Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

February 20, 2015 updated by: AstraZeneca
This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

182

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • Nova Scotia
      • Dartmouth, Nova Scotia, Canada
        • Research Site
    • Ontario
      • London, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
  • Spain
      • Granada, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Valladolid, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • California
      • La Jolla, California, United States
        • Research Site
      • San Mateo, California, United States
        • Research Site
      • Santa Barbara, California, United States
        • Research Site
      • Spring Valley, California, United States
        • Research Site
    • Florida
      • Hialeah, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Melbourne, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, United States
        • Research Site
      • Troy, Michigan, United States
        • Research Site
    • Montana
      • Butte, Montana, United States
        • Research Site
    • Nebraska
      • McCook, Nebraska, United States
        • Research Site
      • North Platte, Nebraska, United States
        • Research Site
      • Omaha, Nebraska, United States
        • Research Site
      • Scottsbluff, Nebraska, United States
        • Research Site
    • New Jersey
      • Princeton, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • Albany, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
      • Rochester, New York, United States
        • Research Site
    • North Carolina
      • Greenville, North Carolina, United States
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Research Site
      • Knoxville, Tennessee, United States
        • Research Site
    • Texas
      • Dallas, Texas, United States
        • Research Site
      • Georgetown, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
      • The Colony, Texas, United States
        • Research Site
    • Washington
      • Olympia, Washington, United States
        • Research Site
      • Renton, Washington, United States
        • Research Site
      • Tacoma, Washington, United States
        • Research Site
    • West Virginia
      • Charleston, West Virginia, United States
        • Research Site
      • Huntington, West Virginia, United States
        • Research Site

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

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.
  • HbA1c between 7.1% and 10.0%, inclusive.
  • Body mass index (BMI) between 25 kg/m^2 and 45 kg/m^2.

Exclusion Criteria:

  • Patient previously in a study using exenatide or GLP-1 analogs.
  • Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.
  • Treated with oral insulin within 3 months of screening.

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: Exenatide
After a 2-week placebo lead-in period, exenatide will be given in an esclating dose along with the subject's current therapy regimen
Drug: exenatide
After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer 20 mcg of exenatide (2 units [5 μg] ), twice daily by subcutaneous injection, for the first 4 weeks of therapy, and then 40 μL of study drug (4 units [10 μg] of exenatide) twice daily by subcutaneous injection, for the remaining 12 weeks of therapy.
Other Names:
  • Byetta
  • synthetic exendin-4
  • AC2993
Placebo Comparator: Placebo
After a 2-week placebo lead-in period, subjects will be given placebo (in equivalent amounts to exenatide) in addition to their current therapy regimen.
Drug: Placebo
After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer placebo (in equivalent amounts to exenatide) for 16 weeks of therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16, and if measured, any visits in between
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
Change in HbA1c from Baseline (Visit 3) to study termination at Week 16, and at all study visits in between
Baseline, Week 4, Week 8, Week 12, Week 16
Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose
Time Frame: Baseline, Week 16
Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)
Baseline, Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose
Time Frame: Baseline, Week 16
Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)
Baseline, Week 16
Percentage of subjects reaching the target HbA1c (<7%)
Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
The percentage of subjects reaching the target HbA1c (<7%) will be summarized and compared by treatment
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Change in body weight from Baseline to Week 16
Time Frame: Baseline, Week 16
Change in body weight (kg) from Baseline to Week 16
Baseline, Week 16
Changes in beta cell function and insulin sensitivity between Baseline and Week 16
Time Frame: Baseline, Week 16
Changes in beta cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses and the proinsulin/insulin ratio Between Baseline and Week 16
Baseline, Week 16
Changes in lipids between Baseline and Week 16
Time Frame: Baseline, Week 16
Changes from Baseline to Week 16 in serum lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL-C], fasting triglycerides, calculated low-density lipoprotein cholesterol [LDL-C]
Baseline, Week 16

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: James Malone, MD, Eli Lilly and Company

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

May 1, 2004

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

December 10, 2004

First Submitted That Met QC Criteria

December 10, 2004

First Posted (Estimate)

December 13, 2004

Study Record Updates

Last Update Posted (Estimate)

February 23, 2015

Last Update Submitted That Met QC Criteria

February 20, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H8O-MC-GWAP

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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