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Type 2 Diabetes MellitusPhase 3NCT01789957

Extension Study for 2993-112

A Phase 3 study testing AC2993 in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 226 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
AC2993
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
226 sitesin 2 countries
Study dates
Sep 2002to Jun 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Trial locations and contacts

226 sites in 2 countries.

226 sites in 2 countries

United States219 sites

  • Lovelace Scientific Resources

    Albuquerque, New Mexico, 87108

  • Tennessee Valley Clinical Research Associates

    Alcoa, Tennessee, 37701

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • University of Michigan-Endocrinology and Metabolism

    Ann Arbor, Michigan, 48109

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • Israel A. Hartman, M.D.

    Arlington, Texas, 76014

  • Medical Associates of Northern Virginia

    Arlington, Virginia, 22204

  • Endocrine Metabolic Medical Center

    Atherton, California, 94027

  • ICSL-Clinical Studies

    Atlanta, Georgia, 30328

  • Clinical Research Atlanta

    Atlanta, Georgia, 30342

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Mitchell Research Group, Inc.

    Bakersfield, California, 93309

  • VA Medical Center

    Baltimore, Maryland, 21201

  • St. Agnes Health Care

    Baltimore, Maryland, 21229

  • Diabetes, Endocrine and Nutrition Center

    Bangor, Maine, 04401

  • University Primary Care Center at Belvidere

    Belvidere, Illinois, 61008

  • Parkway Medical Center

    Birmingham, Alabama, 35206

  • Alabama Clinical Therapeutics

    Birmingham, Alabama, 35235

  • Grunberger Diabetes Medical Center

    Bloomfield Hills, Michigan, 48302

  • SUNY Downstate

    Brooklyn, New York, 11203

  • Medical Network Services, P.C.

    Brooklyn, New York, 11230

  • William Zigrang, M.D.

    Burlingame, California, 94010

  • Mercury Street Medical

    Butte, Montana, 59701

  • Physicians for Clinical Research

    Camp Hill, Pennsylvania, 17011

  • Mesa Center for Clinical Research

    Chandler, Arizona, 85224

  • Radiant Research

    Charleston, South Carolina, 29407

  • Hyperion Clinical Research

    Charleston, West Virginia, 25301

  • CAMC Clinical Trials Center

    Charleston, West Virginia, 25304

  • Metrolina Medical Research

    Charlotte, North Carolina, 28209

  • Charlotte Clinical Research

    Charlotte, North Carolina, 28211

  • CNS Clinical Trials

    Chester, South Carolina, 29706

  • Diabetes and Endocrinology Specialists

    Chesterfield, Missouri, 63017

  • Northwestern Memorail Physicians Group

    Chicago, Illinois, 60602

  • Illinois Center for Clinical Trials

    Chicago, Illinois, 60610

  • Cook County Hospital

    Chicago, Illinois, 60612

  • International Clinical Research Network

    Chula Vista, California, 91910

  • Midwest Pharmaceutical Research

    City of Saint Peters, Missouri, 63376

  • Morton Plant Mease Health Care

    Clearwater, Florida, 33756

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • Rapid Medical Research

    Cleveland, Ohio, 44124

  • Prime Care Clinical Research

    Clinton, Oklahoma, 73601

  • Arrowhead Regional Medical Center

    Colton, California, 92324

  • Columbus Metabolic Foundation

    Columbus, Georgia, 31901

  • Ohio State University-Division of Endocrinology

    Columbus, Ohio, 43210

  • Radiant Research

    Columbus, Ohio, 43212

  • East Bay Clinical Trial Center

    Concord, California, 94520

  • Dallas Diabetes and Endocrinology Research Center

    Dallas, Texas, 75230

  • Rafael Canadas M.D., P.A.

    Dallas, Texas, 75251

  • Atlantic Institute of Clinical Research

    Daytona Beach, Florida, 32114

  • Halifax Clinical Research Institute

    Daytona Beach, Florida, 32114

  • nTouch Research Corporation

    Decatur, Georgia, 30033

  • University of Colorado-Barbara Davis Center for Childhood Diabetes

    Denver, Colorado, 80262

  • Ramona Holiday Diabetes Center

    Des Moines, Iowa, 50314

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Endocrinology and Diabetes Consultants, P.C.

