A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)

March 19, 2015 updated by: AstraZeneca

A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release(Once Weekly) to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

514

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

  • India
      • Bangalore, India
        • Research Site
      • Indore, India
        • Research Site
      • Karnal, India
        • Research Site
      • Mumbai, India
        • Research Site
      • Pune, India
        • Research Site
  • Mexico
      • Toluca, Mexico
        • Research Site
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
      • Zapopan, Jalisco, Mexico
        • Research Site
    • Morelos
      • Cuernavaca, Morelos, Mexico
        • Research Site
    • NuevoLeon
      • Monterrey, NuevoLeon, Mexico
        • Research Site
  • United States
    • Arizona
      • 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
      • Orange, California, United States
        • Research Site
      • Walnut Creek, California, United States
        • Research Site
      • Whittier, California, United States
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Research Site
    • Florida
      • Coral Gables, Florida, United States
        • Research Site
      • Deland, Florida, United States
        • Research Site
      • Melbourne, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • New Port Richey, Florida, United States
        • Research Site
    • Georgia
      • Decatur, Georgia, United States
        • Research Site
    • Indiana
      • Avon, Indiana, United States
        • Research Site
    • Kansas
      • Wichita, Kansas, United States
        • Research Site
    • Kentucky
      • Paducah, Kentucky, United States
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Research Site
      • New Orleans, Louisiana, United States
        • Research Site
    • Maryland
      • Oxon Hill, Maryland, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
    • Michigan
      • Chelsea, Michigan, United States
        • Research Site
      • Ypsilanti, Michigan, United States
        • Research Site
    • Minnesota
      • St. Louis Park, Minnesota, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • Montana
      • Butte, Montana, United States
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • New York
      • New Hyde Park, New York, United States
        • Research Site
      • New Windsor, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
      • Rochester, New York, United States
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States
        • Research Site
      • Statesville, North Carolina, United States
        • Research Site
      • Winston-Salem, North Carolina, United States
        • Research Site
    • Ohio
      • Athens, Ohio, United States
        • Research Site
      • Cincinnati, Ohio, United States
        • Research Site
      • Dayton, Ohio, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Virginia
      • 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 a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start
  • Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
  • Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start

  • 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 study start:

    1. Hormone replacement therapy (female subjects)
    2. Oral contraceptives (female subjects)
    3. Antihypertensive agents
    4. Lipid-lowering agents
    5. Thyroid replacement therapy
    6. Antidepressant agents
    7. 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 been previously exposed to exenatide once weekly
  • Has donated blood within 60 days of study start or is planning to donate blood during the study

  • Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:

    1. Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3 months prior to study start
    2. Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start
    3. Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start
    4. 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
    5. Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®) and rifampin
  • Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
  • Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use

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: 1
Drug: exenatide once weekly
subcutaneous injection, 2.0mg, once a week
Drug: placebo tablet
oral tablet, once a day
Active Comparator: 2
Drug: sitagliptin
oral tablet, 100mg, once a day
Other Names:
  • Januvia
Drug: placebo once weekly
subcutaneous injection, once a week
Active Comparator: 3
Drug: placebo once weekly
subcutaneous injection, once a week
Drug: pioglitazone
oral tablet, 45mg, once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 26
Time Frame: Day 1, Week 26
Absolute change in HbA1c from baseline (Day 1) to Week 26 [Week 26 - Baseline].
Day 1, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving HbA1c Target of <7% at Week 26
Time Frame: Week 26
Percentages of subjects achieving HbA1c target values of <7% at Week 26.
Week 26
Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26
Time Frame: Week 26
Percentages of subjects achieving HbA1c target values of <=6.5% at Week 26.
Week 26
Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26
Time Frame: Week 26
Percentages of subjects achieving HbA1c target values of <=6.0% at Week 26.
Week 26
Change in Body Weight From Baseline to Week 26
Time Frame: Day 1, Week 26
Change in body weight from baseline (Day 1) to Week 26.
Day 1, Week 26
Change in Fasting Plasma Glucose From Baseline to Week 26
Time Frame: Day 1, Week 26
Change in fasting plasma glucose from baseline (Day 1) to Week 26.
Day 1, Week 26
Change in Systolic Blood Pressure From Baseline to Week 26
Time Frame: Day 1, Week 26
Change in systolic blood pressure from baseline (Day 1) to Week 26.
Day 1, Week 26
Change in Diastolic Blood Pressure From Baseline to Week 26
Time Frame: Day 1, Week 26
Change in diastolic blood pressure from baseline (Day 1) to Week 26.
Day 1, Week 26
Change in Fasting Total Cholesterol From Baseline to Week 26
Time Frame: Day 1, Week 26
Change in fasting total cholesterol from baseline (Day 1) to Week 26.
Day 1, Week 26
Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26
Time Frame: Day 1, Week 26
Change in fasting HDL from baseline (Day 1) to Week 26.
Day 1, Week 26
Ratio of Fasting Triglycerides at Week 26 to Baseline
Time Frame: Day 1, Week 26
Ratio of triglycerides (measured in mg/dL) at Week 26 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 26
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events
Time Frame: Day 1 to Week 26
Major hypoglycemia: 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 < 54 mg/dL prior to treatment. Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration < 54 mg/dL prior to treatment and not classified as major hypoglycemia.
Day 1 to Week 26

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

January 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

March 6, 2008

First Submitted That Met QC Criteria

March 10, 2008

First Posted (Estimate)

March 17, 2008

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

  • BCB106 (DURATION - 2)

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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