Extension Study for 2993-112

NCT ID: NCT01789957

Last Updated: 2015-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2004-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open-label AC2993

Group Type EXPERIMENTAL

AC2993

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Exenatide

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pinnacle Research Group

Anniston, Alabama, United States

Site Status

Parkway Medical Center

Birmingham, Alabama, United States

Site Status

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Site Status

Eclectic Family Care

Eclectic, Alabama, United States

Site Status

Winston Physician Services

Haleyville, Alabama, United States

Site Status

Simon Williamson Clinic

Hueytown, Alabama, United States

Site Status

Extended Arm Physicians/ Southern Drug

Montgomery, Alabama, United States

Site Status

Southern Drug Research Network

Tallassee, Alabama, United States

Site Status

Mesa Center for Clinical Research

Chandler, Arizona, United States

Site Status

Clinic of Physicians and Surgeons, Ltd.

Mesa, Arizona, United States

Site Status

ANA Ventures, LLC

Mesa, Arizona, United States

Site Status

Lovelace Scientific Resources

Phoenix, Arizona, United States

Site Status

Physicians at the Peak

Phoenix, Arizona, United States

Site Status

Advanced Clinical Therapeutics

Tucson, Arizona, United States

Site Status

First Care Family Doctors

Fayetteville, Arkansas, United States

Site Status

CAVHS

Little Rock, Arkansas, United States

Site Status

Physicians Group Research Clinic, LLC

Little Rock, Arkansas, United States

Site Status

Advanced Clinical Research Institute

Anaheim, California, United States

Site Status

Endocrine Metabolic Medical Center

Atherton, California, United States

Site Status

Mitchell Research Group, Inc.

Bakersfield, California, United States

Site Status

William Zigrang, M.D.

Burlingame, California, United States

Site Status

International Clinical Research Network

Chula Vista, California, United States

Site Status

Arrowhead Regional Medical Center

Colton, California, United States

Site Status

East Bay Clinical Trial Center

Concord, California, United States

Site Status

Medical Group of Encino

Encino, California, United States

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Mowry Clinical Research

Fremont, California, United States

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SARC Research Center

Fresno, California, United States

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Valley Research

Fresno, California, United States

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Irvine Clinical Research Center

Irvine, California, United States

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Whittier Institute for Diabetes

La Jolla, California, United States

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Harriman Jones Medical Group

Long Beach, California, United States

Site Status

Richard Cherlin, M.D.

Los Gatos, California, United States

Site Status

Tushar Modi, M.D.

Modesto, California, United States

Site Status

Dr. Martinez Medical Clinic

Moreno Valley, California, United States

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Arroyo Seco Medical Group

Pasadena, California, United States

Site Status

Elke Jost-Vu, M.D.

Rancho Mirage, California, United States

Site Status

Comprehensive Diabetes-Endocrine Medical Associates

Redwood City, California, United States

Site Status

nTouch

San Diego, California, United States

Site Status

Radiant Research

San Diego, California, United States

Site Status

San Diego Endocrine and Medical Clinic

San Diego, California, United States

Site Status

Veterans Medical Research Foundation

San Diego, California, United States

Site Status

Diabetes Research Institute of Mills Peninsula

San Mateo, California, United States

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Advanced Clinical Research Institute

Santa Ana, California, United States

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Pacific Clinical Research

Santa Monica, California, United States

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West Coast Clinical Trials

Signal Hill, California, United States

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Protocare Trials at Sharp Mission Park

Vista, California, United States

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Diablo Clinical Research

Walnut Creek, California, United States

Site Status

University of Colorado-Barbara Davis Center for Childhood Diabetes

Denver, Colorado, United States

Site Status

Pheonix International Medicine Associates

Waterbury, Connecticut, United States

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Health Core at Health Care Center Christiana

Newark, Delaware, United States

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Medstar Clinical Research

Washington D.C., District of Columbia, United States

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George Washington University

Washington D.C., District of Columbia, United States

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Morton Plant Mease Health Care

Clearwater, Florida, United States

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Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

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Atlantic Institute of Clinical Research

Daytona Beach, Florida, United States

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Halifax Clinical Research Institute