    Dover, New Hampshire, 03820

  • UNC Diabetes Care Center

    Durham, North Carolina, 27713

  • Safe Harbor Clinical Research

    East Providence, Rhode Island, 02914

  • ICSL-Providence

    East Providence, Rhode Island, 02915

  • Eclectic Family Care

    Eclectic, Alabama, 36024

  • Texas Tech University Health Sciences-Internal Medicine

    El Paso, Texas, 79905

  • Internal Medicine Associates

    El Paso, Texas, 79912

  • Medical Group of Encino

    Encino, California, 91436

  • Medical Arts Research Collaborative

    Excelsior Springs, Missouri, 64024

  • First Care Family Doctors

    Fayetteville, Arkansas, 72701

  • Internal Medical Associates

    Fort Myers, Florida, 33901

  • Medical Group of Fort Wayne

    Fort Wayne, Indiana, 46804

  • Lanier Education Research Network

    Fort Worth, Texas, 76107

  • Mowry Clinical Research

    Fremont, California, 94538

  • SARC Research Center

    Fresno, California, 93720-2955

  • Valley Research

    Fresno, California, 93720

  • Clin Sci International

    Gainesville, Florida, 32605

  • University of FL

    Gainesville, Florida, 32610-0226

  • Grand Rapids Associated Interns

    Grand Rapids, Michigan, 49506

  • Winston Physician Services

    Haleyville, Alabama, 35565

  • Unifour Medical Research

    Hickory, North Carolina, 28601

  • South Florida Clinical Research Center

    Hollywood, Florida, 33023

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96813

  • Radiant Research

    Honolulu, Hawaii, 96814

  • Argus Research Laboratories

    Horsham, Pennsylvania, 19044-12297

  • Simon Williamson Clinic

    Hueytown, Alabama, 35023

  • Indiana University Outpatient Clinical Research

    Indianapolis, Indiana, 46202

  • American Health Network

    Indianapolis, Indiana, 46222

  • Center for Metabolic and Hormonal Disorders

    Indianapolis, Indiana, 46260

  • Diabetes Clinical Research and Programs

    Iowa City, Iowa, 52242-1009

  • Irvine Clinical Research Center

    Irvine, California, 92618

  • North Texas Clinical Research

    Irving, Texas, 75038

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Integrity Clinical Research

    Jackson, Tennessee, 38305

  • Health Trials 3000

    Jacksonville, Florida, 32250

  • HIS Clinical Research

    Jersey City, New Jersey, 07306

  • Harmony Clinical Research

    Johnson City, Tennessee, 37601

  • Jupiter Research Institute

    Jupiter, Florida, 33458

  • Westside Family Medical Center

    Kalamazoo, Michigan, 49009

  • Lipid, Atherosclerosis & Metabolic Clinic

    Kansas City, Kansas, 66160

  • St Lukes Lipid and Diabetes Research Center

    Kansas City, Missouri, 64111

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Dr. Humberto Bruschetta

    Kingsville, Texas, 78363

  • Evergreen Diabetes & Endocrinology

    Kirkland, Washington, 98034

  • Endocrine Consultants of ET

    Knoxville, Tennessee, 37909

  • Whittier Institute for Diabetes

    La Jolla, California, 92037

  • Olympic Medical Services

    Lacey, Washington, 98516

  • R/D Clinical Research, Inc.

    Lake Jackson, Texas, 77566

  • Doctors Research Associates of Maryland

    Lanham, Maryland, 20706

  • Lovelace Scientific Resources

    Las Vegas, Nevada, 89102

  • ICSL

    Las Vegas, Nevada, 89106

  • Kentucky Diabetes Center

    Lexington, Kentucky, 40503

  • Central Kentucky Research Associates

    Lexington, Kentucky, 40509

  • University of Kentucky Metabolic Research Group

    Lexington, Kentucky, 40536-9841

  • Lake Forest Internal Medicine

    Libertyville, Illinois, 60048

  • Winchester Research Group

    Libertyville, Illinois, 60048

  • CAVHS

    Little Rock, Arkansas, 72205

  • Physicians Group Research Clinic, LLC

    Little Rock, Arkansas, 72205

  • Harriman Jones Medical Group

    Long Beach, California, 90806

  • Richard Cherlin, M.D.

    Los Gatos, California, 95032

  • MedResearch, Inc.

    Louisville, Kentucky, 40223

  • University of Wisconsin West Clinic

    Madison, Wisconsin, 53711

  • ICSL Clinical Studies

    Maitland, Florida, 32751

  • South Texas Applied Research

    McAllen, Texas, 78503

  • Americas Doctors

    Medford, Oregon, 97504

  • Medford Medical Clinic

    Medford, Oregon, 97504

  • The Endocrine Clinic

    Memphis, Tennessee, 38119

  • University Mednet

    Mentor, Ohio, 44060

  • St. Luke's Family Health

    Meridian, Idaho, 83642

  • Clinic of Physicians and Surgeons, Ltd.

