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Extension Study for 2993-112

23. februar 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

225

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 0M3
        • Calgary Metabolic Education and Research Center
      • Edmonton, Alberta, Canada, T6G 2B7
        • Walter McKenzie Health Sciences Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital, Research Services
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Health Sciences Center
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • University of Western Ontario
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • McGill Nutrition and Food Science Center
      • Ste. Foy, Quebec, Canada, G1V 4G2
        • Centre hospitalier
  • Forenede Stater
    • Alabama
      • Anniston, Alabama, Forenede Stater, 36207
        • Pinnacle Research Group
      • Birmingham, Alabama, Forenede Stater, 35206
        • Parkway Medical Center
      • Birmingham, Alabama, Forenede Stater, 35235
        • Alabama Clinical Therapeutics
      • Eclectic, Alabama, Forenede Stater, 36024
        • Eclectic Family Care
      • Haleyville, Alabama, Forenede Stater, 35565
        • Winston Physician Services
      • Hueytown, Alabama, Forenede Stater, 35023
        • Simon Williamson Clinic
      • Montgomery, Alabama, Forenede Stater, 36106
        • Extended Arm Physicians/ Southern Drug
      • Tallassee, Alabama, Forenede Stater, 36078
        • Southern Drug Research Network
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85224
        • Mesa Center for Clinical Research
      • Mesa, Arizona, Forenede Stater, 85201
        • Clinic of Physicians and Surgeons, Ltd.
      • Mesa, Arizona, Forenede Stater, 85204
        • ANA Ventures, LLC
      • Phoenix, Arizona, Forenede Stater, 85020
        • Physicians at the Peak
      • Phoenix, Arizona, Forenede Stater, 85016
        • Lovelace Scientific Resources
      • Tucson, Arizona, Forenede Stater, 85712
        • Advanced Clinical Therapeutics
    • Arkansas
      • Fayetteville, Arkansas, Forenede Stater, 72701
        • First Care Family Doctors
      • Little Rock, Arkansas, Forenede Stater, 72205
        • CAVHS
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Physicians Group Research Clinic, LLC
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Advanced Clinical Research Institute
      • Atherton, California, Forenede Stater, 94027
        • Endocrine Metabolic Medical Center
      • Bakersfield, California, Forenede Stater, 93309
        • Mitchell Research Group, Inc.
      • Burlingame, California, Forenede Stater, 94010
        • William Zigrang, M.D.
      • Chula Vista, California, Forenede Stater, 91910
        • International Clinical Research Network
      • Colton, California, Forenede Stater, 92324
        • Arrowhead Regional Medical Center
      • Concord, California, Forenede Stater, 94520
        • East Bay Clinical Trial Center
      • Encino, California, Forenede Stater, 91436
        • Medical Group of Encino
      • Fremont, California, Forenede Stater, 94538
        • Mowry Clinical Research
      • Fresno, California, Forenede Stater, 93720
        • Valley Research
      • Fresno, California, Forenede Stater, 93720-2955
        • SARC Research Center
      • Irvine, California, Forenede Stater, 92618
        • Irvine Clinical Research Center
      • La Jolla, California, Forenede Stater, 92037
        • Whittier Institute for Diabetes
      • Long Beach, California, Forenede Stater, 90806
        • Harriman Jones Medical Group
      • Los Gatos, California, Forenede Stater, 95032
        • Richard Cherlin, M.D.
      • Modesto, California, Forenede Stater, 95350
        • Tushar Modi, M.D.
      • Moreno Valley, California, Forenede Stater, 92553
        • Dr. Martinez Medical Clinic
      • Pasadena, California, Forenede Stater, 91105
        • Arroyo Seco Medical Group
      • Rancho Mirage, California, Forenede Stater, 92270
        • Elke Jost-Vu, M.D.
      • Redwood City, California, Forenede Stater, 94062
        • Comprehensive Diabetes-Endocrine Medical Associates
      • San Diego, California, Forenede Stater, 92103
        • nTouch
      • San Diego, California, Forenede Stater, 92161
        • Veterans Medical Research Foundation
      • San Diego, California, Forenede Stater, 92108
        • Radiant Research
      • San Diego, California, Forenede Stater, 92108
