Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.

December 5, 2016 updated by: AstraZeneca

A Randomized Double-blind, Parallel-group Study to Evaluate the Effect of BYDUREON Compared With Placebo on 24-hour Glucose Control in Metformin-treated Patients With Type 2 Diabetes

A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in 110 Metformin-treated Patients with Type 2 Diabetes

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Phase 4

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
    • California
      • Anaheim, California, United States
        • Research Site
      • Chino, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • North Hollywood, California, United States
        • Research Site
      • Santa Ana, California, United States
        • Research Site
      • Spring Valley, California, United States
        • Research Site
      • Tustin, California, United States
        • Research Site
      • Walnut Creek, California, United States
        • Research Site
    • Florida
      • Hollywood, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Port Orange, Florida, United States
        • Research Site
    • Georgia
      • Marietta, Georgia, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, 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
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • Ohio
      • Franklin, Ohio, United States
        • Research Site
      • Marion, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • South Carolina
      • Mt Pleasant, South Carolina, United States
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States
        • Research Site
    • Texas
      • Corpus Christi, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Katy, Texas, United States
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site
    • Virginia
      • Burke, Virginia, United States
        • Research Site
      • Manassas, Virginia, United States
        • Research Site
    • Washington
      • Olympia, 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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus (T2DM) treated with stable dose of metformin > or = to 1500mg/day as monotherapy for at least 8 weeks
  • Hemoglobin A1c (HbA1c) 7% to 10% at screening
  • Body mass index (BMI) < or = to 45 kg/m2

Exclusion Criteria:

  • History of taking antihyperglycemic therapy other than metformin or metformin extended release (XR) during the 8 weeks prior to screening
  • History of taking a dipeptidyl peptidase-4 (DPP-4) inhibitor or pramlintide during 12 weeks prior to screening
  • History of potent, inhaled or intrapulmonary steroids 3 months prior to screening or during the study
  • History of prescription or over the counter weight loss medication during 3 months prior to screening
  • Previous exposure to exenatide or any glucagon-like peptide-1 (GLP-1) receptor agonist during 6 months prior to 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo comparator
Drug: Placebo
Placebo
Experimental: Bydureon
Once weekly injected exenatide
Drug: Bydureon
Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks.
Other Names:
  • exenatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 24-hour Mean Weighted Glucose
Time Frame: Day 27/28
Change in 24-hour mean weighted glucose from baseline (Day -1/1) to Day 6 of Week 4 (Day 27/28) and to Day 6 of Week 10 (Day 69/70).
Day 27/28

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in 24-hour Mean Weighted Glucose Between Day 1 of Week 10 (Day 64/65) and Day 6 of Week 10 (Day 69/70) Within Each EQW-treated Patient
Time Frame: Day 64/65
Day 64/65
Change From Baseline (Day1) to Day 70 and Day 22 in FPG
Time Frame: Day 22/Day70
Day 22/Day70
Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)
Time Frame: Day 22 and Day 64
Day 22 and Day 64
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Time Frame: Week 4 and Week 10
Week 4 and Week 10
Change in HbA1c From Baseline to Day 22 and Baseline to Day 70
Time Frame: Day 22 and Day 70
Day 22 and Day 70

Collaborators and Investigators

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

Sponsor

AstraZeneca

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

December 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5551L00006

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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