Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus
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
1 other identifier
interventional
734
1 country
100
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2002
Shorter than P25 for phase_3
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 7, 2002
CompletedFirst Posted
Study publicly available on registry
May 8, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedFebruary 24, 2015
January 1, 2015
1.3 years
May 7, 2002
February 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c from Baseline to Week 30
Change in HbA1c from Baseline (Day 1) to study termination (Week 30)
Baseline (Day 1) to Week 30
Secondary Outcomes (6)
Change in HbA1c from baseline (Day 1) to each of the intermediate visits
Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24
The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30
Baseline (Day 1) and Week 30
The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30
Baseline (Day 1), and Week 30
The time to achieve specific HbA1c target values of < 7% and < 8%
Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30
The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more
Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30
- +1 more secondary outcomes
Study Arms (4)
AC2993 5 mcg (0.02 mL)
EXPERIMENTALPlacebo, then AC2993 5 mcg, then AC2993 5 mcg
AC2993 10mcg (0.04 mL)
EXPERIMENTALPlacebo, then AC2993 5 mcg, then AC2993 10 mcg
Placebo 0.02 mL
PLACEBO COMPARATORPlacebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL
Placebo 0.04 mL
PLACEBO COMPARATORPlacebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (100)
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
Medstar Clinical Research
Washington D.C., District of Columbia, 20003-4393, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
Medical Research Unlimited
Aventura, Florida, United States
Morton Plant Mease Health Care
Clearwater, Florida, 33756, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Internal Medicine Associates
Fort 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
Northwestern Memorial Physicians Group
Chicago, Illinois, 60602, United States
Illinois Center for Clinical Trials
Chicago, Illinois, 60610, United States
Cook County Hospital
Chicago, Illinois, 60612, 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
Kentucky Diabetes Center
Lexington, Kentucky, 40503, United States
Central Kentucky Research Associates
Lexington, Kentucky, 40509, 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
Midwest Pharmaceutical Research
City of Saint Peters, Missouri, 63376, 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
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
Thomas Jefferson University Diabetes Research Center
Philadelphia, Pennsylvania, 19107, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Philadelphia Health Associates
Philadelphia, Pennsylvania, 19146, 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
University of Texas Health Sciences Center-Texas Diabetes Institute
San Antonio, Texas, 78207, United States
Diabetes and Glandular Disease Clinic
San Antonio, Texas, 78229-3894, United States
SAM Clinical Research
San Antonio, Texas, 78229, United States
Utah Diabetes Center at the University of Utah
Salt Lake City, Utah, 84108, United States
Salt Lake Research
Salt Lake City, Utah, 84124, 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
Related Publications (3)
Kendall DM, Riddle MC, Rosenstock J, Zhuang D, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care. 2005 May;28(5):1083-91. doi: 10.2337/diacare.28.5.1083.
PMID: 15855571RESULTPencek 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.
PMID: 22913891DERIVEDFineman 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.
PMID: 22236356DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2002
First Posted
May 8, 2002
Study Start
May 1, 2002
Primary Completion
August 1, 2003
Study Completion
August 1, 2003
Last Updated
February 24, 2015
Record last verified: 2015-01