        • San Diego Endocrine and Medical Clinic
      • San Mateo, California, Forenede Stater, 94401
        • Diabetes Research Institute of Mills Peninsula
      • Santa Ana, California, Forenede Stater, 92701
        • Advanced Clinical Research Institute
      • Santa Monica, California, Forenede Stater, 90404
        • Pacific Clinical Research
      • Signal Hill, California, Forenede Stater, 90755
        • West Coast Clinical Trials
      • Vista, California, Forenede Stater, 92083
        • Protocare Trials at Sharp Mission Park
      • Walnut Creek, California, Forenede Stater, 94598
        • Diablo Clinical Research
    • Colorado
      • Denver, Colorado, Forenede Stater, 80262
        • University of Colorado-Barbara Davis Center for Childhood Diabetes
    • Connecticut
      • Waterbury, Connecticut, Forenede Stater, 06708
        • Pheonix International Medicine Associates
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • Health Core at Health Care Center Christiana
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20037
        • George Washington University
      • Washington, District of Columbia, Forenede Stater, 20003-4393
        • MedStar Clinical Research
    • Florida
      • Clearwater, Florida, Forenede Stater, 33765
        • Clinical Research of West Florida, Inc.
      • Clearwater, Florida, Forenede Stater, 33756
        • Morton Plant Mease Health Care
      • Daytona Beach, Florida, Forenede Stater, 32114
        • Atlantic Institute of Clinical Research
      • Daytona Beach, Florida, Forenede Stater, 32114
        • Halifax Clinical Research Institute
      • Ft. Myers, Florida, Forenede Stater, 33901
        • Internal Medical Associates
      • Gainesville, Florida, Forenede Stater, 32605
        • Clin Sci International
      • Gainesville, Florida, Forenede Stater, 32610-0226
        • University of FL
      • Hollywood, Florida, Forenede Stater, 33023
        • South Florida Clinical Research Center
      • Jacksonville, Florida, Forenede Stater, 32250
        • Health Trials 3000
      • Jupiter, Florida, Forenede Stater, 33458
        • Jupiter Research Institute
      • Maitland, Florida, Forenede Stater, 32751
        • ICSL Clinical Studies
      • Miami, Florida, Forenede Stater, 33176
        • Baptist Diabetes Associates
      • New Port Richey, Florida, Forenede Stater, 34652
        • Suncoast Clinical Research
      • Orlando, Florida, Forenede Stater, 32801
        • VRG Research
      • Palm Harbor, Florida, Forenede Stater, 34684
        • Highland Lakes Medical Center
      • Tallahassee, Florida, Forenede Stater, 32308
        • Tallahassee Endocrine Associates
      • Tampa, Florida, Forenede Stater, 33614
        • Tampa Medical Group
      • Tampa, Florida, Forenede Stater, 33612
        • Biostator / USF Diabetes Center
      • Vero Beach, Florida, Forenede Stater, 32967
        • Diabetes and Endocrine Associates of the Treasure Co
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Radiant Research
      • West Palm Beach, Florida, Forenede Stater, 33401
        • Metabolic Research Institute, Inc.
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Clinical Research Atlanta
      • Atlanta, Georgia, Forenede Stater, 30328
        • ICSL-Clinical Studies
      • Columbus, Georgia, Forenede Stater, 31901
        • Columbus Metabolic Foundation
      • Decatur, Georgia, Forenede Stater, 30033
        • nTouch Research Corporation
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • East-West Medical Research Institute
      • Honolulu, Hawaii, Forenede Stater, 96814
        • Radiant Research
    • Idaho
      • Meridian, Idaho, Forenede Stater, 83642
        • St. Luke's Family Health
    • Illinois
      • Belvidere, Illinois, Forenede Stater, 61008
        • University Primary Care Center at Belvidere
      • Chicago, Illinois, Forenede Stater, 60612
        • Cook County Hospital
      • Chicago, Illinois, Forenede Stater, 60610
        • Illinois Center for Clinical Trials
      • Chicago, Illinois, Forenede Stater, 60602
        • Northwestern Memorail Physicians Group
      • Libertyville, Illinois, Forenede Stater, 60048
        • Lake Forest Internal Medicine
      • Libertyville, Illinois, Forenede Stater, 60048
        • Winchester Research Group
      • Springfield, Illinois, Forenede Stater, 62703
        • Springfield Clinic
      • Springfield, Illinois, Forenede Stater, 62704
