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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Amylin Pharmaceuticals, LLC.

ClinicalTrials.gov Identifier:

NCT00039013

First received: June 6, 2002

Last updated: February 4, 2013

Last verified: February 2013

History of Changes

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 medication (metformin) throughout the study.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	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 Two Times a Day in Subjects With Type 2 Diabetes Mellitus Treated With Metformin Alone

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Exenatide

U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, LLC.:

Primary Outcome Measures:

Change in HbA1c (glycosylated hemoglobin) from baseline to study termination (Week 30) [ Time Frame: Baseline (Day 1), Week 30 ] [ Designated as safety issue: No ]
Change in HbA1c from from baseline, measured from Visit 3 (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:	336
Study Start Date:	March 2002
Study Completion Date:	June 2003
Primary Completion Date:	June 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 / Placebo (0.02 mL) for 4 weeks / Placebo (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 metformin within a defined dose range 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 within 3 months of screening
Patients treated previously with AC2993
Patients presently treated with insulin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039013

Hide Study Locations

Locations

United States, Alabama
Pinnacle Research Group
Anniston, Alabama, United States, 36207
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Parkway Medical Center
Birmingham, Alabama, United States, 35206
Eclectic Family Care
Eclectic, Alabama, United States, 36024
Winston Physician Services
Haleyville, Alabama, United States, 35565
Simon Williamson Clinic
Hueytown, Alabama, United States, 35023
Extended Arm Physicians/ Southern Drug
Montgomery, Alabama, United States, 36106
Southern Drug Research Network
Tallassee, Alabama, United States, 36078
United States, Arizona
Clinic of Physicians and Surgeons, Ltd.
Mesa, Arizona, United States, 85201
ANA Ventures, LLC
Mesa, Arizona, United States, 85204
Physicians at the Peak
Phoenix, Arizona, United States, 85020
Lovelace Scientific Resources-Phoenix
Phoenix, Arizona, United States, 85016
Advanced Clinical Therapeutics
Tucson, Arizona, United States, 85712
United States, Arkansas
CAVHS
Little Rock, Arkansas, United States, 72205
Physicians Group Research Clinic, LLC
Little Rock, Arkansas, United States, 72205
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Mitchell Research Group, Inc.
Bakersfield, California, United States, 93309
William Zigrang, M.D.
Burlingame, California, United States, 94010
International Clinical Research Network
Chula Vista, California, United States, 91910
Arrowhead Regional Medical Center
Colton, California, United States, 92324
Valley Research
Fresno, California, United States, 93720
Elke Jost-Vu, M.D.
Rancho Mirage, California, United States, 92270
Comprehensive Diabetes-Endocrine Medical Associates
Redwood City, California, United States, 94062
Radiant Research-San Diego
San Diego, California, United States, 92108
nTouch
San Diego, California, United States, 92103
Veterans Medical Research Foundation
San Diego, California, United States, 92161
Diabetes Research Institute of Mills Peninsula
San Mateo, California, United States, 94401
Advanced Clinical Research Institute
Santa Ana, California, United States, 92701
West Coast Clinical Trials
Signal Hill, California, United States, 90755
Protocare Trials at Sharp Mission Park
Vista, California, United States, 92083
Diablo Clinical Research
Walnut Creek, California, United States, 94598
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
Internal Medical Associates
Ft. Myers, Florida, United States, 33901
Clin Sci International
Gainesville, Florida, United States, 32605
University of FL
Gainesville, Florida, United States, 32610-0226
Jupiter Research Institute
Jupiter, Florida, United States, 33458
Baptist Diabetes Associates
Miami, Florida, United States, 33176
Tampa Medical Group
Tampa, Florida, United States, 33614
Radiant Research
West Palm Beach, Florida, United States, 33407
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States, 33401
United States, Georgia
nTouch Research Corporation
Decatur, Georgia, United States, 30033
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96813
United States, Idaho
St. Luke's Family Health
Meridian, Idaho, United States, 83642
United States, Illinois
University Primary Care Center at Belvidere
Belvidere, Illinois, United States, 61008
Illinois Center for Clinical Trials
Chicago, Illinois, United States, 60610
Northwestern Memorial Physicians Group
Chicago, Illinois, United States, 60602
Winchester Research Group
Libertyville, Illinois, United States, 60048
Lake Forest Internal Medicine
Libertyville, Illinois, United States, 60048
United States, Indiana
Medical Group of Fort Wayne
Fort Wayne, Indiana, United States, 46804
American Health Network
Indianapolis, Indiana, United States, 46222
Center for Metabolic and Hormonal Disorders
Indianapolis, Indiana, United States, 46260
nTouch Research-South Bend
South Bend, Indiana, United States, 46601
United States, Kentucky
Kentucky Diabetes Center
