Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes (DURATION-NEO-1)

June 4, 2018 updated by: AstraZeneca

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

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.

To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

377

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
      • Muscle Shoals, Alabama, United States, 35662
        • Research Site
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Research Site
      • Phoenix, Arizona, United States, 85020
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Escondido, California, United States, 92026
        • Research Site
      • Garden Grove, California, United States, 92844
        • Research Site
      • Lomita, California, United States, 90717
        • Research Site
      • Los Angeles, California, United States, 90015
        • Research Site
      • Santa Ana, California, United States, 92705
        • Research Site
      • Spring Valley, California, United States, 91978
        • Research Site
      • Walnut Creek, California, United States, 94598
        • Research Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • Research Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Research Site
      • DeLand, Florida, United States, 32720
        • Research Site
      • Kissimmee, Florida, United States, 34741
        • Research Site
      • Miami, Florida, United States, 33156
        • Research Site
      • Orlando, Florida, United States, 32806
        • Research Site
      • Oviedo, Florida, United States, 32765
        • Research Site
      • Palm Harbor, Florida, United States, 34684
        • Research Site
      • Ponte Vedra, Florida, United States, 32081
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Research Site
      • Chicago, Illinois, United States, 60616
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Research Site
      • Paducah, Kentucky, United States, 42003
        • Research Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Research Site
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Research Site
      • Elkridge, Maryland, United States, 21075
        • Research Site
      • Hyattsville, Maryland, United States, 20782
        • Research Site
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Research Site
      • Troy, Michigan, United States, 48098
        • Research Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Research Site
    • Mississippi
      • Port Gibson, Mississippi, United States, 39150
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • Research Site
    • Montana
      • Butte, Montana, United States, 59701
        • Research Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Research Site
    • New York
      • Endwell, New York, United States, 13760
        • Research Site
      • New Windsor, New York, United States, 12553
        • Research Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Cincinnati, Ohio, United States, 45227
        • Research Site
      • Columbus, Ohio, United States, 43213
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73103
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Research Site
    • Pennsylvania
      • Harleysville, Pennsylvania, United States, 19438
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Research Site
      • Mount Pleasant, South Carolina, United States, 29464
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Research Site
      • Houston, Texas, United States, 77062
        • Research Site
      • San Antonio, Texas, United States, 78205
        • Research Site
    • Utah
      • Murray, Utah, United States, 84123
        • Research Site
      • Salt Lake City, Utah, United States, 84107
        • Research Site
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Research Site
      • Norfolk, Virginia, United States, 23502
        • Research Site
      • Richmond, Virginia, United States, 23294
        • Research Site
    • Washington
      • Olympia, Washington, United States, 98502
        • Research Site
      • Spokane, Washington, United States, 99202
        • 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:

  • At least 18 years old
  • Diagnosed with type 2 diabetes mellitus
  • HbA1c 7.1 to 11%, inclusive, at screening
  • Fasting plasma glucose <280 mg/dL (15.5 mmol/L)
  • Body mass index (BMI) <=45 kg/m2, inclusive, at screening
  • Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents

Exclusion Criteria:

  • History of pancreatitis or triglycerides >=500 mg/dL
  • Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
  • Active cardiovascular disease
  • Presence of congestive heart failure
  • Liver disease
  • History of severe gastrointestinal diseases
  • Repeated severe hypoglycemia within the last 6 months
  • Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog
  • Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exenatide once weekly suspension
Exenatide suspension 2 mg weekly subcutaneous injection
Drug: Exenatide once weekly suspension
Exenatide suspension 2 mg weekly subcutaneous injection
ACTIVE_COMPARATOR: Exenatide twice daily (BID)
Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
Drug: Exenatide twice daily
5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks
Other Names:
  • Byetta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28
Time Frame: Baseline to Week 28
The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.
Baseline to Week 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving HbA1c <7% at Week 28
Time Frame: Baseline to Week 28
Percentage of subjects achieving HbA1c <7% at Week 28/Study Termination
Baseline to Week 28
Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28
Time Frame: Baseline to Week 28
Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination
Baseline to Week 28
Change in Body Weight (kg) From Baseline to Week 28
Time Frame: Baseline to Week 28
Change in body weight (kg) from baseline to Week 28/Study Termination.
Baseline to Week 28
Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16
Time Frame: Baseline to Week 16
Change in 2-hour postprandial glucose concentrations from baseline to Week 16.
Baseline to Week 16

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Vice President Medical Research & Development, M.D., Amylin Pharmaceuticals, LLC.

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, 2013

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

July 26, 2012

First Submitted That Met QC Criteria

July 27, 2012

First Posted (ESTIMATE)

July 30, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 3, 2018

Last Update Submitted That Met QC Criteria

June 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCB118
  • MB001-003 (OTHER: Bristol Myers Squibb)

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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