    Mesa, Arizona, 85201

  • ANA Ventures, LLC

    Mesa, Arizona, 85204

  • Drug Research Services

    Metairie, Louisiana, 70001

  • Baptist Diabetes Associates

    Miami, Florida, 33176

  • Integrity Clinical Research

    Milan, Tennessee, 38358

  • Midwest Endocrinology Associates

    Milwaukee, Wisconsin, 53215

  • VRG Research

    Milwaukee, Wisconsin, 53226

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Tushar Modi, M.D.

    Modesto, California, 95350

  • Comprehensive Research Services, Inc.

    Mogadore, Ohio, 44260

  • Extended Arm Physicians/ Southern Drug

    Montgomery, Alabama, 36106

  • Radiant Research

    Moorestown, New Jersey, 08057

  • Dr. Martinez Medical Clinic

    Moreno Valley, California, 92553

  • Matrix Research Institute

    Mount Laurel, New Jersey, 08054

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Mid State Endocrine Associates

    Nashville, Tennessee, 37203

  • New Orleans Institute of Clinical Investigation

    New Orleans, Louisiana, 70112

  • New Orleans Center for Clinical Research

    New Orleans, Louisiana, 70119

  • Ochsner Clinic

    New Orleans, Louisiana, 70121

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • St. Lukes Roosevelt Hospital

    New York, New York, 10025

  • Irving Diabetes Research Unit at Columbia University

    New York, New York, 10032

  • Naomi Berrie Diabetes Center at Columbia University

    New York, New York, 10032

  • Heights Medical Care

    New York, New York, 10033

  • Health Core at Health Care Center Christiana

    Newark, Delaware, 19713

  • Clinical Research Center-Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • COR Clinical Research

    Oklahoma City, Oklahoma, 73103

  • OU Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • nTouch Research Corporation

    Oklahoma City, Oklahoma, 73112

  • West Olympia Internal Medicine

    Olympia, Washington, 98502

  • Creighton Diabetes Center

    Omaha, Nebraska, 68131

  • VRG Research

    Orlando, Florida, 32801

  • Highland Lakes Medical Center

    Palm Harbor, Florida, 34684

  • Arroyo Seco Medical Group

    Pasadena, California, 91105

  • New Jersey Physicians

    Passaic, New Jersey, 07055

  • Thomas Jefferson University Diabetes Research Center

    Philadelphia, Pennsylvania, 19107

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Philadelphia Health Associates

    Philadelphia, Pennsylvania, 19146

  • Lovelace Scientific Resources

    Phoenix, Arizona, 85016

  • Physicians at the Peak

    Phoenix, Arizona, 85020

  • Radiant Research

    Portland, Oregon, 97201

  • Portland Diabetes and Endocrinology Center

    Portland, Oregon, 97210

  • Pacific Coast Clinical Coordinators, Inc.

    Portland, Oregon, 97214

  • Legacy Clinical Research

    Portland, Oregon, 97232

  • Elke Jost-Vu, M.D.

    Rancho Mirage, California, 92270

  • Comprehensive Diabetes-Endocrine Medical Associates

    Redwood City, California, 94062

  • Rainier Clinical Research Center

    Renton, Washington, 98055

  • Drs. Wigand, Wasserman, and Associates

    Richmond, Virginia, 23225

  • Mayo Clinic, Division of Endocrinology and Metabolism

    Rochester, Minnesota, 55905

  • Rochester Clinical Research

    Rochester, New York, 14609

  • Mid Missouri Research Specialists, Inc.

    Rolla, Missouri, 65401

  • Utah Diabetes Center at the University of Utah

    Salt Lake City, Utah, 84108

  • Salt Lake Research

    Salt Lake City, Utah, 84124

  • Sun Research Institute

    San Antonio, Texas, 78205

  • University of Texas Health Sciences Center-Texas Diabetes Institute

    San Antonio, Texas, 78207

  • Diabetes and Glandular Disease Clinic

    San Antonio, Texas, 78229-3894

  • SAM Clinical Research

    San Antonio, Texas, 78229

  • nTouch

    San Diego, California, 92103

  • Radiant Research

    San Diego, California, 92108

  • San Diego Endocrine and Medical Clinic

    San Diego, California, 92108

  • Veterans Medical Research Foundation

    San Diego, California, 92161

  • Diabetes Research Institute of Mills Peninsula

    San Mateo, California, 94401

  • Advanced Clinical Research Institute

    Santa Ana, California, 92701

  • Pacific Clinical Research

    Santa Monica, California, 90404

  • Elite Medical Research, Inc.