Lexington, Kentucky, United States, 40503
University of Kentucky Metabolic Research Group
Lexington, Kentucky, United States, 40536-9841
MedResearch, Inc.
Louisville, Kentucky, United States, 40223
United States, Louisiana
Drug Research Services
Metairie, Louisiana, United States, 70001
New Orleans Institute of Clinical Investigation
New Orleans, Louisiana, United States, 70112
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maryland
St. Agnes Health Care
Baltimore, Maryland, United States, 21229
Doctors Research Associates of Maryland
Lanham, Maryland, United States, 20706
United States, Michigan
Grunberger Diabetes Medical Center
Bloomfield Hills, Michigan, United States, 48302
Henry Ford Health System
Detroit, Michigan, United States, 48202
Grand Rapids Associated Interns
Grand Rapids, Michigan, United States, 49506
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
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
United States, New Jersey
HIS Clinical Research
Jersey City, New Jersey, United States, 07306
Radiant Research-Moorestown
Moorestown, New Jersey, United States, 08057
New Jersey Physicians
Passaic, New Jersey, United States, 07055
United States, New Mexico
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87108
United States, New York
Medical Network Services, P.C.
Brooklyn, New York, United States, 11230
Heights Medical Care
New York, New York, United States, 10033
St. Lukes Roosevelt Hospital
New York, New York, United States, 10025
Naomi Berrie Diabetes Center at Columbia University
New York, New York, United States, 10032
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
Metrolina Medical Research
Charlotte, North Carolina, United States, 28209
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
Piedmont Medical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Rapid Medical Research
Cleveland, Ohio, United States, 44124
Ohio State University-Division of Endocrinology
Columbus, Ohio, United States, 43210
Radiant Research-Columbus
Columbus, Ohio, United States, 43212
University Mednet
Mentor, Ohio, United States, 44060
United States, Oklahoma
COR Clinical Research
Oklahoma City, Oklahoma, United States, 73103
nTouch Research Corporation-Oklahoma City
Oklahoma City, Oklahoma, United States, 73112
Utica Park Clinic
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Medford Medical Clinic
Medford, Oregon, United States, 97504
Legacy Clinical Research
Portland, Oregon, United States, 97232
Radiant Research
Portland, Oregon, United States
United States, Pennsylvania
Physicians for Clinical Research
Camp Hill, Pennsylvania, United States, 17011
Philadelphia Health Associates
Philadelphia, Pennsylvania, United States, 19146
Thomas Jefferson University Diabetes Research Center
Philadelphia, Pennsylvania, United States, 19107
Tipton Medical and Diagnostic Center
Tipton, Pennsylvania, United States, 16684
United States, Rhode Island
Safe Harbor Clinical Research
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Radiant Research-Charleston
Charleston, South Carolina, United States, 29407
CNS Clinical Trials
Chester, South Carolina, United States, 29706
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Integrity Clinical Research
Jackson, Tennessee, United States, 38305
Harmony Clinical Research
Johnson City, Tennessee, United States, 37601
Holston Medical Group
Kingsport, Tennessee, United States, 37660
Endocrine Consultants of ET
Knoxville, Tennessee, United States, 37909
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
Rafael Canadas M.D., P.A.
Dallas, Texas, United States, 75251
Internal Medicine Associates
El Paso, Texas, United States, 79912
Texas Tech University Health Sciences-Internal Medicine
El Paso, Texas, United States, 79905
North Texas Clinical Research
Irving, Texas, United States, 75038
Dr. Humberto Bruschetta
Kingsville, Texas, United States, 78363
South Texas Applied Research
McAllen, Texas, United States, 78503
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States, 78229-3894
SAM Clinical Research Center
San Antonio, Texas, United States
University of Texas Health Sciences Center-Texas Diabetes Institute
San Antonio, Texas, United States, 78207
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84124
United States, Washington
Evergreen Diabetes & Endocrinology
Kirkland, Washington, United States, 98034
West Olympia Internal Medicine
Olympia, Washington, United States, 98502
Rainier Clinical Research Center
Renton, Washington, United States, 98055
Julia M. Hutchinson, M.D.
Spokane, Washington, United States, 99204
Northside Internal Medicine
Spokane, Washington, United States, 99201
Rockwood Clinic
Spokane, Washington, United States, 99202
Wenatchee Valley Clinic
Wenatchee, Washington, United States, 98801
United States, West Virginia
CAMC Clinical Trials Center
Charleston, West Virginia, United States, 25304
Hyperion Clinical Research
Charleston, West Virginia, United States, 25301

Sponsors and Collaborators

Amylin Pharmaceuticals, LLC.

More Information

No publications provided by Amylin Pharmaceuticals, LLC.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:	NCT00039013 History of Changes
Other Study ID Numbers:	2993-112
Study First Received:	June 6, 2002
Last Updated:	February 4, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Exenatide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013

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