Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
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
1 other identifier
interventional
336
1 country
129
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 medication (metformin) throughout the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Mar 2002
129 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
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 6, 2002
CompletedFirst Posted
Study publicly available on registry
June 10, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2003
CompletedFebruary 24, 2015
January 1, 2015
1.3 years
June 6, 2002
February 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c (glycosylated hemoglobin) from baseline to study termination (Week 30)
Change in HbA1c from from baseline, measured from Visit 3 (Day 1) to study termination (Week 30).
Baseline (Day 1), 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 / Placebo (0.02 mL) for 4 weeks / Placebo (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 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%
You may not qualify if:
- Treated with oral anti-diabetic medications other than metformin 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 (129)
Pinnacle Research Group
Anniston, Alabama, 36207, United States
Parkway Medical Center
Birmingham, Alabama, 35206, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, 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
Clinic of Physicians and Surgeons, Ltd.
Mesa, Arizona, 85201, United States
ANA Ventures, LLC
Mesa, Arizona, 85204, 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
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
Internal Medical Associates
Fort 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
Northwestern Memorial Physicians Group
Chicago, Illinois, 60602, United States
Illinois Center for Clinical Trials
Chicago, Illinois, 60610, 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
Midwest Pharmaceutical Research
City of Saint Peters, Missouri, 63376, 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
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
St. Lukes Roosevelt Hospital
New York, New York, 10025, United States
Naomi Berrie Diabetes Center at Columbia University
New York, New York, 10032, United States
Heights Medical Care
New York, New York, 10033, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
DOCS at Beth Israel Medical Center
Yonkers, New York, 10710, United States
Metrolina Medical Research
Charlotte, North Carolina, 28209, 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
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
Thomas Jefferson University Diabetes Research Center
Philadelphia, Pennsylvania, 19107, United States
Philadelphia Health Associates
Philadelphia, Pennsylvania, 19146, 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
Texas Tech University Health Sciences-Internal Medicine
El Paso, Texas, 79905, United States
Internal Medicine Associates
El Paso, Texas, 79912, 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
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 Center
San Antonio, Texas, 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
Northside Internal Medicine
Spokane, Washington, 99201, United States
Rockwood Clinic
Spokane, Washington, 99202, United States
Julia M. Hutchinson, M.D.
Spokane, Washington, 99204, United States
Wenatchee Valley Clinic
Wenatchee, Washington, 98801, United States
Hyperion Clinical Research
Charleston, West Virginia, 25301, United States
CAMC Clinical Trials Center
Charleston, West Virginia, 25304, United States
Related Publications (4)
DeFronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005 May;28(5):1092-100. doi: 10.2337/diacare.28.5.1092.
PMID: 15855572RESULTRatner RE, Maggs D, Nielsen LL, Stonehouse AH, Poon T, Zhang B, Bicsak TA, Brodows RG, Kim DD. Long-term effects of exenatide therapy over 82 weeks on glycaemic control and weight in over-weight metformin-treated patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2006 Jul;8(4):419-28. doi: 10.1111/j.1463-1326.2006.00589.x.
PMID: 16776749RESULTPencek 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
June 6, 2002
First Posted
June 10, 2002
Study Start
March 1, 2002
Primary Completion
June 1, 2003
Study Completion
June 1, 2003
Last Updated
February 24, 2015
Record last verified: 2015-01