Daytona Beach, Florida, United States

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Internal Medical Associates

Fort Myers, Florida, United States

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Clin Sci International

Gainesville, Florida, United States

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University of FL

Gainesville, Florida, United States

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South Florida Clinical Research Center

Hollywood, Florida, United States

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Health Trials 3000

Jacksonville, Florida, United States

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Jupiter Research Institute

Jupiter, Florida, United States

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ICSL Clinical Studies

Maitland, Florida, United States

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Baptist Diabetes Associates

Miami, Florida, United States

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Suncoast Clinical Research

New Port Richey, Florida, United States

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VRG Research

Orlando, Florida, United States

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Highland Lakes Medical Center

Palm Harbor, Florida, United States

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Tallahassee Endocrine Associates

Tallahassee, Florida, United States

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Biostator / USF Diabetes Center

Tampa, Florida, United States

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Tampa Medical Group

Tampa, Florida, United States

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Diabetes and Endocrine Associates of the Treasure Co

Vero Beach, Florida, United States

Site Status

Metabolic Research Institute, Inc.

West Palm Beach, Florida, United States

Site Status

Radiant Research

West Palm Beach, Florida, United States

Site Status

ICSL-Clinical Studies

Atlanta, Georgia, United States

Site Status

Clinical Research Atlanta

Atlanta, Georgia, United States

Site Status

Columbus Metabolic Foundation

Columbus, Georgia, United States

Site Status

nTouch Research Corporation

Decatur, Georgia, United States

Site Status

East-West Medical Research Institute

Honolulu, Hawaii, United States

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Radiant Research

Honolulu, Hawaii, United States

Site Status

St. Luke's Family Health

Meridian, Idaho, United States

Site Status

University Primary Care Center at Belvidere

Belvidere, Illinois, United States

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Northwestern Memorail Physicians Group

Chicago, Illinois, United States

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Illinois Center for Clinical Trials

Chicago, Illinois, United States

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Cook County Hospital

Chicago, Illinois, United States

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Lake Forest Internal Medicine

Libertyville, Illinois, United States

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Winchester Research Group

Libertyville, Illinois, United States

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Springfield Clinic

Springfield, Illinois, United States

Site Status

Springfield Diabetes and Endocrinology

Springfield, Illinois, United States

Site Status

Medical Group of Fort Wayne

Fort Wayne, Indiana, United States

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Indiana University Outpatient Clinical Research

Indianapolis, Indiana, United States

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American Health Network

Indianapolis, Indiana, United States

Site Status

Center for Metabolic and Hormonal Disorders

Indianapolis, Indiana, United States

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nTouch Research Corporation

South Bend, Indiana, United States

Site Status

Ramona Holiday Diabetes Center

Des Moines, Iowa, United States

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Diabetes Clinical Research and Programs

Iowa City, Iowa, United States

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Lipid, Atherosclerosis & Metabolic Clinic

Kansas City, Kansas, United States

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Kentucky Diabetes Center

Lexington, Kentucky, United States

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Central Kentucky Research Associates

Lexington, Kentucky, United States

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University of Kentucky Metabolic Research Group

Lexington, Kentucky, United States

Site Status

MedResearch, Inc.

Louisville, Kentucky, United States

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Drug Research Services

Metairie, Louisiana, United States

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New Orleans Institute of Clinical Investigation

New Orleans, Louisiana, United States

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New Orleans Center for Clinical Research

New Orleans, Louisiana, United States

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Ochsner Clinic

New Orleans, Louisiana, United States

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Diabetes, Endocrine and Nutrition Center

Bangor, Maine, United States

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VA Medical Center

Baltimore, Maryland, United States

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St. Agnes Health Care

Baltimore, Maryland, United States

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Doctors Research Associates of Maryland

Lanham, Maryland, United States

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University of Michigan-Endocrinology and Metabolism

Ann Arbor, Michigan, United States

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Grunberger Diabetes Medical Center

Bloomfield Hills, Michigan, United States

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Henry Ford Health System

Detroit, Michigan, United States

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Grand Rapids Associated Interns

Grand Rapids, Michigan, United States

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Westside Family Medical Center

Kalamazoo, Michigan, United States

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Mayo Clinic, Division of Endocrinology and Metabolism

Rochester, Minnesota, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

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Diabetes and Endocrinology Specialists

Chesterfield, Missouri, United States

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Midwest Pharmaceutical Research

City of Saint Peters, Missouri, United States

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Medical Arts Research Collaborative

Excelsior Springs, Missouri, United States

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St Lukes Lipid and Diabetes Research Center

Kansas City, Missouri, United States

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Mid Missouri Research Specialists, Inc.