        • Springfield Diabetes and Endocrinology
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46804
        • Medical Group of Fort Wayne
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University Outpatient Clinical Research
      • Indianapolis, Indiana, Forenede Stater, 46222
        • American Health Network
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Center for Metabolic and Hormonal Disorders
      • South Bend, Indiana, Forenede Stater, 46601
        • nTouch Research Corporation
    • Iowa
      • Des Moines, Iowa, Forenede Stater, 50314
        • Ramona Holiday Diabetes Center
      • Iowa City, Iowa, Forenede Stater, 52242-1009
        • Diabetes Clinical Research and Programs
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Lipid, Atherosclerosis & Metabolic Clinic
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509
        • Central Kentucky Research Associates
      • Lexington, Kentucky, Forenede Stater, 40503
        • Kentucky Diabetes Center
      • Lexington, Kentucky, Forenede Stater, 40536-9841
        • University of Kentucky Metabolic Research Group
      • Louisville, Kentucky, Forenede Stater, 40223
        • MedResearch, Inc.
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70001
        • Drug Research Services
      • New Orleans, Louisiana, Forenede Stater, 70119
        • New Orleans Center for Clinical Research
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Clinic
      • New Orleans, Louisiana, Forenede Stater, 70112
        • New Orleans Institute of Clinical Investigation
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • Diabetes, Endocrine and Nutrition Center
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21229
        • St. Agnes Health Care
      • Baltimore, Maryland, Forenede Stater, 21201
        • VA Medical Center
      • Lanham, Maryland, Forenede Stater, 20706
        • Doctors Research Associates of Maryland
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan-Endocrinology and Metabolism
      • Bloomfield Hills, Michigan, Forenede Stater, 48302
        • Grunberger Diabetes Medical Center
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Health System
      • Grand Rapids, Michigan, Forenede Stater, 49506
        • Grand Rapids Associated Interns
      • Kalamazoo, Michigan, Forenede Stater, 49009
        • Westside Family Medical Center
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic, Division of Endocrinology and Metabolism
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Chesterfield, Missouri, Forenede Stater, 63017
        • Diabetes and Endocrinology Specialists
      • Excelsior Springs, Missouri, Forenede Stater, 64024
        • Medical Arts Research Collaborative
      • Kansas City, Missouri, Forenede Stater, 64111
        • St Lukes Lipid and Diabetes Research Center
      • Rolla, Missouri, Forenede Stater, 65401
        • Mid Missouri Research Specialists, Inc.
      • St. Louis, Missouri, Forenede Stater, 63128
        • St. Louis Center for Clinical Research
      • St. Louis, Missouri, Forenede Stater, 63141
        • Radiant Research
      • St. Peters, Missouri, Forenede Stater, 63376
        • Midwest Pharmaceutical Research
    • Montana
      • Butte, Montana, Forenede Stater, 59701
        • Mercury Street Medical
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68131
        • Creighton Diabetes Center
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89102
        • Lovelace Scientific Resources
      • Las Vegas, Nevada, Forenede Stater, 89106
        • ICSL
    • New Hampshire
      • Dover, New Hampshire, Forenede Stater, 03820
        • Endocrinology and Diabetes Consultants, P.C.
    • New Jersey
      • Jersey City, New Jersey, Forenede Stater, 07306
        • HIS Clinical Research
      • Moorestown, New Jersey, Forenede Stater, 08057
        • Radiant Research
      • Mt. Laurel, New Jersey, Forenede Stater, 08054
        • Matrix Research Institute
      • Passaic, New Jersey, Forenede Stater, 07055
        • New Jersey Physicians
      • South Plainfield, New Jersey, Forenede Stater, 07080
        • Anderson and Collins Clinical Research, Inc.
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87108
        • Lovelace Scientific Resources
    • New York
      • Bronx, New York, Forenede Stater, 10467
        • Albert Einstein College of Medicine of Yeshiva University
      • Brooklyn, New York, Forenede Stater, 11203
