Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00035984
First received: May 7, 2002
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
Drug: AC2993
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in HbA1c from Baseline to Week 30 [ Time Frame: Baseline (Day 1) to Week 30 ] [ Designated as safety issue: No ]
    Change in HbA1c from Baseline (Day 1) to study termination (Week 30)


Secondary Outcome Measures:
  • Change in HbA1c from baseline (Day 1) to each of the intermediate visits [ Time Frame: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24 ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline, measured from Visit 3 (Day 1) to each of the intermediate visits (Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, and Week 24)

  • The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30 [ Time Frame: Baseline (Day 1) and Week 30 ] [ Designated as safety issue: No ]
    The number of subjects achieving HbA1c target values of < 7% and < 8% by study termination (Week 30)

  • The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30 [ Time Frame: Baseline (Day 1), and Week 30 ] [ Designated as safety issue: No ]
    The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by study termination (Week 30)

  • The time to achieve specific HbA1c target values of < 7% and < 8% [ Time Frame: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30 ] [ Designated as safety issue: No ]
    The time it takes subjects to achieve HbA1c target values of < 7% and < 8%

  • The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more [ Time Frame: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30 ] [ Designated as safety issue: No ]
    The time it takes subjects to achieve HbA1c reductions of 0.5% or more and >1.0% or more

  • Change in body weight from Baseline to each intermediate visit and Week 30 [ Time Frame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30 ] [ Designated as safety issue: No ]
    Change in body weight (kg) from Baseline to each intermediate visit and Week 30


Enrollment: 734
Study Start Date: May 2002
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AC2993 5 mcg (0.02 mL)
Placebo, then AC2993 5 mcg, then AC2993 5 mcg
Drug: AC2993
Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
Other Name: synthetic exendin-4
Experimental: AC2993 10mcg (0.04 mL)
Placebo, then AC2993 5 mcg, then AC2993 10 mcg
Drug: AC2993
Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5 mcg (0.02 mL) for 4 weeks / AC2993 10 mcg (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
Other Name: synthetic exendin-4
Placebo Comparator: Placebo 0.02 mL
Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL
Drug: Placebo
Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
Placebo Comparator: Placebo 0.04 mL
Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL
Drug: Placebo
Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035984