Rolla, Missouri, United States

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St. Louis Center for Clinical Research

St Louis, Missouri, United States

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Radiant Research

St Louis, Missouri, United States

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Mercury Street Medical

Butte, Montana, United States

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Creighton Diabetes Center

Omaha, Nebraska, United States

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Lovelace Scientific Resources

Las Vegas, Nevada, United States

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ICSL

Las Vegas, Nevada, United States

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Endocrinology and Diabetes Consultants, P.C.

Dover, New Hampshire, United States

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HIS Clinical Research

Jersey City, New Jersey, United States

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Radiant Research

Moorestown, New Jersey, United States

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Matrix Research Institute

Mount Laurel, New Jersey, United States

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New Jersey Physicians

Passaic, New Jersey, United States

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Anderson and Collins Clinical Research, Inc.

South Plainfield, New Jersey, United States

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Lovelace Scientific Resources

Albuquerque, New Mexico, United States

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SUNY Downstate

Brooklyn, New York, United States

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Medical Network Services, P.C.

Brooklyn, New York, United States

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Winthrop University Hospital

Mineola, New York, United States

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St. Lukes Roosevelt Hospital

New York, New York, United States

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Irving Diabetes Research Unit at Columbia University

New York, New York, United States

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Naomi Berrie Diabetes Center at Columbia University

New York, New York, United States

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Heights Medical Care

New York, New York, United States

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Rochester Clinical Research

Rochester, New York, United States

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Albert Einstein College of Medicine of Yeshiva University

The Bronx, New York, United States

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DOCS at Beth Israel Medical Center

Yonkers, New York, United States

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Metrolina Medical Research

Charlotte, North Carolina, United States

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Charlotte Clinical Research

Charlotte, North Carolina, United States

Site Status

UNC Diabetes Care Center

Durham, North Carolina, United States

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Unifour Medical Research

Hickory, North Carolina, United States

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New Hanover Medical Research Associates

Wilmington, North Carolina, United States

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Piedmont Medical Research

Winston-Salem, North Carolina, United States

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Rapid Medical Research

Cleveland, Ohio, United States

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Ohio State University-Division of Endocrinology

Columbus, Ohio, United States

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Radiant Research

Columbus, Ohio, United States

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University Mednet

Mentor, Ohio, United States

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Comprehensive Research Services, Inc.

Mogadore, Ohio, United States

Site Status

North Coast Institute of Diabetes and Endocrinology

Westlake, Ohio, United States

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Prime Care Clinical Research

Clinton, Oklahoma, United States

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COR Clinical Research

Oklahoma City, Oklahoma, United States

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OU Health Sciences Center

Oklahoma City, Oklahoma, United States

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nTouch Research Corporation

Oklahoma City, Oklahoma, United States

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Utica Park Clinic

Tulsa, Oklahoma, United States

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Americas Doctors

Medford, Oregon, United States

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Medford Medical Clinic

Medford, Oregon, United States

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Radiant Research

Portland, Oregon, United States

Site Status

Portland Diabetes and Endocrinology Center

Portland, Oregon, United States

Site Status

Pacific Coast Clinical Coordinators, Inc.

Portland, Oregon, United States

Site Status

Legacy Clinical Research

Portland, Oregon, United States

Site Status

Physicians for Clinical Research

Camp Hill, Pennsylvania, United States

Site Status

Argus Research Laboratories

Horsham, Pennsylvania, United States

Site Status

Thomas Jefferson University Diabetes Research Center

Philadelphia, Pennsylvania, United States

Site Status

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

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Philadelphia Health Associates

Philadelphia, Pennsylvania, United States

Site Status

Elite Medical Research, Inc.

