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Extension Study for 2993-112

23. februar 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

225

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

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

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Andre navn:
  • Exenatid

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2002

Primær fullføring (Faktiske)

1. juni 2004

Studiet fullført (Faktiske)

1. juni 2004

Datoer for studieregistrering

Først innsendt

11. februar 2013

Først innsendt som oppfylte QC-kriteriene

11. februar 2013

Først lagt ut (Anslag)

12. februar 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. februar 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. februar 2015

Sist bekreftet

1. januar 2015

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere