Extension Study for 2993-112

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: AC2993

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 0M3
      • Calgary Metabolic Education and Research Center
    • Edmonton, Alberta, Canada, T6G 2B7
      • Walter McKenzie Health Sciences Centre
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital, Research Services
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Health Sciences Center
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • University of Western Ontario
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • McGill Nutrition and Food Science Center
    • Ste. Foy, Quebec, Canada, G1V 4G2
      • Centre Hospitalier
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group
    • Birmingham, Alabama, United States, 35206
      • Parkway Medical Center
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics
    • Eclectic, Alabama, United States, 36024
      • Eclectic Family Care
    • Haleyville, Alabama, United States, 35565
      • Winston Physician Services
    • Hueytown, Alabama, United States, 35023
      • Simon Williamson Clinic
    • Montgomery, Alabama, United States, 36106
      • Extended Arm Physicians/ Southern Drug
    • Tallassee, Alabama, United States, 36078
      • Southern Drug Research Network
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Mesa Center for Clinical Research
    • Mesa, Arizona, United States, 85201
      • Clinic of Physicians and Surgeons, Ltd.
    • Mesa, Arizona, United States, 85204
      • ANA Ventures, LLC
    • Phoenix, Arizona, United States, 85020
      • Physicians at the Peak
    • Phoenix, Arizona, United States, 85016
      • Lovelace Scientific Resources
    • Tucson, Arizona, United States, 85712
      • Advanced Clinical Therapeutics
  • Arkansas
    • Fayetteville, Arkansas, United States, 72701
      • First Care Family Doctors
    • Little Rock, Arkansas, United States, 72205
      • CAVHS
    • Little Rock, Arkansas, United States, 72205
      • Physicians Group Research Clinic, LLC
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
    • Atherton, California, United States, 94027
      • Endocrine Metabolic Medical Center
    • Bakersfield, California, United States, 93309
      • Mitchell Research Group, Inc.
    • Burlingame, California, United States, 94010
      • William Zigrang, M.D.
    • Chula Vista, California, United States, 91910
      • International Clinical Research Network
    • Colton, California, United States, 92324
      • Arrowhead Regional Medical Center
    • Concord, California, United States, 94520
      • East Bay Clinical Trial Center
    • Encino, California, United States, 91436
      • Medical Group of Encino
    • Fremont, California, United States, 94538
      • Mowry Clinical Research
    • Fresno, California, United States, 93720
      • Valley Research
    • Fresno, California, United States, 93720-2955
      • SARC Research Center
    • Irvine, California, United States, 92618
      • Irvine Clinical Research Center
    • La Jolla, California, United States, 92037
      • Whittier Institute for Diabetes
    • Long Beach, California, United States, 90806
      • Harriman Jones Medical Group
    • Los Gatos, California, United States, 95032
      • Richard Cherlin, M.D.
    • Modesto, California, United States, 95350
      • Tushar Modi, M.D.
    • Moreno Valley, California, United States, 92553
      • Dr. Martinez Medical Clinic
    • Pasadena, California, United States, 91105
      • Arroyo Seco Medical Group
    • Rancho Mirage, California, United States, 92270
      • Elke Jost-Vu, M.D.
    • Redwood City, California, United States, 94062
      • Comprehensive Diabetes-Endocrine Medical Associates
    • San Diego, California, United States, 92103
      • nTouch
    • San Diego, California, United States, 92161
      • Veterans Medical Research Foundation
    • San Diego, California, United States, 92108
      • Radiant Research
    • San Diego, California, United States, 92108
      • San Diego Endocrine and Medical Clinic
    • San Mateo, California, United States, 94401
      • Diabetes Research Institute of Mills Peninsula
    • Santa Ana, California, United States, 92701
      • Advanced Clinical Research Institute
    • Santa Monica, California, United States, 90404
      • Pacific Clinical Research
    • Signal Hill, California, United States, 90755
      • West Coast Clinical Trials
    • Vista, California, United States, 92083
      • Protocare Trials at Sharp Mission Park
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Colorado
    • Denver, Colorado, United States, 80262
      • University of Colorado-Barbara Davis Center for Childhood Diabetes
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Pheonix International Medicine Associates
  • Delaware
    • Newark, Delaware, United States, 19713
      • Health Core at Health Care Center Christiana
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University
    • Washington, District of Columbia, United States, 20003-4393
      • MedStar Clinical Research
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc.