Sellersville, Pennsylvania, United States

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Tipton Medical and Diagnostic Center

Tipton, Pennsylvania, United States

Site Status

Safe Harbor Clinical Research

East Providence, Rhode Island, United States

Site Status

ICSL-Providence

East Providence, Rhode Island, United States

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Radiant Research

Charleston, South Carolina, United States

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CNS Clinical Trials

Chester, South Carolina, United States

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Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

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Tennessee Valley Clinical Research Associates

Alcoa, Tennessee, United States

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Integrity Clinical Research

Jackson, Tennessee, United States

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Harmony Clinical Research

Johnson City, Tennessee, United States

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Holston Medical Group

Kingsport, Tennessee, United States

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Endocrine Consultants of ET

Knoxville, Tennessee, United States

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The Endocrine Clinic

Memphis, Tennessee, United States

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Integrity Clinical Research

Milan, Tennessee, United States

Site Status

Mid State Endocrine Associates

Nashville, Tennessee, United States

Site Status

Israel A. Hartman, M.D.

Arlington, Texas, United States

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Central Texas Clinical Research

Austin, Texas, United States

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Dallas Diabetes and Endocrinology Research Center

Dallas, Texas, United States

Site Status

Rafael Canadas M.D., P.A.

Dallas, Texas, United States

Site Status

Texas Tech University Health Sciences-Internal Medicine

El Paso, Texas, United States

Site Status

Internal Medicine Associates

El Paso, Texas, United States

Site Status

Lanier Education Research Network

Fort Worth, Texas, United States

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North Texas Clinical Research

Irving, Texas, United States

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Dr. Humberto Bruschetta

Kingsville, Texas, United States

Site Status

R/D Clinical Research, Inc.

Lake Jackson, Texas, United States

Site Status

South Texas Applied Research

McAllen, Texas, United States

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Sun Research Institute

San Antonio, Texas, United States

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University of Texas Health Sciences Center-Texas Diabetes Institute

San Antonio, Texas, United States

Site Status

Diabetes and Glandular Disease Clinic

San Antonio, Texas, United States

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SAM Clinical Research

San Antonio, Texas, United States

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Utah Diabetes Center at the University of Utah

Salt Lake City, Utah, United States

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Salt Lake Research

Salt Lake City, Utah, United States

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Medical Associates of Northern Virginia

Arlington, Virginia, United States

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Clinical Research Center-Eastern Virginia Medical School

Norfolk, Virginia, United States

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Drs. Wigand, Wasserman, and Associates

Richmond, Virginia, United States

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Evergreen Diabetes & Endocrinology

Kirkland, Washington, United States

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Olympic Medical Services

Lacey, Washington, United States

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West Olympia Internal Medicine

Olympia, Washington, United States

Site Status

Rainier Clinical Research Center

Renton, Washington, United States

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Northside Internal Medicine

Spokane, Washington, United States

Site Status

Rockwood Clinic

Spokane, Washington, United States

Site Status

Julia M. Hutchinson, M.D.

Spokane, Washington, United States

Site Status

Wenatchee Valley Clinic

Wenatchee, Washington, United States

Site Status

Hyperion Clinical Research

Charleston, West Virginia, United States

Site Status

CAMC Clinical Trials Center

Charleston, West Virginia, United States

Site Status

University of Wisconsin West Clinic

Madison, Wisconsin, United States

Site Status

Midwest Endocrinology Associates

Milwaukee, Wisconsin, United States

Site Status

VRG Research

Milwaukee, Wisconsin, United States

Site Status

Calgary Metabolic Education and Research Center

Calgary, Alberta, Canada

Site Status

Walter McKenzie Health Sciences Centre

Edmonton, Alberta, Canada

Site Status

St. Paul's Hospital, Research Services

Vancouver, British Columbia, Canada

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Health Sciences Center

Winnipeg, Manitoba, Canada

Site Status

University of Western Ontario

London, Ontario, Canada

Site Status

McGill Nutrition and Food Science Center

Montreal, Quebec, Canada

Site Status

Centre Hospitalier

Ste. Foy, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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2993-112E

Identifier Type: -

Identifier Source: org_study_id

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