Clinical trial NCT00039013: Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2002-06-10
Enrollment: 336
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in HbA1c (glycosylated hemoglobin) from baseline to study termination (Week 30)
timeFrame: Baseline (Day 1), Week 30
Secondary outcomes:
measure: Change in HbA1c from baseline (Day 1) to each of the intermediate visits
timeFrame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24
measure: The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30
timeFrame: Baseline (Day 1) and Week 30
measure: The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30
timeFrame: Baseline (Day 1), and Week 30
measure: The time to achieve specific HbA1c target values of < 7% and < 8%
timeFrame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30
measure: The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more
timeFrame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30
measure: Change in body weight from Baseline to each intermediate visit and Week 30
timeFrame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Birmingham
country: United States
facility: Parkway Medical Center
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Eclectic
country: United States
facility: Eclectic Family Care
state: Alabama
city: Haleyville
country: United States
facility: Winston Physician Services
state: Alabama
city: Hueytown
country: United States
facility: Simon Williamson Clinic
state: Alabama
city: Montgomery
country: United States
facility: Extended Arm Physicians/ Southern Drug
state: Alabama
city: Tallassee
country: United States
facility: Southern Drug Research Network
state: Alabama
city: Mesa
country: United States
facility: Clinic of Physicians and Surgeons, Ltd.
state: Arizona
city: Mesa
country: United States
facility: ANA Ventures, LLC
state: Arizona
city: Phoenix
country: United States
facility: Lovelace Scientific Resources-Phoenix
state: Arizona
city: Phoenix
country: United States
facility: Physicians at the Peak
state: Arizona
city: Tucson
country: United States
facility: Advanced Clinical Therapeutics
state: Arizona
city: Little Rock
country: United States
facility: CAVHS
state: Arkansas
city: Little Rock
country: United States
facility: Physicians Group Research Clinic, LLC
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Bakersfield
country: United States
facility: Mitchell Research Group, Inc.
state: California
city: Burlingame
country: United States
facility: William Zigrang, M.D.
state: California
city: Chula Vista
country: United States
facility: International Clinical Research Network
state: California
city: Colton
country: United States
facility: Arrowhead Regional Medical Center
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Rancho Mirage
country: United States
facility: Elke Jost-Vu, M.D.
state: California
city: Redwood City
country: United States
facility: Comprehensive Diabetes-Endocrine Medical Associates
state: California
city: San Diego
country: United States
facility: nTouch
state: California
city: San Diego
country: United States
facility: Radiant Research-San Diego
state: California
city: San Diego
country: United States
facility: Veterans Medical Research Foundation
state: California
city: San Mateo
country: United States
facility: Diabetes Research Institute of Mills Peninsula
state: California
city: Santa Ana
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Signal Hill
country: United States
facility: West Coast Clinical Trials
state: California
city: Vista
country: United States
facility: Protocare Trials at Sharp Mission Park
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Washington
country: United States
facility: Medstar Clinical Research
state: District of Columbia
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Ft. Myers
country: United States
facility: Internal Medical Associates
state: Florida
city: Gainesville
country: United States
facility: Clin Sci International
state: Florida
city: Gainesville
country: United States
facility: University of FL
state: Florida
city: Jupiter
country: United States
facility: Jupiter Research Institute
state: Florida
city: Miami
country: United States
facility: Baptist Diabetes Associates
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Radiant Research
state: Florida
city: Decatur
country: United States
facility: nTouch Research Corporation
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Meridian
country: United States
facility: St. Luke's Family Health
state: Idaho
city: Belvidere
country: United States
facility: University Primary Care Center at Belvidere
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Physicians Group
state: Illinois
city: Chicago
country: United States
facility: Illinois Center for Clinical Trials
state: Illinois
city: Libertyville
country: United States
facility: Lake Forest Internal Medicine
state: Illinois
city: Libertyville
country: United States
facility: Winchester Research Group
state: Illinois
city: Fort Wayne
country: United States
facility: Medical Group of Fort Wayne
state: Indiana
city: Indianapolis
country: United States
facility: American Health Network
state: Indiana
city: Indianapolis
country: United States
facility: Center for Metabolic and Hormonal Disorders
state: Indiana
city: South Bend
country: United States
facility: nTouch Research-South Bend
state: Indiana
city: Lexington
country: United States
facility: Kentucky Diabetes Center
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Metabolic Research Group
state: Kentucky
city: Louisville
country: United States
facility: MedResearch, Inc.
