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

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

Condition(s) targeted: Diabetes Mellitus, Non-Insulin-Dependent

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 medications (metformin and a sulfonylurea) 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 Twice Daily in Subjects With Type 2 Diabetes Mellitus Treated With Metformin and a Sulfonylurea

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 from Baseline to 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 both metformin and 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%

Exclusion Criteria:

- Treated with oral anti-diabetic medications other than metformin and sulfonylurea

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

Parkway Medical Center, Birmingham, Alabama 35206, United States

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

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

First Care Family Doctors, Fayetteville, Arkansas 72701, United States

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

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

East Bay Clinical Trial Center, Concord, California, United States

Medical Group of Encino, Encino, California 91436, United States

Valley Research, Fresno, California 93720, United States

St. Joseph Heritage Healthcare, Fullerton, California 92835, United States

Whittier Institute for Diabetes, La Jolla, California 92037, United States

Richard Cherlin, M.D., Los Gatos, California 95032, United States

Dr. Martinez Medical Clinic, Moreno Valley, California 92553, United States

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

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

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

Diablo Clinical Research, Walnut Creek, California, United States

Creekside Endocrine Associates, Denver, Colorado 80209, United States

University of Colorado-Barbara Davis Center for Childhood Diabetes, Denver, Colorado 80262, United States

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

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

Medical Research Unlimited, Aventura, Florida, United States

Clinical Research of West Florida, Inc., Clearwater, Florida 33765, United States

Morton Plant Mease Health Care, Clearwater, Florida 33756, United States

Internal Medicine Associates, Ft. Myers, Florida, United States

Clin Sci International, Gainesville, Florida 32605, United States

Northeast Florida Endocrine & Diabetes Research, Jacksonville, Florida 32204, United States

Jupiter Research Institute, Jupiter, Florida 33458, United States

Baptist Diabetes Associates, Miami, Florida 33176, United States

Comprehensive NeuroScience Inc., Sarasota, Florida 34232, United States

Tallahassee Endocrine Associates, Tallahassee, Florida 32308, United States

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

Columbus Metabolic Foundation, Columbus, Georgia 31901, United States

University of Hawaii-Diabetes Research Group, Ewa Beach, Hawaii 96706, United States

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

Cook County Hospital, Chicago, Illinois 60612, United States

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

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

American Health Network, Indianapolis, Indiana 46222, United States

Indiana University Outpatient Clinical Research, Indianapolis, Indiana, United States

Lipid, Atherosclerosis & Metabolic Clinic, Kansas City, Kansas 66160, United States

Central Kentucky Research Associates, Lexington, Kentucky 40509, 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

New Orleans Center for Clinical Research, New Orleans, Louisiana 70119, United States

Ochsner Clinic, New Orleans, Louisiana 70121, United States

University of Maryland-Joslin Diabetes Center, Baltimore, Maryland 21012, United States

Clinica Research Inc., Waltham, Massachusetts 02154, United States

Henry Ford Health System, Detroit, Michigan, United States

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

International Diabetes Center, Minneapolis, Minnesota 55416, United States

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

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

Medical Arts Research Collaborative, Excelsior Springs, Missouri 64024, United States

St Lukes Lipid and Diabetes Research Center, Kansas City, Missouri 64111, 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

Lisa Abbott, MD, Reno, Nevada 89502, United States

SUNY Downstate, Brooklyn, New York 11203, 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

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

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

University Mednet, Mentor, Ohio 44060, United States

OU Health Sciences Center, Oklahoma City, Oklahoma 73104, United States

Medford Medical Clinic, Medford, Oregon 97504, United States

Radiant Research, Portland, Oregon, United States

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

Albert Einstein Medical Center, Philadelphia, Pennsylvania 19141, United States

Philadelphia Health Associates, Philadelphia, Pennsylvania 19146, United States

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

Medical University of South Carolina, Charleston, South Carolina 29425, United States

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

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

Holston Medical Group, Kingsport, Tennessee 37660, United States

The Endocrine Clinic, Memphis, Tennessee 38119, United States

Mid State Endocrine Associates, Nashville, Tennessee 37203, United States

Israel A. Hartman, M.D., Arlington, Texas 76014, United States

Dallas Diabetes and Endocrinology Research Center, Dallas, Texas 75230, United States

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

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

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

SAM Clinical Research, San Antonio, Texas 78229, 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

Utah Diabetes Center at the University of Utah, Salt Lake City, Utah 84108, United States

Medical Associates of Northern Virginia, Arlington, Virginia 22204, United States

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

Rockwood Clinic, Spokane, Washington 99202, United States

University of Wisconsin West Clinic, Madison, Wisconsin 53711, United States

Midwest Endocrinology Associates, Milwaukee, Wisconsin 53215, United States

Additional Information

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

Page last updated: August 20, 2015

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