Clinical trial NCT01789957: Extension Study for 2993-112
Official title: An Open-Label Extension Study of Protocol 2993-112 to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of AC2993 Given Two Times a Day to Subjects Treated With Metformin Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-02-12
Enrollment: 225
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multicenter, open-label extension study of Protocol 2993-112 is designed to assess long-term glucose control as measured by HbA1c (glycosylated hemoglobin) and to evaluate long-term safety and tolerability in subjects treated with metformin who receive subcutaneously injected AC2993 (10 mcg) administered twice daily. Subjects completing Protocol 2993-112 are eligible to enroll.


Eligibility criteria: All of the following criteria are to be fulfilled for inclusion of an individual in the study unless the sponsor grants an exception:

* Has completed the 30-week triple-blind treatment initiation/active treatment periods in Protocol 2993-112, including all procedures required at the study termination visit (Week 30).
* Male or female. Female individuals must be either 1) postmenopausal as documented by serum FSH measurement unless using estrogen for hormone replacement therapy; or 2) of childbearing potential and used appropriate contraceptive methods (surgical sterility or oral, injected, barrier, intrauterine, or implanted contraceptives) for the duration of Protocol 2993-112. This individual must have a current, negative pregnancy test (human chorionic gonadotropin \[HCG\], beta subunit) regardless of birth control method used. The individual agrees to continue using birth control throughout the study to prevent pregnancy.
* Able to understand and sign a Protocol 2993-112E-specific informed consent form, communicate with the investigator, and understand and comply with the protocol requirements.

Individuals meeting any of the following criteria are to be excluded from the study unless the sponsor grants an exception:

* Has not completed Protocol 2993-112.
* Female individuals who are pregnant, lactating, or planning to become pregnant.