        • SUNY Downstate
      • Brooklyn, New York, Forenede Stater, 11230
        • Medical Network Services, P.C.
      • Mineola, New York, Forenede Stater, 11501
        • Winthrop University Hospital
      • New York, New York, Forenede Stater, 10025
        • St. Lukes Roosevelt Hospital
      • New York, New York, Forenede Stater, 10032
        • Naomi Berrie Diabetes Center at Columbia University
      • New York, New York, Forenede Stater, 10033
        • Heights Medical Care
      • New York, New York, Forenede Stater, 10032
        • Irving Diabetes Research Unit at Columbia University
      • Rochester, New York, Forenede Stater, 14609
        • Rochester Clinical Research
      • Yonkers, New York, Forenede Stater, 10710
        • DOCS at Beth Israel Medical Center
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28209
        • Metrolina Medical Research
      • Charlotte, North Carolina, Forenede Stater, 28211
        • Charlotte Clinical Research
      • Durham, North Carolina, Forenede Stater, 27713
        • UNC Diabetes Care Center
      • Hickory, North Carolina, Forenede Stater, 28601
        • Unifour Medical Research
      • Wilmington, North Carolina, Forenede Stater, 28412
        • New Hanover Medical Research Associates
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Piedmont Medical Research
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44124
        • Rapid Medical Research
      • Columbus, Ohio, Forenede Stater, 43212
        • Radiant Research
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University-Division of Endocrinology
      • Mentor, Ohio, Forenede Stater, 44060
        • University Mednet
      • Mogadore, Ohio, Forenede Stater, 44260
        • Comprehensive Research Services, Inc.
      • Westlake, Ohio, Forenede Stater, 44145
        • North Coast Institute of Diabetes and Endocrinology
    • Oklahoma
      • Clinton, Oklahoma, Forenede Stater, 73601
        • Prime Care Clinical Research
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • OU Health Sciences Center
      • Oklahoma City, Oklahoma, Forenede Stater, 73103
        • COR Clinical Research
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • nTouch Research Corporation
      • Tulsa, Oklahoma, Forenede Stater, 74104
        • Utica Park Clinic
    • Oregon
      • Medford, Oregon, Forenede Stater, 97504
        • Medford Medical Clinic
      • Medford, Oregon, Forenede Stater, 97504
        • Americas Doctors
      • Portland, Oregon, Forenede Stater, 97232
        • Legacy Clinical Research
      • Portland, Oregon, Forenede Stater, 97201
        • Radiant Research
      • Portland, Oregon, Forenede Stater, 97210
        • Portland Diabetes and Endocrinology Center
      • Portland, Oregon, Forenede Stater, 97214
        • Pacific Coast Clinical Coordinators, Inc.
    • Pennsylvania
      • Camp Hill, Pennsylvania, Forenede Stater, 17011
        • Physicians for Clinical Research
      • Horsham, Pennsylvania, Forenede Stater, 19044-12297
        • Argus Research Laboratories
      • Philadelphia, Pennsylvania, Forenede Stater, 19141
        • Albert Einstein Medical Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University Diabetes Research Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19146
        • Philadelphia Health Associates
      • Sellersville, Pennsylvania, Forenede Stater, 18960
        • Elite Medical Research, Inc.
      • Tipton, Pennsylvania, Forenede Stater, 16684
        • Tipton Medical and Diagnostic Center
    • Rhode Island
      • East Providence, Rhode Island, Forenede Stater, 02914
        • Safe Harbor Clinical Research
      • East Providence, Rhode Island, Forenede Stater, 02915
        • ICSL-Providence
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29407
        • Radiant Research
      • Chester, South Carolina, Forenede Stater, 29706
        • CNS Clinical Trials
      • Mt. Pleasant, South Carolina, Forenede Stater, 29464
        • Coastal Carolina Research Center
    • Tennessee
      • Alcoa, Tennessee, Forenede Stater, 37701
        • Tennessee Valley Clinical Research Associates
      • Jackson, Tennessee, Forenede Stater, 38305
        • Integrity Clinical Research
      • Johnson City, Tennessee, Forenede Stater, 37601
        • Harmony Clinical Research
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Holston Medical Group