  Hide Study Locations
Locations
United States, Alabama
Pinnacle Research Group
Anniston, Alabama, United States, 36207
Parkway Medical Center
Birmingham, Alabama, United States, 35206
Extended Arm Physicians/ Southern Drug
Montgomery, Alabama, United States, 36106
Southern Drug Research Network
Tallassee, Alabama, United States, 36078
United States, Arkansas
First Care Family Doctors
Fayetteville, Arkansas, United States, 72701
Physicians Group Research Clinic, LLC
Little Rock, Arkansas, United States, 72205
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
East Bay Clinical Trial Center
Concord, California, United States
Medical Group of Encino
Encino, California, United States, 91436
Valley Research
Fresno, California, United States, 93720
St. Joseph Heritage Healthcare
Fullerton, California, United States, 92835
Whittier Institute for Diabetes
La Jolla, California, United States, 92037
Richard Cherlin, M.D.
Los Gatos, California, United States, 95032
Dr. Martinez Medical Clinic
Moreno Valley, California, United States, 92553
Comprehensive Diabetes-Endocrine Medical Associates
Redwood City, California, United States, 94062
Radiant Research-San Diego
San Diego, California, United States, 92108
Veterans Medical Research Foundation
San Diego, California, United States, 92161
Diablo Clinical Research
Walnut Creek, California, United States
United States, Colorado
Creekside Endocrine Associates
Denver, Colorado, United States, 80209
University of Colorado-Barbara Davis Center for Childhood Diabetes
Denver, Colorado, United States, 80262
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
Medstar Clinical Research
Washington, District of Columbia, United States, 20003-4393
United States, Florida
Medical Research Unlimited
Aventura, Florida, United States
Morton Plant Mease Health Care
Clearwater, Florida, United States, 33756
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
Internal Medicine Associates
Ft. Myers, Florida, United States
Clin Sci International
Gainesville, Florida, United States, 32605
Northeast Florida Endocrine & Diabetes Research
Jacksonville, Florida, United States, 32204
Jupiter Research Institute
Jupiter, Florida, United States, 33458
Baptist Diabetes Associates
Miami, Florida, United States, 33176
Comprehensive NeuroScience Inc.
Sarasota, Florida, United States, 34232
Tallahassee Endocrine Associates
Tallahassee, Florida, United States, 32308
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States, 33401
United States, Georgia
Columbus Metabolic Foundation
Columbus, Georgia, United States, 31901
United States, Hawaii
University of Hawaii-Diabetes Research Group
Ewa Beach, Hawaii, United States, 96706
United States, Illinois
University Primary Care Center at Belvidere
Belvidere, Illinois, United States, 61008
Northwestern Memorial Physicians Group
Chicago, Illinois, United States, 60602
Cook County Hospital
Chicago, Illinois, United States, 60612
Illinois Center for Clinical Trials
Chicago, Illinois, United States, 60610
United States, Indiana
Indiana University Outpatient Clinical Research
Indianapolis, Indiana, United States
American Health Network
Indianapolis, Indiana, United States, 46222
United States, Kansas
Lipid, Atherosclerosis & Metabolic Clinic
Kansas City, Kansas, United States, 66160
United States, Kentucky
Kentucky Diabetes Center
Lexington, Kentucky, United States, 40503
Central Kentucky Research Associates
Lexington, Kentucky, United States, 40509
University of Kentucky Metabolic Research Group
Lexington, Kentucky, United States, 40536-9841
MedResearch, Inc.
Louisville, Kentucky, United States, 40223
United States, Louisiana
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States, 70119
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maryland
University of Maryland-Joslin Diabetes Center
Baltimore, Maryland, United States, 21012
United States, Massachusetts
Clinica Research Inc.
Waltham, Massachusetts, United States, 02154
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States
Grand Rapids Associated Interns
Grand Rapids, Michigan, United States
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Diabetes and Endocrinology Specialists
Chesterfield, Missouri, United States, 63017
Medical Arts Research Collaborative
Excelsior Springs, Missouri, United States, 64024
St Lukes Lipid and Diabetes Research Center
Kansas City, Missouri, United States, 64111
Mid Missouri Research Specialists, Inc.
Rolla, Missouri, United States, 65401
Radiant Research-St. Louis
St. Louis, Missouri, United States, 63141
Midwest Pharmaceutical Research
St. Peters, Missouri, United States, 63376
United States, Montana
Mercury Street Medical
Butte, Montana, United States, 59701
United States, Nevada
Lovelace Scientific Resources-Las Vegas
Las Vegas, Nevada, United States, 89102
Lisa Abbott, MD
Reno, Nevada, United States, 89502
United States, New York
SUNY Downstate
Brooklyn, New York, United States, 11203
St. Lukes Roosevelt Hospital
New York, New York, United States, 10025
Rochester Clinical Research
Rochester, New York, United States, 14609
DOCS at Beth Israel Medical Center
Yonkers, New York, United States, 10710
United States, North Carolina
Charlotte Clinical Research
Charlotte, North Carolina, United States, 28211
UNC Diabetes Care Center
Durham, North Carolina, United States, 27713
Unifour Medical Research
Hickory, North Carolina, United States, 28601
New Hanover Medical Research Associates
Wilmington, North Carolina, United States, 28412
United States, Ohio
Radiant Research-Columbus
Columbus, Ohio, United States, 43212
University Mednet
Mentor, Ohio, United States, 44060
United States, Oklahoma
OU Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Medford Medical Clinic
Medford, Oregon, United States, 97504
Radiant Research
Portland, Oregon, United States
United States, Pennsylvania
Physicians for Clinical Research
Camp Hill, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Philadelphia Health Associates
Philadelphia, Pennsylvania, United States, 19146
Thomas Jefferson University Diabetes Research Center
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
CNS Clinical Trials
Chester, South Carolina, United States, 29706
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Holston Medical Group
Kingsport, Tennessee, United States, 37660
The Endocrine Clinic
Memphis, Tennessee, United States, 38119
Mid State Endocrine Associates
Nashville, Tennessee, United States, 37203
United States, Texas
Israel A. Hartman, M.D.
Arlington, Texas, United States, 76014
Dallas Diabetes and Endocrinology Research Center
Dallas, Texas, United States, 75230
Texas Tech University Health Sciences-Internal Medicine
El Paso, Texas, United States, 79905
North Texas Clinical Research
Irving, Texas, United States, 75038
University of Texas Health Sciences Center-Texas Diabetes Institute
San Antonio, Texas, United States, 78207
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States, 78229-3894
SAM Clinical Research
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84124
Utah Diabetes Center at the University of Utah
Salt Lake City, Utah, United States, 84108
United States, Virginia
Medical Associates of Northern Virginia
Arlington, Virginia, United States, 22204
United States, Washington
West Olympia Internal Medicine
Olympia, Washington, United States, 98502
Rockwood Clinic
Spokane, Washington, United States, 99202
United States, Wisconsin
University of Wisconsin West Clinic
Madison, Wisconsin, United States, 53711
Midwest Endocrinology Associates
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00035984     History of Changes
Other Study ID Numbers: 2993-115
Study First Received: May 7, 2002
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Type 2 Diabetes Mellitis

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014