabetes and Glandular Disease Clinic
-
San Antonio、Texas、美国、78205
- Sun Research Institute
-
San Antonio、Texas、美国、78229
- SAM Clinical Research
-
-
Utah
-
Salt Lake City、Utah、美国、84124
- Salt Lake Research
-
Salt Lake City、Utah、美国、84108
- Utah Diabetes Center at the University of Utah
-
-
Virginia
-
Arlington、Virginia、美国、22204
- Medical Associates of Northern Virginia
-
Norfolk、Virginia、美国、23507
- Clinical Research Center-Eastern Virginia Medical School
-
Richmond、Virginia、美国、23225
- Drs. Wigand, Wasserman, and Associates
-
-
Washington
-
Kirkland、Washington、美国、98034
- Evergreen Diabetes & Endocrinology
-
Lacey、Washington、美国、98516
- Olympic Medical Services
-
Olympia、Washington、美国、98502
- West Olympia Internal Medicine
-
Renton、Washington、美国、98055
- Rainier Clinical Research Center
-
Spokane、Washington、美国、99202
- Rockwood Clinic
-
Spokane、Washington、美国、99201
- Northside Internal Medicine
-
Spokane、Washington、美国、99204
- Julia M. Hutchinson, M.D.
-
Wenatchee、Washington、美国、98801
- Wenatchee Valley Clinic
-
-
West Virginia
-
Charleston、West Virginia、美国、25304
- CAMC Clinical Trials Center
-
Charleston、West Virginia、美国、25301
- Hyperion Clinical Research
-
-
Wisconsin
-
Madison、Wisconsin、美国、53711
- University of Wisconsin West Clinic
-
Milwaukee、Wisconsin、美国、53215
- Midwest Endocrinology Associates
-
Milwaukee、Wisconsin、美国、53226
- VRG Research
-
-
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
16年 至 75年 (孩子、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
All of the following criteria are to be fulfilled for inclusion of an individual in the study unless the sponsor grants an exception:
- Has completed the 30-week triple-blind treatment initiation/active treatment periods in Protocol 2993-112, including all procedures required at the study termination visit (Week 30).
- Male or female. Female individuals must be either 1) postmenopausal as documented by serum FSH measurement unless using estrogen for hormone replacement therapy; or 2) of childbearing potential and used appropriate contraceptive methods (surgical sterility or oral, injected, barrier, intrauterine, or implanted contraceptives) for the duration of Protocol 2993-112. This individual must have a current, negative pregnancy test (human chorionic gonadotropin [HCG], beta subunit) regardless of birth control method used. The individual agrees to continue using birth control throughout the study to prevent pregnancy.
- Able to understand and sign a Protocol 2993-112E-specific informed consent form, communicate with the investigator, and understand and comply with the protocol requirements.
Individuals meeting any of the following criteria are to be excluded from the study unless the sponsor grants an exception:
- Has not completed Protocol 2993-112.
- Female individuals who are pregnant, lactating, or planning to become pregnant.
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Open-label AC2993
|
4-Week transition of AC2993 5 mcg subcutaneously injected twice daily followed by an open-ended period through study termination (up to 52 weeks) of AC2993 10 mcg subcutaneously injected twice daily
其他名称：
|
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 |
|---|---|---|
|
Change in HbA1c from Day 1 of Protocol 2993-112 to Week 52 (or termination)
大体时间：Day 1 of study 2993-112 through extension study termination (up to Week 52)
|
Change in HbA1c from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively.
|
Day 1 of study 2993-112 through extension study termination (up to Week 52)
|
|
Change in body weight from Day 1 of Protocol 2993-112 to Week 52 (or termination)
大体时间：Day 1 of study 2993-112 through extension study termination (up to Week 52)
|
Change in body weight (KG) from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively.
|
Day 1 of study 2993-112 through extension study termination (up to Week 52)
|
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
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
2002年9月1日
初级完成 (实际的)
2004年6月1日
研究完成 (实际的)
2004年6月1日
研究注册日期
首次提交
2013年2月11日
首先提交符合 QC 标准的
2013年2月11日
首次发布 (估计)
2013年2月12日
研究记录更新
最后更新发布 (估计)
2015年2月24日
上次提交的符合 QC 标准的更新
2015年2月23日
最后验证
2015年1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.