state: Kentucky
city: Metairie
country: United States
facility: Drug Research Services
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans Institute of Clinical Investigation
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Baltimore
country: United States
facility: St. Agnes Health Care
state: Maryland
city: Lanham
country: United States
facility: Doctors Research Associates of Maryland
state: Maryland
city: Bloomfield Hills
country: United States
facility: Grunberger Diabetes Medical Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Grand Rapids Associated Interns
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Chesterfield
country: United States
facility: Diabetes and Endocrinology Specialists
state: Missouri
city: Rolla
country: United States
facility: Mid Missouri Research Specialists, Inc.
state: Missouri
city: St. Louis
country: United States
facility: Radiant Research-St. Louis
state: Missouri
city: St. Peters
country: United States
facility: Midwest Pharmaceutical Research
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical
state: Montana
city: Las Vegas
country: United States
facility: Lovelace Scientific Resources-Las Vegas
state: Nevada
city: Jersey City
country: United States
facility: HIS Clinical Research
state: New Jersey
city: Moorestown
country: United States
facility: Radiant Research-Moorestown
state: New Jersey
city: Passaic
country: United States
facility: New Jersey Physicians
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources
state: New Mexico
city: Brooklyn
country: United States
facility: Medical Network Services, P.C.
state: New York
city: New York
country: United States
facility: St. Lukes Roosevelt Hospital
state: New York
city: New York
country: United States
facility: Naomi Berrie Diabetes Center at Columbia University
state: New York
city: New York
country: United States
facility: Heights Medical Care
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Yonkers
country: United States
facility: DOCS at Beth Israel Medical Center
state: New York
city: Charlotte
country: United States
facility: Metrolina Medical Research
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Clinical Research
state: North Carolina
city: Durham
country: United States
facility: UNC Diabetes Care Center
state: North Carolina
city: Hickory
country: United States
facility: Unifour Medical Research
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Medical Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research
state: Ohio
city: Columbus
country: United States
facility: Ohio State University-Division of Endocrinology
state: Ohio
city: Columbus
country: United States
facility: Radiant Research-Columbus
state: Ohio
city: Mentor
country: United States
facility: University Mednet
state: Ohio
city: Oklahoma City
country: United States
facility: COR Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: nTouch Research Corporation-Oklahoma City
state: Oklahoma
city: Tulsa
country: United States
facility: Utica Park Clinic
state: Oklahoma
city: Medford
country: United States
facility: Medford Medical Clinic
state: Oregon
city: Portland
country: United States
facility: Legacy Clinical Research
state: Oregon
city: Portland
country: United States
facility: Radiant Research
state: Oregon
city: Camp Hill
country: United States
facility: Physicians for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Diabetes Research Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Health Associates
state: Pennsylvania
city: Tipton
country: United States
facility: Tipton Medical and Diagnostic Center
state: Pennsylvania
city: East Providence
country: United States
facility: Safe Harbor Clinical Research
state: Rhode Island
city: Charleston
country: United States
facility: Radiant Research-Charleston
state: South Carolina
city: Chester
country: United States
facility: CNS Clinical Trials
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Jackson
country: United States
facility: Integrity Clinical Research
state: Tennessee
city: Johnson City
country: United States
facility: Harmony Clinical Research
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Knoxville
country: United States
facility: Endocrine Consultants of ET
state: Tennessee
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Dallas
country: United States
facility: Rafael Canadas M.D., P.A.
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences-Internal Medicine
state: Texas
city: El Paso
country: United States
facility: Internal Medicine Associates
state: Texas
city: Irving
country: United States
facility: North Texas Clinical Research
state: Texas
city: Kingsville
country: United States
facility: Dr. Humberto Bruschetta
state: Texas
city: McAllen
country: United States
facility: South Texas Applied Research
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center-Texas Diabetes Institute
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Clinic
state: Texas
city: San Antonio
country: United States
facility: SAM Clinical Research Center
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
city: Kirkland
country: United States
facility: Evergreen Diabetes & Endocrinology
state: Washington
city: Olympia
country: United States
facility: West Olympia Internal Medicine
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Spokane
country: United States
facility: Northside Internal Medicine
state: Washington
city: Spokane
country: United States
facility: Rockwood Clinic
state: Washington
city: Spokane
country: United States
facility: Julia M. Hutchinson, M.D.
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Clinic
state: Washington
city: Charleston
country: United States
facility: Hyperion Clinical Research
state: West Virginia
city: Charleston
country: United States
facility: CAMC Clinical Trials Center
state: West Virginia
Study officials:
References:
citation: 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.
citation: Ratner 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.
citation: 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.
citation: 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.