    • Clearwater, Florida, United States, 33756
      • Morton Plant Mease Health Care
    • Daytona Beach, Florida, United States, 32114
      • Atlantic Institute of Clinical Research
    • Daytona Beach, Florida, United States, 32114
      • Halifax Clinical Research Institute
    • Ft. Myers, Florida, United States, 33901
      • Internal Medical Associates
    • Gainesville, Florida, United States, 32605
      • Clin Sci International
    • Gainesville, Florida, United States, 32610-0226
      • University of FL
    • Hollywood, Florida, United States, 33023
      • South Florida Clinical Research Center
    • Jacksonville, Florida, United States, 32250
      • Health Trials 3000
    • Jupiter, Florida, United States, 33458
      • Jupiter Research Institute
    • Maitland, Florida, United States, 32751
      • ICSL Clinical Studies
    • Miami, Florida, United States, 33176
      • Baptist Diabetes Associates
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research
    • Orlando, Florida, United States, 32801
      • VRG Research
    • Palm Harbor, Florida, United States, 34684
      • Highland Lakes Medical Center
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Endocrine Associates
    • Tampa, Florida, United States, 33614
      • Tampa Medical Group
    • Tampa, Florida, United States, 33612
      • Biostator / USF Diabetes Center
    • Vero Beach, Florida, United States, 32967
      • Diabetes and Endocrine Associates of the Treasure Co
    • West Palm Beach, Florida, United States, 33407
      • Radiant Research
    • West Palm Beach, Florida, United States, 33401
      • Metabolic Research Institute, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Clinical Research Atlanta
    • Atlanta, Georgia, United States, 30328
      • ICSL-Clinical Studies
    • Columbus, Georgia, United States, 31901
      • Columbus Metabolic Foundation
    • Decatur, Georgia, United States, 30033
      • nTouch Research Corporation
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • East-West Medical Research Institute
    • Honolulu, Hawaii, United States, 96814
      • Radiant Research
  • Idaho
    • Meridian, Idaho, United States, 83642
      • St. Luke's Family Health
  • Illinois
    • Belvidere, Illinois, United States, 61008
      • University Primary Care Center at Belvidere
    • Chicago, Illinois, United States, 60612
      • Cook County Hospital
    • Chicago, Illinois, United States, 60610
      • Illinois Center for Clinical Trials
    • Chicago, Illinois, United States, 60602
      • Northwestern Memorail Physicians Group
    • Libertyville, Illinois, United States, 60048
      • Lake Forest Internal Medicine
    • Libertyville, Illinois, United States, 60048
      • Winchester Research Group
    • Springfield, Illinois, United States, 62703
      • Springfield Clinic
    • Springfield, Illinois, United States, 62704
      • Springfield Diabetes and Endocrinology
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Medical Group of Fort Wayne
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Outpatient Clinical Research
    • Indianapolis, Indiana, United States, 46222
      • American Health Network
    • Indianapolis, Indiana, United States, 46260
      • Center for Metabolic and Hormonal Disorders
    • South Bend, Indiana, United States, 46601
      • nTouch Research Corporation
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Ramona Holiday Diabetes Center
    • Iowa City, Iowa, United States, 52242-1009
      • Diabetes Clinical Research and Programs
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Lipid, Atherosclerosis & Metabolic Clinic
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Central Kentucky Research Associates
    • Lexington, Kentucky, United States, 40503
      • Kentucky Diabetes Center
    • Lexington, Kentucky, United States, 40536-9841
      • University of Kentucky Metabolic Research Group
    • Louisville, Kentucky, United States, 40223
      • MedResearch, Inc.
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Drug Research Services
    • New Orleans, Louisiana, United States, 70119
      • New Orleans Center for Clinical Research
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic
    • New Orleans, Louisiana, United States, 70112
      • New Orleans Institute of Clinical Investigation
  • Maine
    • Bangor, Maine, United States, 04401
      • Diabetes, Endocrine and Nutrition Center
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • St. Agnes Health Care
    • Baltimore, Maryland, United States, 21201
      • VA Medical Center
    • Lanham, Maryland, United States, 20706
      • Doctors Research Associates of Maryland
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan-Endocrinology and Metabolism
    • Bloomfield Hills, Michigan, United States, 48302
      • Grunberger Diabetes Medical Center
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Grand Rapids, Michigan, United States, 49506
      • Grand Rapids Associated Interns
    • Kalamazoo, Michigan, United States, 49009
      • Westside Family Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic, Division of Endocrinology and Metabolism
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Diabetes and Endocrinology Specialists
    • Excelsior Springs, Missouri, United States, 64024
      • Medical Arts Research Collaborative
    • Kansas City, Missouri, United States, 64111
      • St Lukes Lipid and Diabetes Research Center
    • Rolla, Missouri, United States, 65401
      • Mid Missouri Research Specialists, Inc.
