Clinical trial NCT00035984: Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Type 2 Diabetes Mellitis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2002-05-08
Enrollment: 734
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 medications (metformin and a sulfonylurea) throughout the study.


Eligibility 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

Primary outcomes:
measure: Change in HbA1c from Baseline to Week 30
timeFrame: Baseline (Day 1) to 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: 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: Fayetteville
country: United States
facility: First Care Family Doctors
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: Concord
country: United States
facility: East Bay Clinical Trial Center
state: California
city: Encino
country: United States
facility: Medical Group of Encino
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: La Jolla
country: United States
facility: Whittier Institute for Diabetes
state: California
city: Los Gatos
country: United States
facility: Richard Cherlin, M.D.
state: California
city: Moreno Valley
country: United States
facility: Dr. Martinez Medical Clinic
state: California
city: Redwood City
country: United States
facility: Comprehensive Diabetes-Endocrine Medical Associates
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: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Denver
country: United States
facility: Creekside Endocrine Associates
state: Colorado
city: Denver
country: United States
facility: University of Colorado-Barbara Davis Center for Childhood Diabetes
state: Colorado
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: Aventura
country: United States
facility: Medical Research Unlimited
state: Florida
city: Clearwater
country: United States
facility: Morton Plant Mease Health Care
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Ft. Myers
country: United States
facility: Internal Medicine Associates
state: Florida
city: Gainesville
country: United States
facility: Clin Sci International
state: Florida
city: Jacksonville
country: United States
facility: Northeast Florida Endocrine & Diabetes Research
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: Sarasota
country: United States
facility: Comprehensive NeuroScience Inc.
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Endocrine Associates
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Columbus
country: United States
facility: Columbus Metabolic Foundation
state: Georgia
city: Ewa Beach
country: United States
facility: University of Hawaii-Diabetes Research Group
state: Hawaii
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: Chicago
country: United States
facility: Cook County Hospital
state: Illinois
city: Indianapolis
country: United States
facility: American Health Network
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Outpatient Clinical Research
state: Indiana
city: Kansas City
country: United States
facility: Lipid, Atherosclerosis & Metabolic Clinic
state: Kansas
city: Lexington
country: United States
facility: Kentucky Diabetes Center
state: Kentucky
city: Lexington
country: United States
facility: Central Kentucky Research Associates
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: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland-Joslin Diabetes Center
state: Maryland
city: Waltham
country: United States
facility: Clinica Research Inc.
state: Massachusetts
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: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
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: Excelsior Springs
country: United States
facility: Medical Arts Research Collaborative
state: Missouri
city: Kansas City
country: United States
facility: St Lukes Lipid and Diabetes Research Center
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: Reno
country: United States
facility: Lisa Abbott, MD
state: Nevada
city: Brooklyn
country: United States
facility: SUNY Downstate
state: New York
city: New York
country: United States
facility: St. Lukes Roosevelt Hospital
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: 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: 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: OU Health Sciences Center
state: Oklahoma
city: Medford
country: United States
facility: Medford Medical Clinic
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: Albert Einstein Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Health Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
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: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Memphis
country: United States
facility: The Endocrine Clinic
state: Tennessee
city: Nashville
country: United States
facility: Mid State Endocrine Associates
state: Tennessee
city: Arlington
country: United States
facility: Israel A. Hartman, M.D.
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrinology Research Center
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences-Internal Medicine
state: Texas
city: Irving
country: United States
facility: North Texas Clinical 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
state: Texas
city: Salt Lake City
country: United States
facility: Utah Diabetes Center at the University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
city: Arlington
country: United States
facility: Medical Associates of Northern Virginia
state: Virginia
city: Olympia
country: United States
facility: West Olympia Internal Medicine
state: Washington
city: Spokane
country: United States
facility: Rockwood Clinic
state: Washington
city: Madison
country: United States
facility: University of Wisconsin West Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: Midwest Endocrinology Associates
state: Wisconsin
Study officials:
References:
citation: 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.
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.