Extension Study for 2993-112

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789957
• Other study ID #: 2993-112E
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2013
• Last updated: February 23, 2015
• Start date: September 2002
• Est. completion date: June 2004

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• AC2993
4-Week transition of AC2993 5 mcg subcutaneously injected twice daily followed by an open-ended period through study termination (up to 52 weeks) of AC2993 10 mcg subcutaneously injected twice daily

Locations

Country	Name	City	State
Canada	Calgary Metabolic Education and Research Center	Calgary	Alberta
Canada	Walter McKenzie Health Sciences Centre	Edmonton	Alberta
Canada	University of Western Ontario	London	Ontario
Canada	McGill Nutrition and Food Science Center	Montreal	Quebec
Canada	Centre Hospitalier	Ste. Foy	Quebec
Canada	St. Paul's Hospital, Research Services	Vancouver	British Columbia
Canada	Health Sciences Center	Winnipeg	Manitoba
United States	Lovelace Scientific Resources	Albuquerque	New Mexico
United States	Tennessee Valley Clinical Research Associates	Alcoa	Tennessee
United States	Advanced Clinical Research Institute	Anaheim	California
United States	University of Michigan-Endocrinology and Metabolism	Ann Arbor	Michigan
United States	Pinnacle Research Group	Anniston	Alabama
United States	Israel A. Hartman, M.D.	Arlington	Texas
United States	Medical Associates of Northern Virginia	Arlington	Virginia
United States	Endocrine Metabolic Medical Center	Atherton	California
United States	Clinical Research Atlanta	Atlanta	Georgia
United States	ICSL-Clinical Studies	Atlanta	Georgia
United States	Central Texas Clinical Research	Austin	Texas
United States	Mitchell Research Group, Inc.	Bakersfield	California
United States	St. Agnes Health Care	Baltimore	Maryland
United States	VA Medical Center	Baltimore	Maryland
United States	Diabetes, Endocrine and Nutrition Center	Bangor	Maine
United States	University Primary Care Center at Belvidere	Belvidere	Illinois
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Parkway Medical Center	Birmingham	Alabama
United States	Grunberger Diabetes Medical Center	Bloomfield Hills	Michigan
United States	Albert Einstein College of Medicine of Yeshiva University	Bronx	New York
United States	Medical Network Services, P.C.	Brooklyn	New York
United States	SUNY Downstate	Brooklyn	New York
United States	William Zigrang, M.D.	Burlingame	California
United States	Mercury Street Medical	Butte	Montana
United States	Physicians for Clinical Research	Camp Hill	Pennsylvania
United States	Mesa Center for Clinical Research	Chandler	Arizona
United States	CAMC Clinical Trials Center	Charleston	West Virginia
United States	Hyperion Clinical Research	Charleston	West Virginia
United States	Radiant Research	Charleston	South Carolina
United States	Charlotte Clinical Research	Charlotte	North Carolina
United States	Metrolina Medical Research	Charlotte	North Carolina
United States	CNS Clinical Trials	Chester	South Carolina
United States	Diabetes and Endocrinology Specialists	Chesterfield	Missouri
United States	Cook County Hospital	Chicago	Illinois
United States	Illinois Center for Clinical Trials	Chicago	Illinois
United States	Northwestern Memorail Physicians Group	Chicago	Illinois
United States	International Clinical Research Network	Chula Vista	California
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	Morton Plant Mease Health Care	Clearwater	Florida
United States	Rapid Medical Research	Cleveland	Ohio
United States	Prime Care Clinical Research	Clinton	Oklahoma
United States	Arrowhead Regional Medical Center	Colton	California
United States	Columbus Metabolic Foundation	Columbus	Georgia
United States	Ohio State University-Division of Endocrinology	Columbus	Ohio
United States	Radiant Research	Columbus	Ohio
United States	East Bay Clinical Trial Center	Concord	California
United States	Dallas Diabetes and Endocrinology Research Center	Dallas	Texas
United States	Rafael Canadas M.D., P.A.	Dallas	Texas
United States	Atlantic Institute of Clinical Research	Daytona Beach	Florida
United States	Halifax Clinical Research Institute	Daytona Beach	Florida
United States	nTouch Research Corporation	Decatur	Georgia
United States	University of Colorado-Barbara Davis Center for Childhood Diabetes	Denver	Colorado
United States	Ramona Holiday Diabetes Center	Des Moines	Iowa
United States	Henry Ford Health System	Detroit	Michigan
United States	Endocrinology and Diabetes Consultants, P.C.	Dover	New Hampshire
United States	UNC Diabetes Care Center	Durham	North Carolina
United States	ICSL-Providence	East Providence	Rhode Island
United States	Safe Harbor Clinical Research	East Providence	Rhode Island
United States	Eclectic Family Care	Eclectic	Alabama
United States	Internal Medicine Associates	El Paso	Texas
United States	Texas Tech University Health Sciences-Internal Medicine	El Paso	Texas
United States	Medical Group of Encino	Encino	California
United States	Medical Arts Research Collaborative	Excelsior Springs	Missouri
United States	First Care Family Doctors	Fayetteville	Arkansas