    Sellersville, Pennsylvania, 18960

  • West Coast Clinical Trials

    Signal Hill, California, 90755

  • nTouch Research Corporation

    South Bend, Indiana, 46601

  • Anderson and Collins Clinical Research, Inc.

    South Plainfield, New Jersey, 07080

  • Northside Internal Medicine

    Spokane, Washington, 99201

  • Rockwood Clinic

    Spokane, Washington, 99202

  • Julia M. Hutchinson, M.D.

    Spokane, Washington, 99204

  • Springfield Clinic

    Springfield, Illinois, 62703

  • Springfield Diabetes and Endocrinology

    Springfield, Illinois, 62704

  • St. Louis Center for Clinical Research

    St Louis, Missouri, 63128

  • Radiant Research

    St Louis, Missouri, 63141

  • Tallahassee Endocrine Associates

    Tallahassee, Florida, 32308

  • Southern Drug Research Network

    Tallassee, Alabama, 36078

  • Biostator / USF Diabetes Center

    Tampa, Florida, 33612

  • Tampa Medical Group

    Tampa, Florida, 33614

  • Albert Einstein College of Medicine of Yeshiva University

    The Bronx, New York, 10467

  • Tipton Medical and Diagnostic Center

    Tipton, Pennsylvania, 16684

  • Advanced Clinical Therapeutics

    Tucson, Arizona, 85712

  • Utica Park Clinic

    Tulsa, Oklahoma, 74104

  • Diabetes and Endocrine Associates of the Treasure Co

    Vero Beach, Florida, 32967

  • Protocare Trials at Sharp Mission Park

    Vista, California, 92083

  • Diablo Clinical Research

    Walnut Creek, California, 94598

  • Medstar Clinical Research

    Washington D.C., District of Columbia, 20003-4393

  • George Washington University

    Washington D.C., District of Columbia, 20037

  • Pheonix International Medicine Associates

    Waterbury, Connecticut, 06708

  • Wenatchee Valley Clinic

    Wenatchee, Washington, 98801

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

  • Radiant Research

    West Palm Beach, Florida, 33407

  • North Coast Institute of Diabetes and Endocrinology

    Westlake, Ohio, 44145

  • New Hanover Medical Research Associates

    Wilmington, North Carolina, 28412

  • Piedmont Medical Research

    Winston-Salem, North Carolina, 27103

  • DOCS at Beth Israel Medical Center

    Yonkers, New York, 10710

Other trials in United States

Canada7 sites

  • Calgary Metabolic Education and Research Center

    Calgary, Alberta, T3B 0M3

  • Walter McKenzie Health Sciences Centre

    Edmonton, Alberta, T6G 2B7

  • University of Western Ontario

    London, Ontario, N6A 4V2

  • McGill Nutrition and Food Science Center

    Montreal, Quebec, H3A 1A1

  • Centre Hospitalier

    Ste. Foy, Quebec, G1V 4G2

  • St. Paul's Hospital, Research Services

    Vancouver, British Columbia, V6Z 1Y6

  • Health Sciences Center

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

About this study

Official title: 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.

Being tested
AC2993
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AC2993Drug

    Also called Exenatide

    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

Study groups in NCT01789957
Study groupRoleWhat they receive
Open-label AC2993ExperimentalNot described
Receives: Drug: AC2993

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c from Day 1 of Protocol 2993-112 to Week 52 (or termination)

    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.

    Measured: Day 1 of study 2993-112 through extension study termination (up to Week 52)

  2. Change in body weight from Day 1 of Protocol 2993-112 to Week 52 (or termination)

    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.

    Measured: Day 1 of study 2993-112 through extension study termination (up to Week 52)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2013 (estimated)
  2. Study startSep 2002
  3. Primary completionJun 2004
  4. Study completionJun 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01789957
Sponsor's protocol ID
2993-112E
Status last verified
Jan 2015
First submitted
11 Feb 2013
Last updated
24 Feb 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AC2993 in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 226 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 226 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c from Day 1 of Protocol 2993-112 to Week 52 (or termination) (time frame: Day 1 of study 2993-112 through extension study termination (up to Week 52)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01789957.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2015.

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