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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: AC2993 (Drug); AC2993 (Drug); Placebo (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

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 diabetes medication (metformin) throughout the study.

Clinical Details

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 Metformin Alone

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in HbA1c (glycosylated hemoglobin) from baseline to study termination (Week 30)

Secondary outcome:

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

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

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

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

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

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

Eligibility

Minimum age: 16 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects with Type 2 diabetes mellitus

- Treated with metformin within a defined dose range for at least 3 months prior to

screening

- BMI= 27-45 kg/m2

- HbA1c value between 7. 5% and 11%

Exclusion Criteria:

- Treated with oral anti-diabetic medications other than metformin within 3 months of

screening

- Patients treated previously with AC2993

- Patients presently treated with insulin

Locations and Contacts

Pinnacle Research Group, Anniston, Alabama 36207, United States

Alabama Clinical Therapeutics, Birmingham, Alabama 35235, United States

Parkway Medical Center, Birmingham, Alabama 35206, United States

Eclectic Family Care, Eclectic, Alabama 36024, United States

Winston Physician Services, Haleyville, Alabama 35565, United States

Simon Williamson Clinic, Hueytown, Alabama 35023, United States

Extended Arm Physicians/ Southern Drug, Montgomery, Alabama 36106, United States

Southern Drug Research Network, Tallassee, Alabama 36078, United States

ANA Ventures, LLC, Mesa, Arizona 85204, United States

Clinic of Physicians and Surgeons, Ltd., Mesa, Arizona 85201, United States

Lovelace Scientific Resources-Phoenix, Phoenix, Arizona 85016, United States

Physicians at the Peak, Phoenix, Arizona 85020, United States

Advanced Clinical Therapeutics, Tucson, Arizona 85712, United States

CAVHS, Little Rock, Arkansas 72205, United States

Physicians Group Research Clinic, LLC, Little Rock, Arkansas 72205, United States

Advanced Clinical Research Institute, Anaheim, California 92801, United States

Mitchell Research Group, Inc., Bakersfield, California 93309, United States

William Zigrang, M.D., Burlingame, California 94010, United States

International Clinical Research Network, Chula Vista, California 91910, United States

Arrowhead Regional Medical Center, Colton, California 92324, United States

Valley Research, Fresno, California 93720, United States

Elke Jost-Vu, M.D., Rancho Mirage, California 92270, United States

Comprehensive Diabetes-Endocrine Medical Associates, Redwood City, California 94062, United States

nTouch, San Diego, California 92103, United States

Radiant Research-San Diego, San Diego, California 92108, United States

Veterans Medical Research Foundation, San Diego, California 92161, United States

Diabetes Research Institute of Mills Peninsula, San Mateo, California 94401, United States

Advanced Clinical Research Institute, Santa Ana, California 92701, United States

West Coast Clinical Trials, Signal Hill, California 90755, United States

Protocare Trials at Sharp Mission Park, Vista, California 92083, United States

Diablo Clinical Research, Walnut Creek, California 94598, United States

George Washington University, Washington, District of Columbia 20037, United States

Medstar Clinical Research, Washington, District of Columbia 20003-4393, United States

Internal Medical Associates, Ft. Myers, Florida 33901, United States

Clin Sci International, Gainesville, Florida 32605, United States

University of FL, Gainesville, Florida 32610-0226, United States

Jupiter Research Institute, Jupiter, Florida 33458, United States

Baptist Diabetes Associates, Miami, Florida 33176, United States

Tampa Medical Group, Tampa, Florida 33614, United States

Metabolic Research Institute, Inc., West Palm Beach, Florida 33401, United States

Radiant Research, West Palm Beach, Florida 33407, United States

nTouch Research Corporation, Decatur, Georgia 30033, United States

East-West Medical Research Institute, Honolulu, Hawaii 96813, United States

St. Luke's Family Health, Meridian, Idaho 83642, United States

University Primary Care Center at Belvidere, Belvidere, Illinois 61008, United States

Illinois Center for Clinical Trials, Chicago, Illinois 60610, United States

Northwestern Memorial Physicians Group, Chicago, Illinois 60602, United States

Lake Forest Internal Medicine, Libertyville, Illinois 60048, United States

Winchester Research Group, Libertyville, Illinois 60048, United States

Medical Group of Fort Wayne, Fort Wayne, Indiana 46804, United States

American Health Network, Indianapolis, Indiana 46222, United States

Center for Metabolic and Hormonal Disorders, Indianapolis, Indiana 46260, United States

nTouch Research-South Bend, South Bend, Indiana 46601, United States

Kentucky Diabetes Center, Lexington, Kentucky 40503, United States

University of Kentucky Metabolic Research Group, Lexington, Kentucky 40536-9841, United States

MedResearch, Inc., Louisville, Kentucky 40223, United States

Drug Research Services, Metairie, Louisiana 70001, United States

New Orleans Institute of Clinical Investigation, New Orleans, Louisiana 70112, United States

Ochsner Clinic, New Orleans, Louisiana 70121, United States

St. Agnes Health Care, Baltimore, Maryland 21229, United States

Doctors Research Associates of Maryland, Lanham, Maryland 20706, United States

Grunberger Diabetes Medical Center, Bloomfield Hills, Michigan 48302, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