United States	Medical Group of Fort Wayne	Fort Wayne	Indiana
United States	Lanier Education Research Network	Fort Worth	Texas
United States	Mowry Clinical Research	Fremont	California
United States	SARC Research Center	Fresno	California
United States	Valley Research	Fresno	California
United States	Internal Medical Associates	Ft. Myers	Florida
United States	Clin Sci International	Gainesville	Florida
United States	University of FL	Gainesville	Florida
United States	Grand Rapids Associated Interns	Grand Rapids	Michigan
United States	Winston Physician Services	Haleyville	Alabama
United States	Unifour Medical Research	Hickory	North Carolina
United States	South Florida Clinical Research Center	Hollywood	Florida
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Radiant Research	Honolulu	Hawaii
United States	Argus Research Laboratories	Horsham	Pennsylvania
United States	Simon Williamson Clinic	Hueytown	Alabama
United States	American Health Network	Indianapolis	Indiana
United States	Center for Metabolic and Hormonal Disorders	Indianapolis	Indiana
United States	Indiana University Outpatient Clinical Research	Indianapolis	Indiana
United States	Diabetes Clinical Research and Programs	Iowa City	Iowa
United States	Irvine Clinical Research Center	Irvine	California
United States	North Texas Clinical Research	Irving	Texas
United States	Integrity Clinical Research	Jackson	Tennessee
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Health Trials 3000	Jacksonville	Florida
United States	HIS Clinical Research	Jersey City	New Jersey
United States	Harmony Clinical Research	Johnson City	Tennessee
United States	Jupiter Research Institute	Jupiter	Florida
United States	Westside Family Medical Center	Kalamazoo	Michigan
United States	Lipid, Atherosclerosis & Metabolic Clinic	Kansas City	Kansas
United States	St Lukes Lipid and Diabetes Research Center	Kansas City	Missouri
United States	Holston Medical Group	Kingsport	Tennessee
United States	Dr. Humberto Bruschetta	Kingsville	Texas
United States	Evergreen Diabetes & Endocrinology	Kirkland	Washington
United States	Endocrine Consultants of ET	Knoxville	Tennessee
United States	Whittier Institute for Diabetes	La Jolla	California
United States	Olympic Medical Services	Lacey	Washington
United States	R/D Clinical Research, Inc.	Lake Jackson	Texas
United States	Doctors Research Associates of Maryland	Lanham	Maryland
United States	ICSL	Las Vegas	Nevada
United States	Lovelace Scientific Resources	Las Vegas	Nevada
United States	Central Kentucky Research Associates	Lexington	Kentucky
United States	Kentucky Diabetes Center	Lexington	Kentucky
United States	University of Kentucky Metabolic Research Group	Lexington	Kentucky
United States	Lake Forest Internal Medicine	Libertyville	Illinois
United States	Winchester Research Group	Libertyville	Illinois
United States	CAVHS	Little Rock	Arkansas
United States	Physicians Group Research Clinic, LLC	Little Rock	Arkansas
United States	Harriman Jones Medical Group	Long Beach	California
United States	Richard Cherlin, M.D.	Los Gatos	California
United States	MedResearch, Inc.	Louisville	Kentucky
United States	University of Wisconsin West Clinic	Madison	Wisconsin
United States	ICSL Clinical Studies	Maitland	Florida
United States	South Texas Applied Research	McAllen	Texas
United States	Americas Doctors	Medford	Oregon
United States	Medford Medical Clinic	Medford	Oregon
United States	The Endocrine Clinic	Memphis	Tennessee
United States	University Mednet	Mentor	Ohio
United States	St. Luke's Family Health	Meridian	Idaho
United States	ANA Ventures, LLC	Mesa	Arizona
United States	Clinic of Physicians and Surgeons, Ltd.	Mesa	Arizona
United States	Drug Research Services	Metairie	Louisiana
United States	Baptist Diabetes Associates	Miami	Florida
United States	Integrity Clinical Research	Milan	Tennessee
United States	Midwest Endocrinology Associates	Milwaukee	Wisconsin
United States	VRG Research	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	Tushar Modi, M.D.	Modesto	California
United States	Comprehensive Research Services, Inc.	Mogadore	Ohio
United States	Extended Arm Physicians/ Southern Drug	Montgomery	Alabama
United States	Radiant Research	Moorestown	New Jersey
United States	Dr. Martinez Medical Clinic	Moreno Valley	California
United States	Matrix Research Institute	Mt. Laurel	New Jersey
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Mid State Endocrine Associates	Nashville	Tennessee
United States	New Orleans Center for Clinical Research	New Orleans	Louisiana
United States	New Orleans Institute of Clinical Investigation	New Orleans	Louisiana
United States	Ochsner Clinic	New Orleans	Louisiana
United States	Suncoast Clinical Research	New Port Richey	Florida
United States	Heights Medical Care	New York	New York
United States	Irving Diabetes Research Unit at Columbia University	New York	New York
United States	Naomi Berrie Diabetes Center at Columbia University	New York	New York
United States	St. Lukes Roosevelt Hospital	New York	New York
United States	Health Core at Health Care Center Christiana	Newark	Delaware