      • Knoxville, Tennessee, Forenede Stater, 37909
        • Endocrine Consultants of ET
      • Memphis, Tennessee, Forenede Stater, 38119
        • The Endocrine Clinic
      • Milan, Tennessee, Forenede Stater, 38358
        • Integrity Clinical Research
      • Nashville, Tennessee, Forenede Stater, 37203
        • Mid State Endocrine Associates
    • Texas
      • Arlington, Texas, Forenede Stater, 76014
        • Israel A. Hartman, M.D.
      • Austin, Texas, Forenede Stater, 78705
        • Central Texas Clinical Research
      • Dallas, Texas, Forenede Stater, 75251
        • Rafael Canadas M.D., P.A.
      • Dallas, Texas, Forenede Stater, 75230
        • Dallas Diabetes and Endocrinology Research Center
      • El Paso, Texas, Forenede Stater, 79905
        • Texas Tech University Health Sciences-Internal Medicine
      • El Paso, Texas, Forenede Stater, 79912
        • Internal Medicine Associates
      • Fort Worth, Texas, Forenede Stater, 76107
        • Lanier Education Research Network
      • Irving, Texas, Forenede Stater, 75038
        • North Texas Clinical Research
      • Kingsville, Texas, Forenede Stater, 78363
        • Dr. Humberto Bruschetta
      • Lake Jackson, Texas, Forenede Stater, 77566
        • R/D Clinical Research, Inc.
      • McAllen, Texas, Forenede Stater, 78503
        • South Texas Applied Research
      • San Antonio, Texas, Forenede Stater, 78207
        • University of Texas Health Sciences Center-Texas Diabetes Institute
      • San Antonio, Texas, Forenede Stater, 78229-3894
        • Diabetes and Glandular Disease Clinic
      • San Antonio, Texas, Forenede Stater, 78205
        • Sun Research Institute
      • San Antonio, Texas, Forenede Stater, 78229
        • SAM Clinical Research
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84124
        • Salt Lake Research
      • Salt Lake City, Utah, Forenede Stater, 84108
        • Utah Diabetes Center at the University of Utah
    • Virginia
      • Arlington, Virginia, Forenede Stater, 22204
        • Medical Associates of Northern Virginia
      • Norfolk, Virginia, Forenede Stater, 23507
        • Clinical Research Center-Eastern Virginia Medical School
      • Richmond, Virginia, Forenede Stater, 23225
        • Drs. Wigand, Wasserman, and Associates
    • Washington
      • Kirkland, Washington, Forenede Stater, 98034
        • Evergreen Diabetes & Endocrinology
      • Lacey, Washington, Forenede Stater, 98516
        • Olympic Medical Services
      • Olympia, Washington, Forenede Stater, 98502
        • West Olympia Internal Medicine
      • Renton, Washington, Forenede Stater, 98055
        • Rainier Clinical Research Center
      • Spokane, Washington, Forenede Stater, 99202
        • Rockwood Clinic
      • Spokane, Washington, Forenede Stater, 99201
        • Northside Internal Medicine
      • Spokane, Washington, Forenede Stater, 99204
        • Julia M. Hutchinson, M.D.
      • Wenatchee, Washington, Forenede Stater, 98801
        • Wenatchee Valley Clinic
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25304
        • CAMC Clinical Trials Center
      • Charleston, West Virginia, Forenede Stater, 25301
        • Hyperion Clinical Research
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53711
        • University of Wisconsin West Clinic
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Midwest Endocrinology Associates
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • VRG Research

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år til 75 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Open-label AC2993
Medicin: 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
Andre navne:
  • Exenatid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in HbA1c from Day 1 of Protocol 2993-112 to Week 52 (or termination)
Tidsramme: 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)
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2002

Primær færdiggørelse (Faktiske)

1. juni 2004

Studieafslutning (Faktiske)

1. juni 2004

Datoer for studieregistrering

Først indsendt

11. februar 2013

Først indsendt, der opfyldte QC-kriterier

11. februar 2013

Først opslået (Skøn)

12. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. februar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. februar 2015

Sidst verificeret

1. januar 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2993-112E

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