    • St. Louis, Missouri, United States, 63128
      • St. Louis Center for Clinical Research
    • St. Louis, Missouri, United States, 63141
      • Radiant Research
    • St. Peters, Missouri, United States, 63376
      • Midwest Pharmaceutical Research
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury Street Medical
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Creighton Diabetes Center
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Lovelace Scientific Resources
    • Las Vegas, Nevada, United States, 89106
      • ICSL
  • New Hampshire
    • Dover, New Hampshire, United States, 03820
      • Endocrinology and Diabetes Consultants, P.C.
  • New Jersey
    • Jersey City, New Jersey, United States, 07306
      • HIS Clinical Research
    • Moorestown, New Jersey, United States, 08057
      • Radiant Research
    • Mt. Laurel, New Jersey, United States, 08054
      • Matrix Research Institute
    • Passaic, New Jersey, United States, 07055
      • New Jersey Physicians
    • South Plainfield, New Jersey, United States, 07080
      • Anderson and Collins Clinical Research, Inc.
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Lovelace Scientific Resources
  • New York
    • Bronx, New York, United States, 10467
      • Albert Einstein College of Medicine of Yeshiva University
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate
    • Brooklyn, New York, United States, 11230
      • Medical Network Services, P.C.
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
    • New York, New York, United States, 10025
      • St. Lukes Roosevelt Hospital
    • New York, New York, United States, 10032
      • Naomi Berrie Diabetes Center at Columbia University
    • New York, New York, United States, 10033
      • Heights Medical Care
    • New York, New York, United States, 10032
      • Irving Diabetes Research Unit at Columbia University
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research
    • Yonkers, New York, United States, 10710
      • DOCS at Beth Israel Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • Metrolina Medical Research
    • Charlotte, North Carolina, United States, 28211
      • Charlotte Clinical Research
    • Durham, North Carolina, United States, 27713
      • UNC Diabetes Care Center
    • Hickory, North Carolina, United States, 28601
      • Unifour Medical Research
    • Wilmington, North Carolina, United States, 28412
      • New Hanover Medical Research Associates
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont Medical Research
  • Ohio
    • Cleveland, Ohio, United States, 44124
      • Rapid Medical Research
    • Columbus, Ohio, United States, 43212
      • Radiant Research
    • Columbus, Ohio, United States, 43210
      • Ohio State University-Division of Endocrinology
    • Mentor, Ohio, United States, 44060
      • University Mednet
    • Mogadore, Ohio, United States, 44260
      • Comprehensive Research Services, Inc.
    • Westlake, Ohio, United States, 44145
      • North Coast Institute of Diabetes and Endocrinology
  • Oklahoma
    • Clinton, Oklahoma, United States, 73601
      • Prime Care Clinical Research
    • Oklahoma City, Oklahoma, United States, 73104
      • OU Health Sciences Center
    • Oklahoma City, Oklahoma, United States, 73103
      • COR Clinical Research
    • Oklahoma City, Oklahoma, United States, 73112
      • nTouch Research Corporation
    • Tulsa, Oklahoma, United States, 74104
      • Utica Park Clinic
  • Oregon
    • Medford, Oregon, United States, 97504
      • Medford Medical Clinic
    • Medford, Oregon, United States, 97504
      • Americas Doctors
    • Portland, Oregon, United States, 97232
      • Legacy Clinical Research
    • Portland, Oregon, United States, 97201
      • Radiant Research
    • Portland, Oregon, United States, 97210
      • Portland Diabetes and Endocrinology Center
    • Portland, Oregon, United States, 97214
      • Pacific Coast Clinical Coordinators, Inc.