Primary outcomes:
measure: Change in HbA1c from Day 1 of Protocol 2993-112 to Week 52 (or termination)
timeFrame: Day 1 of study 2993-112 through extension study termination (up to Week 52)
measure: Change in body weight from Day 1 of Protocol 2993-112 to Week 52 (or termination)
timeFrame: Day 1 of study 2993-112 through extension study termination (up to Week 52)
Secondary outcomes:
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: Chandler
country: United States
facility: Mesa Center for Clinical Research
state: Arizona
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
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: Fayetteville
country: United States
facility: First Care Family Doctors
state: Arkansas
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: Atherton
country: United States
facility: Endocrine Metabolic Medical Center
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: 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: Fremont
country: United States
facility: Mowry Clinical Research
state: California
city: Fresno
country: United States
facility: SARC Research Center
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Irvine
country: United States
facility: Irvine Clinical Research Center
state: California
city: La Jolla
country: United States
facility: Whittier Institute for Diabetes
state: California
city: Long Beach
country: United States
facility: Harriman Jones Medical Group
state: California
city: Los Gatos
country: United States
facility: Richard Cherlin, M.D.
state: California
city: Modesto
country: United States
facility: Tushar Modi, M.D.
state: California
city: Moreno Valley
country: United States
facility: Dr. Martinez Medical Clinic
state: California
city: Pasadena
country: United States
facility: Arroyo Seco Medical Group
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
state: California
city: San Diego
country: United States
facility: San Diego Endocrine and Medical Clinic
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: Santa Monica
country: United States
facility: Pacific Clinical Research
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: Denver
country: United States
facility: University of Colorado-Barbara Davis Center for Childhood Diabetes
state: Colorado
city: Waterbury
country: United States
facility: Pheonix International Medicine Associates
state: Connecticut
city: Newark
country: United States
facility: Health Core at Health Care Center Christiana
state: Delaware
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: 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: Daytona Beach
country: United States
facility: Atlantic Institute of Clinical Research
state: Florida
city: Daytona Beach
country: United States
facility: Halifax Clinical Research Institute
state: Florida
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: Hollywood
country: United States
facility: South Florida Clinical Research Center
state: Florida
city: Jacksonville
country: United States
facility: Health Trials 3000
state: Florida
city: Jupiter
country: United States
facility: Jupiter Research Institute
state: Florida
city: Maitland
country: United States
facility: ICSL Clinical Studies
state: Florida
city: Miami
country: United States
facility: Baptist Diabetes Associates
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Orlando
country: United States
facility: VRG Research
state: Florida
city: Palm Harbor
country: United States
facility: Highland Lakes Medical Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Endocrine Associates
state: Florida
city: Tampa
country: United States
facility: Biostator / USF Diabetes Center
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group
state: Florida
city: Vero Beach
country: United States
facility: Diabetes and Endocrine Associates of the Treasure Co
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: Atlanta
country: United States
facility: ICSL-Clinical Studies
state: Georgia
city: Atlanta
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Columbus
country: United States
facility: Columbus Metabolic Foundation
state: Georgia
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: Honolulu
country: United States
facility: Radiant Research
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 Memorail 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: Libertyville
country: United States
facility: Lake Forest Internal Medicine
state: Illinois
city: Libertyville
country: United States
facility: Winchester Research Group
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Springfield
country: United States
facility: Springfield Diabetes and Endocrinology
state: Illinois
city: Fort Wayne
country: United States
facility: Medical Group of Fort Wayne
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Outpatient Clinical Research
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 Corporation
state: Indiana
city: Des Moines
country: United States
facility: Ramona Holiday Diabetes Center
state: Iowa
city: Iowa City
country: United States
facility: Diabetes Clinical Research and Programs
state: Iowa
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: 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: New Orleans Center for Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Bangor
country: United States
facility: Diabetes, Endocrine and Nutrition Center
state: Maine
city: Baltimore
country: United States
facility: VA Medical Center
state: Maryland
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: Ann Arbor
country: United States
facility: University of Michigan-Endocrinology and Metabolism
state: Michigan
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: Kalamazoo
country: United States
facility: Westside Family Medical Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic, Division of Endocrinology and Metabolism
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: St. Louis Center for Clinical Research
state: Missouri
city: St. Louis
country: United States
facility: Radiant Research
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: Omaha
country: United States
facility: Creighton Diabetes Center
state: Nebraska
city: Las Vegas
country: United States
facility: Lovelace Scientific Resources
state: Nevada
city: Las Vegas
country: United States
facility: ICSL
state: Nevada
city: Dover
country: United States
facility: Endocrinology and Diabetes Consultants, P.C.
state: New Hampshire
city: Jersey City
country: United States
facility: HIS Clinical Research
state: New Jersey
city: Moorestown
country: United States
facility: Radiant Research
state: New Jersey
city: Mt. Laurel
country: United States
facility: Matrix Research Institute
state: New Jersey
city: Passaic
country: United States
facility: New Jersey Physicians
state: New Jersey
city: South Plainfield
country: United States
facility: Anderson and Collins Clinical Research, Inc.
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources
state: New Mexico
city: Bronx
country: United States
facility: Albert Einstein College of Medicine of Yeshiva University
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate
state: New York
city: Brooklyn
country: United States
facility: Medical Network Services, P.C.
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: St. Lukes Roosevelt Hospital
state: New York
city: New York
country: United States
facility: Irving Diabetes Research Unit at Columbia University
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
state: Ohio
city: Mentor
country: United States
facility: University Mednet
state: Ohio
city: Mogadore
country: United States
facility: Comprehensive Research Services, Inc.
state: Ohio
city: Westlake
country: United States
facility: North Coast Institute of Diabetes and Endocrinology
state: Ohio
city: Clinton
country: United States
facility: Prime Care Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: COR Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: OU Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: nTouch Research Corporation
state: Oklahoma
city: Tulsa
country: United States
facility: Utica Park Clinic
state: Oklahoma
city: Medford
country: United States
facility: Americas Doctors
state: Oregon
city: Medford
country: United States
facility: Medford Medical Clinic
state: Oregon
city: Portland
country: United States
facility: Radiant Research
state: Oregon
city: Portland
country: United States
facility: Portland Diabetes and Endocrinology Center
state: Oregon
city: Portland
country: United States
facility: Pacific Coast Clinical Coordinators, Inc.
state: Oregon
city: Portland
country: United States
facility: Legacy Clinical Research
state: Oregon
city: Camp Hill
country: United States
facility: Physicians for Clinical Research
state: Pennsylvania
city: Horsham
country: United States
facility: Argus Research Laboratories
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: Sellersville
country: United States
facility: Elite Medical Research, Inc.
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: East Providence
country: United States
facility: ICSL-Providence
state: Rhode Island
city: Charleston
country: United States
facility: Radiant Research
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: Alcoa
country: United States
facility: Tennessee Valley Clinical Research Associates
state: Tennessee
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: Memphis
country: United States
facility: The Endocrine Clinic
state: Tennessee
city: Milan
country: United States
facility: Integrity Clinical Research
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: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrinology Research Center
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: Fort Worth
country: United States
facility: Lanier Education Research Network
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: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: McAllen
country: United States
facility: South Texas Applied Research
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
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: Norfolk
country: United States
facility: Clinical Research Center-Eastern Virginia Medical School
state: Virginia
city: Richmond
country: United States
facility: Drs. Wigand, Wasserman, and Associates
state: Virginia
city: Kirkland
country: United States
facility: Evergreen Diabetes & Endocrinology
state: Washington
city: Lacey
country: United States
facility: Olympic Medical Services
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
city: Madison
country: United States
facility: University of Wisconsin West Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: Midwest Endocrinology Associates
state: Wisconsin
city: Milwaukee
country: United States
facility: VRG Research
state: Wisconsin
city: Calgary
country: Canada
facility: Calgary Metabolic Education and Research Center
state: Alberta
city: Edmonton
country: Canada
facility: Walter McKenzie Health Sciences Centre
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital, Research Services
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Center
state: Manitoba
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
city: Montreal
country: Canada
facility: McGill Nutrition and Food Science Center
state: Quebec
city: Ste. Foy
country: Canada
facility: Centre Hospitalier
state: Quebec
Study officials:
References: