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Diabetes Mellitus, Non-Insulin-DependentPhase 3NCT00039026

Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With a Sulfonylurea

A Phase 3 study testing AC2993 in people with Diabetes Mellitus, Non-Insulin-Dependent, run by AstraZeneca at 126 sites in United States.

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 is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing… Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Diabetes Mellitus, Non-Insulin-Dependent
What is being tested?
AC2993
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
377 participants
Where
126 sitesUnited States
Study dates
Feb 2002to Aug 2003
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

Who may be able to join

  • Subjects with Type 2 diabetes mellitus
  • Treated with a sulfonylurea at defined doses for at least 3 months prior to screening
  • BMI= 27-45 kg/m2
  • HbA1c value between 7.5% and 11%

Who cannot join

  • Treated with oral anti-diabetic medications other than a sulfonylurea within 3 months of screening
  • Patients treated previously with AC2993
  • Patients presently treated with insulin

Trial locations and contacts

126 sites in 1 country.

126 sites in 1 country

United States126 sites

  • Lovelace Scientific Resources

    Albuquerque, New Mexico, 87108

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • Clinical Research Atlanta

    Atlanta, Georgia, 30342

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Mitchell Research Group, Inc.

    Bakersfield, California, 93309

  • St. Agnes Health Care

    Baltimore, Maryland, 21229

  • 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

  • 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

  • Radiant Research-Charleston

    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 Memorial Physicians Group

    Chicago, Illinois, 60602

  • Illinois Center for Clinical Trials

    Chicago, Illinois, 60610

  • International Clinical Research Network

    Chula Vista, California, 91910

  • Midwest Pharmaceutical Research

    City of Saint Peters, Missouri, 63376

  • Rapid Medical Research

    Cleveland, Ohio, 44124

  • Arrowhead Regional Medical Center

    Colton, California, 92324

  • Ohio State University-Division of Endocrinology

    Columbus, Ohio, 43210

  • Radiant Research-Columbus

    Columbus, Ohio, 43212

  • East Bay Clinical Trial Center

    Concord, California

  • nTouch Research Corporation

    Decatur, Georgia, 30033

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • UNC Diabetes Care Center

    Durham, North Carolina, 27713

  • Safe Harbor Clinical Research

    East Providence, Rhode Island, 02914

  • Eclectic Family Care

    Eclectic, Alabama, 36024

  • Texas Tech University Health Sciences-Internal Medicine

    El Paso, Texas, 79905

  • Internal Medicine Associates

    El Paso, Texas, 79912

  • Internal Medicine Associates

    Fort Myers, Florida, 33901

  • Medical Group of Fort Wayne

    Fort Wayne, Indiana, 46804

  • 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

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96813

  • Simon Williamson Clinic

    Hueytown, Alabama, 35023

  • American Health Network

    Indianapolis, Indiana, 46222

  • North Texas Clinical Research

    Irving, Texas, 75038

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Integrity Clinical Research

    Jackson, Tennessee, 38305

  • HIS Clinical Research

    Jersey City, New Jersey, 07306

  • Harmony Clinical Research

    Johnson City, Tennessee, 37601

  • Jupiter Research Institute

    Jupiter, Florida, 33458

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Dr. Humberto Bruschetta

    Kingsville, Texas, 78363

  • Endocrine Consultants of ET

    Knoxville, Tennessee, 37909

  • Doctors Research Associates of Maryland

    Lanham, Maryland, 20706

  • Lovelace Scientific Resources-Las Vegas

    Las Vegas, Nevada, 89102

  • Kentucky Diabetes Center

    Lexington, Kentucky, 40503

  • University of Kentucky Metabolic Research Group

    Lexington, Kentucky, 40536-9841

  • CAVHS

    Little Rock, Arkansas, 72205

  • Physicians Group Research Clinic, LLC

    Little Rock, Arkansas, 72205

  • MedResearch, Inc.

    Louisville, Kentucky, 40223

  • South Texas Applied Research

    McAllen, Texas, 78503

  • Medford Medical Clinic

    Medford, Oregon, 97504

  • 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

  • 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

    Moorestown, New Jersey, 08057

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • New Orleans Institute of Clinical Investigation

    New Orleans, Louisiana, 70112

  • Ochsner Clinic

    New Orleans, Louisiana, 70121

  • St. Lukes Roosevelt Hospital

    New York, New York, 10025

  • Naomi Berrie Diabetes Center at Columbia University

    New York, New York, 10032

  • Heights Medical Care

    New York, New York, 10033

  • Clinical Research Center-Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • COR Clinical Research

    Oklahoma City, Oklahoma, 73103

  • nTouch Research Corporation-Oklahoma City

    Oklahoma City, Oklahoma, 73112

  • West Olympia Internal Medicine

    Olympia, Washington, 98502

  • Thomas Jefferson University Diabetes Research Center

    Philadelphia, Pennsylvania, 19107

  • Philadelphia Health Associates

    Philadelphia, Pennsylvania, 19146

  • Lovelace Scientific Resources-Phoenix

    Phoenix, Arizona, 85016

  • Physicians at the Peak

    Phoenix, Arizona, 85020

  • Legacy Clinical Research

    Portland, Oregon, 97232

  • Radiant Research

    Portland, Oregon

  • 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

  • Mid Missouri Research Specialists, Inc.

    Rolla, Missouri, 65401

  • Salt Lake Research

    Salt Lake City, Utah, 84124

  • 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 Center

    San Antonio, Texas

  • nTouch

    San Diego, California, 92103

  • Radiant Research-San Diego

    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

  • West Coast Clinical Trials

    Signal Hill, California, 90755

  • nTouch Research-South Bend

    South Bend, Indiana, 46601

  • Northside Internal Medicine

    Spokane, Washington, 99201

  • Rockwood Clinic

    Spokane, Washington, 99202

  • Julia M. Hutchinson, M.D.

    Spokane, Washington, 99204

  • Radiant Research-St. Louis

    St Louis, Missouri, 63141

  • Southern Drug Research Network

    Tallassee, Alabama, 36078

  • Tampa Medical Group

    Tampa, Florida, 33614

  • Tipton Medical and Diagnostic Center

    Tipton, Pennsylvania, 16684

  • Advanced Clinical Therapeutics

    Tucson, Arizona, 85712

  • Utica Park Clinic

    Tulsa, Oklahoma, 74104

  • Protocare Trials at Sharp Mission Park

    Vista, California, 92083

  • Diablo Clinical Research

    Walnut Creek, California, 94598

  • George Washington University

    Washington D.C., District of Columbia, 20037

  • Wenatchee Valley Clinic

    Wenatchee, Washington, 98801

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

  • Radiant Research

    West Palm Beach, Florida, 33407

  • 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

About this study

Official title: A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus Treated With a Sulfonylurea Alone

This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medication (sulfonylurea) throughout the study.

Being tested
AC2993, Placebo
Keywords
Type 2 Diabetes Mellitis
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 synthetic exendin-4

    Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily

  • AC2993Drug

    Also called synthetic exendin-4

    Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily

  • PlaceboDrug

    Placebo Lead In (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily

  • PlaceboDrug

    Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily

Study groups in NCT00039026
Study groupRoleWhat they receive
AC2993 5 mcg (0.02 mL)ExperimentalPlacebo, then AC2993 5 mcg, then AC2993 5 mcg
Receives: Drug: AC2993
AC2993 10mcg (0.04 mL)ExperimentalPlacebo, then AC2993 5 mcg, then AC2993 10 mcg
Receives: Drug: AC2993
Placebo 0.02 mLPlacebo comparatorPlacebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL
Receives: Drug: Placebo
Placebo 0.04 mLPlacebo comparatorPlacebo 0.02 mL / Placebo 0.02 mL / Placebo 0.04 mL
Receives: Drug: Placebo

What is being measured

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

  1. Change in HbA1c from Baseline to Week 30

    Change in HbA1c from Baseline (Day 1) to study termination (Week 30)

    Measured: Baseline (Day 1) to Week 30

Secondary outcomes (6)

  1. Change in HbA1c from baseline (Day 1) to each of the intermediate visits

    Change in HbA1c from baseline, measured from Visit 3 (Day 1) to each of the intermediate visits (Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, and Week 24

    Measured: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24

  2. The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30

    The number of subjects achieving HbA1c target values of < 7% and < 8% by study termination (Week 30)

    Measured: Baseline (Day 1) and Week 30

  3. The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30

    The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by study termination (Week 30)

    Measured: Baseline (Day 1), and Week 30

  4. The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more

    The time it takes subjects to achieve HbA1c reductions of 0.5% or more and >1.0% or more

    Measured: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30

  5. The time to achieve specific HbA1c target values of < 7% and < 8%

    The time it takes subjects to achieve HbA1c target values of < 7% and < 8%

    Measured: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30

  6. Change in body weight from Baseline to each intermediate visit and Week 30

    Change in body weight (kg) from Baseline to each intermediate visit and Week 30

    Measured: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30

Timeline

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

  1. First posted10 Jun 2002 (estimated)
  2. Study startFeb 2002
  3. Primary completionAug 2003
  4. Study completionAug 2003

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
377 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00039026
Sponsor's protocol ID
2993-113
Status last verified
Jan 2015
First submitted
6 Jun 2002
Last updated
24 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • Buse JB, Henry RR, Han J, Kim DD, Fineman MS, Baron AD; Exenatide-113 Clinical Study Group. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care. 2004 Nov;27(11):2628-35. doi: 10.2337/diacare.27.11.2628.

    PubMed 15504997

  • Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.

    PubMed 22913891

  • Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.

    PubMed 22236356

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AC2993 in people with Diabetes Mellitus, Non-Insulin-Dependent, run by AstraZeneca at 126 sites in United States.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. 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 126 sites in United States. 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. Some participants in this study may receive a placebo. 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 Baseline to Week 30 (time frame: Baseline (Day 1) to Week 30). 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 NCT00039026, which also lists 3 linked publications.

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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