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Physicians for Clinical Research
    • Horsham, Pennsylvania, United States, 19044-12297
      • Argus Research Laboratories
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Diabetes Research Center
    • Philadelphia, Pennsylvania, United States, 19146
      • Philadelphia Health Associates
    • Sellersville, Pennsylvania, United States, 18960
      • Elite Medical Research, Inc.
    • Tipton, Pennsylvania, United States, 16684
      • Tipton Medical and Diagnostic Center
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Safe Harbor Clinical Research
    • East Providence, Rhode Island, United States, 02915
      • ICSL-Providence
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Radiant Research
    • Chester, South Carolina, United States, 29706
      • CNS Clinical Trials
    • Mt. Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • Tennessee
    • Alcoa, Tennessee, United States, 37701
      • Tennessee Valley Clinical Research Associates
    • Jackson, Tennessee, United States, 38305
      • Integrity Clinical Research
    • Johnson City, Tennessee, United States, 37601
      • Harmony Clinical Research
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
    • Knoxville, Tennessee, United States, 37909
      • Endocrine Consultants of ET
    • Memphis, Tennessee, United States, 38119
      • The Endocrine Clinic
    • Milan, Tennessee, United States, 38358
      • Integrity Clinical Research
    • Nashville, Tennessee, United States, 37203
      • Mid State Endocrine Associates
  • Texas
    • Arlington, Texas, United States, 76014
      • Israel A. Hartman, M.D.
    • Austin, Texas, United States, 78705
      • Central Texas Clinical Research
    • Dallas, Texas, United States, 75251
      • Rafael Canadas M.D., P.A.
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes and Endocrinology Research Center
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences-Internal Medicine
    • El Paso, Texas, United States, 79912
      • Internal Medicine Associates
    • Fort Worth, Texas, United States, 76107
      • Lanier Education Research Network
    • Irving, Texas, United States, 75038
      • North Texas Clinical Research
    • Kingsville, Texas, United States, 78363
      • Dr. Humberto Bruschetta
    • Lake Jackson, Texas, United States, 77566
      • R/D Clinical Research, Inc.
    • McAllen, Texas, United States, 78503
      • South Texas Applied Research
    • San Antonio, Texas, United States, 78207
      • University of Texas Health Sciences Center-Texas Diabetes Institute
    • San Antonio, Texas, United States, 78229-3894
      • Diabetes and Glandular Disease Clinic
    • San Antonio, Texas, United States, 78205
      • Sun Research Institute
    • San Antonio, Texas, United States, 78229
      • SAM Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Salt Lake Research
    • Salt Lake City, Utah, United States, 84108
      • Utah Diabetes Center at the University of Utah
  • Virginia
    • Arlington, Virginia, United States, 22204
      • Medical Associates of Northern Virginia
    • Norfolk, Virginia, United States, 23507
      • Clinical Research Center-Eastern Virginia Medical School
    • Richmond, Virginia, United States, 23225
      • Drs. Wigand, Wasserman, and Associates
  • Washington
    • Kirkland, Washington, United States, 98034
      • Evergreen Diabetes & Endocrinology
    • Lacey, Washington, United States, 98516
      • Olympic Medical Services
    • Olympia, Washington, United States, 98502
      • West Olympia Internal Medicine
    • Renton, Washington, United States, 98055
      • Rainier Clinical Research Center
    • Spokane, Washington, United States, 99202
      • Rockwood Clinic
    • Spokane, Washington, United States, 99201
      • Northside Internal Medicine
    • Spokane, Washington, United States, 99204
      • Julia M. Hutchinson, M.D.
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Clinic
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • CAMC Clinical Trials Center
    • Charleston, West Virginia, United States, 25301
      • Hyperion Clinical Research
  • Wisconsin
    • Madison, Wisconsin, United States, 53711
      • University of Wisconsin West Clinic
    • Milwaukee, Wisconsin, United States, 53215
      • Midwest Endocrinology Associates
    • Milwaukee, Wisconsin, United States, 53226
      • VRG Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open-label AC2993	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; Other Names: Exenatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Actual): June 1, 2004
• Study Completion (Actual): June 1, 2004

Study Registration Dates

• First Submitted: February 11, 2013
• First Submitted That Met QC Criteria: February 11, 2013
• First Posted (Estimate): February 12, 2013

Study Record Updates

• Last Update Posted (Estimate): February 24, 2015
• Last Update Submitted That Met QC Criteria: February 23, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Exenatide
• Other Study ID Numbers: 2993-112E