United States	Clinical Research Center-Eastern Virginia Medical School	Norfolk	Virginia
United States	COR Clinical Research	Oklahoma City	Oklahoma
United States	nTouch Research Corporation	Oklahoma City	Oklahoma
United States	OU Health Sciences Center	Oklahoma City	Oklahoma
United States	West Olympia Internal Medicine	Olympia	Washington
United States	Creighton Diabetes Center	Omaha	Nebraska
United States	VRG Research	Orlando	Florida
United States	Highland Lakes Medical Center	Palm Harbor	Florida
United States	Arroyo Seco Medical Group	Pasadena	California
United States	New Jersey Physicians	Passaic	New Jersey
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Philadelphia Health Associates	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Diabetes Research Center	Philadelphia	Pennsylvania
United States	Lovelace Scientific Resources	Phoenix	Arizona
United States	Physicians at the Peak	Phoenix	Arizona
United States	Legacy Clinical Research	Portland	Oregon
United States	Pacific Coast Clinical Coordinators, Inc.	Portland	Oregon
United States	Portland Diabetes and Endocrinology Center	Portland	Oregon
United States	Radiant Research	Portland	Oregon
United States	Elke Jost-Vu, M.D.	Rancho Mirage	California
United States	Comprehensive Diabetes-Endocrine Medical Associates	Redwood City	California
United States	Rainier Clinical Research Center	Renton	Washington
United States	Drs. Wigand, Wasserman, and Associates	Richmond	Virginia
United States	Mayo Clinic, Division of Endocrinology and Metabolism	Rochester	Minnesota
United States	Rochester Clinical Research	Rochester	New York
United States	Mid Missouri Research Specialists, Inc.	Rolla	Missouri
United States	Salt Lake Research	Salt Lake City	Utah
United States	Utah Diabetes Center at the University of Utah	Salt Lake City	Utah
United States	Diabetes and Glandular Disease Clinic	San Antonio	Texas
United States	SAM Clinical Research	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	University of Texas Health Sciences Center-Texas Diabetes Institute	San Antonio	Texas
United States	nTouch	San Diego	California
United States	Radiant Research	San Diego	California
United States	San Diego Endocrine and Medical Clinic	San Diego	California
United States	Veterans Medical Research Foundation	San Diego	California
United States	Diabetes Research Institute of Mills Peninsula	San Mateo	California
United States	Advanced Clinical Research Institute	Santa Ana	California
United States	Pacific Clinical Research	Santa Monica	California
United States	Elite Medical Research, Inc.	Sellersville	Pennsylvania
United States	West Coast Clinical Trials	Signal Hill	California
United States	nTouch Research Corporation	South Bend	Indiana
United States	Anderson and Collins Clinical Research, Inc.	South Plainfield	New Jersey
United States	Julia M. Hutchinson, M.D.	Spokane	Washington
United States	Northside Internal Medicine	Spokane	Washington
United States	Rockwood Clinic	Spokane	Washington
United States	Springfield Clinic	Springfield	Illinois
United States	Springfield Diabetes and Endocrinology	Springfield	Illinois
United States	Radiant Research	St. Louis	Missouri
United States	St. Louis Center for Clinical Research	St. Louis	Missouri
United States	Midwest Pharmaceutical Research	St. Peters	Missouri
United States	Tallahassee Endocrine Associates	Tallahassee	Florida
United States	Southern Drug Research Network	Tallassee	Alabama
United States	Biostator / USF Diabetes Center	Tampa	Florida
United States	Tampa Medical Group	Tampa	Florida
United States	Tipton Medical and Diagnostic Center	Tipton	Pennsylvania
United States	Advanced Clinical Therapeutics	Tucson	Arizona
United States	Utica Park Clinic	Tulsa	Oklahoma
United States	Diabetes and Endocrine Associates of the Treasure Co	Vero Beach	Florida
United States	Protocare Trials at Sharp Mission Park	Vista	California
United States	Diablo Clinical Research	Walnut Creek	California
United States	George Washington University	Washington	District of Columbia
United States	Medstar Clinical Research	Washington	District of Columbia
United States	Pheonix International Medicine Associates	Waterbury	Connecticut
United States	Wenatchee Valley Clinic	Wenatchee	Washington
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida
United States	Radiant Research	West Palm Beach	Florida
United States	North Coast Institute of Diabetes and Endocrinology	Westlake	Ohio
United States	New Hanover Medical Research Associates	Wilmington	North Carolina
United States	Piedmont Medical Research	Winston-Salem	North Carolina
United States	DOCS at Beth Israel Medical Center	Yonkers	New York

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from Day 1 of Protocol 2993-112 to Week 52 (or termination)	Change in HbA1c from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively.	Day 1 of study 2993-112 through extension study termination (up to Week 52)	No
Primary	Change in body weight from Day 1 of Protocol 2993-112 to Week 52 (or termination)	Change in body weight (KG) from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively.	Day 1 of study 2993-112 through extension study termination (up to Week 52)	No