Grand Rapids Associated Interns, Grand Rapids, Michigan 49506, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216, United States

Diabetes and Endocrinology Specialists, Chesterfield, Missouri 63017, United States

Mid Missouri Research Specialists, Inc., Rolla, Missouri 65401, United States

Radiant Research-St. Louis, St. Louis, Missouri 63141, United States

Midwest Pharmaceutical Research, St. Peters, Missouri 63376, United States

Mercury Street Medical, Butte, Montana 59701, United States

Lovelace Scientific Resources-Las Vegas, Las Vegas, Nevada 89102, United States

HIS Clinical Research, Jersey City, New Jersey 07306, United States

Radiant Research-Moorestown, Moorestown, New Jersey 08057, United States

New Jersey Physicians, Passaic, New Jersey 07055, United States

Lovelace Scientific Resources, Albuquerque, New Mexico 87108, United States

Medical Network Services, P.C., Brooklyn, New York 11230, United States

Heights Medical Care, New York, New York 10033, United States

Naomi Berrie Diabetes Center at Columbia University, New York, New York 10032, United States

St. Lukes Roosevelt Hospital, New York, New York 10025, United States

Rochester Clinical Research, Rochester, New York 14609, United States

DOCS at Beth Israel Medical Center, Yonkers, New York 10710, United States

Charlotte Clinical Research, Charlotte, North Carolina 28211, United States

Metrolina Medical Research, Charlotte, North Carolina 28209, United States

UNC Diabetes Care Center, Durham, North Carolina 27713, United States

Unifour Medical Research, Hickory, North Carolina 28601, United States

New Hanover Medical Research Associates, Wilmington, North Carolina 28412, United States

Piedmont Medical Research, Winston-Salem, North Carolina 27103, United States

Rapid Medical Research, Cleveland, Ohio 44124, United States

Ohio State University-Division of Endocrinology, Columbus, Ohio 43210, United States

Radiant Research-Columbus, Columbus, Ohio 43212, United States

University Mednet, Mentor, Ohio 44060, United States

COR Clinical Research, Oklahoma City, Oklahoma 73103, United States

nTouch Research Corporation-Oklahoma City, Oklahoma City, Oklahoma 73112, United States

Utica Park Clinic, Tulsa, Oklahoma 74104, United States

Medford Medical Clinic, Medford, Oregon 97504, United States

Legacy Clinical Research, Portland, Oregon 97232, United States

Radiant Research, Portland, Oregon, United States

Physicians for Clinical Research, Camp Hill, Pennsylvania 17011, United States

Philadelphia Health Associates, Philadelphia, Pennsylvania 19146, United States

Thomas Jefferson University Diabetes Research Center, Philadelphia, Pennsylvania 19107, United States

Tipton Medical and Diagnostic Center, Tipton, Pennsylvania 16684, United States

Safe Harbor Clinical Research, East Providence, Rhode Island 02914, United States

Radiant Research-Charleston, Charleston, South Carolina 29407, United States

CNS Clinical Trials, Chester, South Carolina 29706, United States

Coastal Carolina Research Center, Mt. Pleasant, South Carolina 29464, United States

Integrity Clinical Research, Jackson, Tennessee 38305, United States

Harmony Clinical Research, Johnson City, Tennessee 37601, United States

Holston Medical Group, Kingsport, Tennessee 37660, United States

Endocrine Consultants of ET, Knoxville, Tennessee 37909, United States

Central Texas Clinical Research, Austin, Texas 78705, United States

Rafael Canadas M.D., P.A., Dallas, Texas 75251, United States

Internal Medicine Associates, El Paso, Texas 79912, United States

Texas Tech University Health Sciences-Internal Medicine, El Paso, Texas 79905, United States

North Texas Clinical Research, Irving, Texas 75038, United States

Dr. Humberto Bruschetta, Kingsville, Texas 78363, United States

South Texas Applied Research, McAllen, Texas 78503, United States

Diabetes and Glandular Disease Clinic, San Antonio, Texas 78229-3894, United States

SAM Clinical Research Center, San Antonio, Texas, United States

University of Texas Health Sciences Center-Texas Diabetes Institute, San Antonio, Texas 78207, United States

Salt Lake Research, Salt Lake City, Utah 84124, United States

Evergreen Diabetes & Endocrinology, Kirkland, Washington 98034, United States

West Olympia Internal Medicine, Olympia, Washington 98502, United States

Rainier Clinical Research Center, Renton, Washington 98055, United States

Julia M. Hutchinson, M.D., Spokane, Washington 99204, United States

Northside Internal Medicine, Spokane, Washington 99201, United States

Rockwood Clinic, Spokane, Washington 99202, United States

Wenatchee Valley Clinic, Wenatchee, Washington 98801, United States

CAMC Clinical Trials Center, Charleston, West Virginia 25304, United States

Hyperion Clinical Research, Charleston, West Virginia 25301, United States

Additional Information

Starting date: March 2002
Last updated: February 23, 2015

Page last updated: August 20, 2015

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