A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)

March 19, 2015 updated by: AstraZeneca

A Randomized, Open-Label, Parallel-Group, Comparator-Controlled, Multicenter Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus

This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

254

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
      • Birmingham, Alabama, United States
        • Research Site
    • Arizona
      • Mesa, Arizona, United States
        • Research Site
      • Peoria, Arizona, United States
        • Research Site
    • California
      • Artesia, California, United States
        • Research Site
      • Concord, California, United States
        • Research Site
      • Encino, California, United States
        • Research Site
      • Greenbrae, California, United States
        • Research Site
      • La Mesa, California, United States
        • Research Site
      • Walnut Creek, California, United States
        • Research Site
    • Florida
      • DeLand, Florida, United States
        • Research Site
      • Hialeah, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • New Port Richey, Florida, United States
        • Research Site
      • Palm Harbor, Florida, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Indiana
      • Avon, Indiana, United States
        • Research Site
      • Evansville, Indiana, United States
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States
        • Research Site
      • Paducah, Kentucky, United States
        • Research Site
    • Michigan
      • Detroit, Michigan, United States
        • Research Site
    • Minnesota
      • Edina, Minnesota, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • Montana
      • Butte, Montana, United States
        • Research Site
    • New York
      • New Hyde Park, New York, United States
        • Research Site
      • Rochester, New York, United States
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States
        • Research Site
      • Statesville, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Delaware, Ohio, United States
        • Research Site
      • Mentor, Ohio, United States
        • Research Site
    • Oregon
      • Eugene, Oregon, United States
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Corpus Christi, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Virginia
      • Burke, Virginia, United States
        • Research Site
      • Manassas, Virginia, United States
        • Research Site
      • Richmond, Virginia, United States
        • Research Site
    • Washington
      • Olympia, Washington, United States
        • Research Site
      • Spokane, Washington, United States
        • Research Site
      • Tacoma, Washington, 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has been diagnosed with type 2 diabetes mellitus
  • Has hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at screening
  • Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening
  • Has been treated with diet and exercise alone or in combination with a stable regimen of metformin (MET), a sulfonylurea (SU), a thiazolidinedione (TZD), a combination of metformin and an SU, a combination of metformin and a TZD, or a combination of an SU and a TZD for a minimum of 2 months prior to screening

  • Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to screening:

    • Hormone replacement therapy (female subjects)
    • Oral contraceptives (female subjects)
    • Antihypertensive agents
    • Lipid-lowering agents
    • Thyroid replacement therapy
    • Antidepressant agents
    • Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over the counter antiobesity agents

Exclusion Criteria:

  • Has ever been exposed to exenatide (exenatide once weekly [exenatide LAR], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) analog
  • Has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening

  • Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:

    • Any dipeptidyl peptidase 4 (DPP-4) inhibitor within 3 months prior to screening
    • Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of screening
    • Insulin within 2 weeks of screening or for more than 1 week within 3 months of screening
    • Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: exenatide once weekly
subcutaneous injection, 2.0mg, once a week
Other Names:
  • BYDUREON
Active Comparator: 2
Drug: exenatide twice daily
subcutaneous injection; 5mcg (4 weeks) and 10mcg (20 weeks); twice a day
Other Names:
  • BYETTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 24
Time Frame: Day 1, Week 24
Change in HbA1c from baseline (Day 1) to Week 24 [Week 24 - Baseline].
Day 1, Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving HbA1c Target of <7%
Time Frame: Week 24
Percentages of subjects achieving HbA1c target value of <7% at Week 24.
Week 24
Percentage of Subjects Achieving HbA1c Target of <=6.5%
Time Frame: Week 24
Percentages of subjects achieving HbA1c target values of <=6.5% at Week 24.
Week 24
Change in Fasting Plasma Glucose From Baseline to Week 24
Time Frame: Day 1, Week 24
Change in fasting plasma glucose from baseline (Day 1) to Week 24.
Day 1, Week 24
Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL
Time Frame: Week 24
Percentages of subjects achieving fasting plasma glucose target of <=126 mg/dL at Week 24.
Week 24
Change in Body Weight From Baseline to Week 24
Time Frame: Day 1, Week 24
Change in body weight from baseline (Day 1) to Week 24.
Day 1, Week 24
Change in Sitting Systolic Blood Pressure From Baseline to Week 24
Time Frame: Day 1, Week 24
Change in systolic blood pressure from baseline (Day 1) to Week 24.
Day 1, Week 24
Change in Sitting Diastolic Blood Pressure From Baseline to Week 24
Time Frame: Day 1, Week 24
Change in diastolic blood pressure from baseline (Day 1) to Week 24.
Day 1, Week 24
Change in Total Cholesterol From Baseline to Week 24
Time Frame: Day 1, Week 24
Change in total cholesterol from baseline (Day 1) to Week 24.
Day 1, Week 24
Change in High-density Lipoprotein (HDL) From Baseline to Week 24
Time Frame: Day 1, Week 24
Change in HDL from baseline (Day 1) to Week 24.
Day 1, Week 24
Ratio of Triglycerides at Week 24 to Baseline
Time Frame: Day 1, Week 24
Ratio of triglycerides (measured in mg/dL) at Week 24 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
Day 1, Week 24
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
Time Frame: Day 1 to Week 24
The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject.
Day 1 to Week 24
Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events
Time Frame: Day 1 to Week 24
The minor hypoglycemia category included events in which symptoms consistent with hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.
Day 1 to Week 24

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

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

March 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

April 6, 2009

First Submitted That Met QC Criteria

April 7, 2009

First Posted (Estimate)

April 8, 2009

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCB108 (DURATION-5)

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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