Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus (DURATION-NEO-2)

July 31, 2015 updated by: AstraZeneca

A Randomized, Long-Term, Open-Label, 3-Arm, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo 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 sitagliptin or placebo administered once daily for 28 weeks in subjects with type 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

365

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, 35216
        • Research Site
      • Huntsville, Alabama, United States, 35801
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Research Site
      • Phoenix, Arizona, United States, 85020
        • Research Site
    • California
      • Beverly Hills, California, United States, 90036
        • Research Site
      • Buena Park, California, United States, 90620
        • Research Site
      • Chino, California, United States, 91710
        • Research Site
      • Chula Vista, California, United States, 91910
        • Research Site
      • Encinitas, California, United States, 92024
        • Research Site
      • Greenbrae, California, United States, 94904
        • Research Site
      • Los Angeles, California, United States, 90057
        • Research Site
      • Los Angeles, California, United States, 90059
        • Research Site
      • North Hollywood, California, United States, 91606
        • Research Site
      • Walnut Creek, California, United States, 94598
        • Research Site
      • West Hills, California, United States, 91307
        • Research Site
    • Florida
      • Boca Raton, Florida, United States, 33432
        • Research Site
      • Hialeah, Florida, United States, 33012
        • Research Site
      • Miami, Florida, United States, 33169
        • Research Site
      • Miami, Florida, United States, 33143
        • Research Site
      • Miami, Florida, United States, 33183
        • Research Site
      • Port Orange, Florida, United States, 32127
        • Research Site
      • St. Petersburg, Florida, United States, 33709
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Research Site
      • Evanston, Illinois, United States, 60201
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Research Site
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Research Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Research Site
      • Las Vegas, Nevada, United States, 89123
        • Research Site
      • Las Vegas, Nevada, United States, 89101
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Research Site
    • New York
      • Buffalo, New York, United States, 14215
        • Research Site
      • Hartsdale, New York, United States, 10530
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Research Site
      • Clayton, North Carolina, United States, 27520
        • Research Site
      • Durham, North Carolina, United States, 27710
        • Research Site
      • Greensboro, North Carolina, United States, 27410
        • Research Site
      • Mooresville, North Carolina, United States, 28117
        • Research Site
      • Salisbury, North Carolina, United States, 28144
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • Research Site
      • Franklin, Ohio, United States, 45005
        • Research Site
      • Marion, Ohio, United States, 43302
        • Research Site
    • Oklahoma
      • Yukon, Oklahoma, United States, 73099
        • Research Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Research Site
      • Portland, Oregon, United States, 97210
        • Research Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Research Site
      • Simpsonville, South Carolina, United States, 29681
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Reseach Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Research Site
    • Texas
      • Carrolton, Texas, United States, 75007
        • Research Site
      • Corpus Christi, Texas, United States, 78404
        • Research Site
      • Dallas, Texas, United States, 75390
        • Research Site
      • Houston, Texas, United States, 77074
        • Research Site
      • Houston, Texas, United States, 77072
        • Research Site
      • Katy, Texas, United States, 77450
        • Research Site
      • San Antonio, Texas, United States, 78205
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Research Site
      • Salt Lake City, Utah, United States, 84095
        • Research Site
    • Virginia
      • Burke, Virginia, United States, 22015
        • Research Site
    • Washington
      • 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 of 7.1% to 11.0%, inclusive, at screening
  • Has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening
  • Fasting plasma glucose concentration <280 mg/dL (15.5 mmol/L) at screening
  • Body mass index of <45 kg/m2 at screening
  • Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to Visit 1 (Screening)

Exclusion Criteria:

  • History of pancreatitis or triglycerides >=500 mg/dL
  • Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
  • History of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 mL/min
  • Active cardiovascular disease
  • Presence or history of severe congestive heart failure
  • Central nervous system disease, including epilepsy
  • Liver disease
  • History of severe gastrointestinal diseases
  • Clinically significant malignant disease
  • Repeated severe hypoglycemia within the last 6 months
  • Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog
  • Any DPP-4 inhibitor within 3 months prior 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exenatide once weekly suspension
Exenatide once weekly suspension 2mg subcutaneous injection
Drug: Exenatide once weekly suspension
Active Comparator: Sitagliptin 100mg
Overencapsulated Sitagliptin 100mg oral tablet once daily
Drug: Sitagliptin
Placebo Comparator: Placebo
Placebo oral capsule once daily
Drug: Placebo
Placebo oral capsule once daily

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
Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests.
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 target values of < 7.0% 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
The change in fasting plasma glucose concentrations from baseline (Day 1) 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
The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.
Baseline to Week 28
Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8)
Time Frame: Baseline to Week 16
The change in 2-hour postprandial plasma glucose from baseline (Day 1) to Visit 8 (Week 16) was analyzed using a general linear model including treatment, and baseline HbA1c stratum (< 9% or ≥ 9%) as fixed factors, and the baseline 2-hour postprandial plasma glucose concentrations as a covariate.
Baseline to Week 16

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Chair: Peter Ohman, 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

Helpful Links

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

February 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 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 (Estimate)

August 20, 2015

Last Update Submitted That Met QC Criteria

July 31, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCB120
  • MB001-004 (Other Identifier: 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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