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

February 23, 2015 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

336

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
      • Mesa, Arizona, United States, 85201
        • Clinic of Physicians and Surgeons, Ltd.
      • Mesa, Arizona, United States, 85204
        • ANA Ventures, LLC
      • Phoenix, Arizona, United States, 85016
        • Lovelace Scientific Resources-Phoenix
      • Phoenix, Arizona, United States, 85020
        • Physicians at the Peak
      • Tucson, Arizona, United States, 85712
        • Advanced Clinical Therapeutics
    • Arkansas
      • 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
      • 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
      • Fresno, California, United States, 93720
        • Valley Research
      • 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, 92108
        • Radiant Research-San Diego
      • San Diego, California, United States, 92161
        • Veterans Medical Research Foundation
      • San Mateo, California, United States, 94401
        • Diabetes Research Institute of Mills Peninsula
      • Santa Ana, California, United States, 92701
        • Advanced Clinical Research Institute
      • 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
    • 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
      • 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
      • Jupiter, Florida, United States, 33458
        • Jupiter Research Institute
      • Miami, Florida, United States, 33176
        • Baptist Diabetes Associates
      • Tampa, Florida, United States, 33614
        • Tampa Medical Group
      • West Palm Beach, Florida, United States, 33407
        • Radiant Research
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute, Inc.
    • Georgia
      • Decatur, Georgia, United States, 30033
        • nTouch Research Corporation
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • East-West Medical Research Institute
    • 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, 60602
        • Northwestern Memorial Physicians Group
      • Chicago, Illinois, United States, 60610
        • Illinois Center for Clinical Trials
      • Libertyville, Illinois, United States, 60048
        • Lake Forest Internal Medicine
      • Libertyville, Illinois, United States, 60048
        • Winchester Research Group
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Medical Group of Fort Wayne
      • 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-South Bend
    • Kentucky
      • 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, 70121
        • Ochsner Clinic
      • New Orleans, Louisiana, United States, 70112
        • New Orleans Institute of Clinical Investigation
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • St. Agnes Health Care
      • Lanham, Maryland, United States, 20706
        • Doctors Research Associates of Maryland
    • Michigan
      • 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
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Diabetes and Endocrinology Specialists
      • Rolla, Missouri, United States, 65401
        • Mid Missouri Research Specialists, Inc.
      • St. Louis, Missouri, United States, 63141
        • Radiant Research-St. Louis
      • St. Peters, Missouri, United States, 63376
        • Midwest Pharmaceutical Research
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Lovelace Scientific Resources-Las Vegas
    • New Jersey
      • Jersey City, New Jersey, United States, 07306
        • HIS Clinical Research
      • Moorestown, New Jersey, United States, 08057
        • Radiant Research-Moorestown
      • Passaic, New Jersey, United States, 07055
        • New Jersey Physicians
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Lovelace Scientific Resources
    • New York
      • Brooklyn, New York, United States, 11230
        • Medical Network Services, P.C.
      • 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
      • 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, 43210
        • Ohio State University-Division of Endocrinology
      • Columbus, Ohio, United States, 43212
        • Radiant Research-Columbus
      • Mentor, Ohio, United States, 44060
        • University Mednet
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • COR Clinical Research
      • Oklahoma City, Oklahoma, United States, 73112
        • nTouch Research Corporation-Oklahoma City
      • Tulsa, Oklahoma, United States, 74104
        • Utica Park Clinic
    • Oregon
      • Medford, Oregon, United States, 97504
        • Medford Medical Clinic
      • Portland, Oregon, United States, 97232
        • Legacy Clinical Research
      • Portland, Oregon, United States
        • Radiant Research
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Physicians for Clinical Research
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Diabetes Research Center
      • Philadelphia, Pennsylvania, United States, 19146
        • Philadelphia Health Associates
      • Tipton, Pennsylvania, United States, 16684
        • Tipton Medical and Diagnostic Center
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Safe Harbor Clinical Research
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Radiant Research-Charleston
      • Chester, South Carolina, United States, 29706
        • CNS Clinical Trials
      • Mt. Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Tennessee
      • 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
    • Texas
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research
      • Dallas, Texas, United States, 75251
        • Rafael Canadas M.D., P.A.
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Sciences-Internal Medicine
      • El Paso, Texas, United States, 79912
        • Internal Medicine Associates
      • Irving, Texas, United States, 75038
        • North Texas Clinical Research
      • Kingsville, Texas, United States, 78363
        • Dr. Humberto Bruschetta
      • 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
        • Sam Clinical Research Center
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Salt Lake Research
    • Washington
      • Kirkland, Washington, United States, 98034
        • Evergreen Diabetes & Endocrinology
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • synthetic exendin-4
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 Names:
  • 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 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
Other Names:
  • synthetic exendin-4
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 Names:
  • 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
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
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 (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (glycosylated hemoglobin) from baseline to study termination (Week 30)
Time Frame: Baseline (Day 1), Week 30
Change in HbA1c from from baseline, measured from Visit 3 (Day 1) to study termination (Week 30).
Baseline (Day 1), Week 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30
Time Frame: Baseline (Day 1) and Week 30
The number of subjects achieving HbA1c target values of < 7% and < 8% by study termination (Week 30)
Baseline (Day 1) and 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
The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by study termination (Week 30)
Baseline (Day 1), and Week 30
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
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)
Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24
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
The time it takes subjects to achieve HbA1c target values of < 7% and < 8%
Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30
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
The time it takes subjects to achieve HbA1c reductions of 0.5% or more and >1.0% or more
Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30
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
Change in body weight (kg) from Baseline to each intermediate visit and Week 30
Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

June 6, 2002

First Submitted That Met QC Criteria

June 7, 2002

First Posted (Estimate)

June 10, 2002

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

Other Study ID Numbers

  • 2993-112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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