Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin

February 20, 2015 updated by: AstraZeneca
This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

466

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

  • China
      • Beijing, China
        • Research Site
      • Guangzhou, China
        • Research Site
      • Nanjing, China
        • Research Site
      • Shanghai, China
        • Research Site
      • Sichuan, China
        • Research Site
  • India
      • Chennai, India
        • Research Site
      • Mumbai, India
        • Research Site
      • Pune, India
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Research Site
      • Sungnam City, Korea, Republic of
        • Research Site
  • Taiwan
      • Chiayi, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • 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

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Treated with a stable dose of one of the following for at least 3 months prior to screening: * >=1000 mg/day immediate-release metformin; or metformin >=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy.
  • HbA1c between 7.1% and 11.0%, inclusive.
  • Body Mass Index (BMI) >21 kg/m^2 and <35 kg/m^2.

Exclusion Criteria:

  • Have participated in this study previously, or any other study using exenatide or GLP-1 analogs.
  • Have participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening.
  • Have characteristics contraindicating metformin or sulfonylurea use.
  • Have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening.
  • Have used drugs for weight loss within 1 month of 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exenatide
Placebo lead-in; exenatide 5 mcg for 4 weeks; exenatide 10 mcg for 12 weeks
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day for 16 weeks
Other Names:
  • Byetta
Placebo Comparator: Placebo
Placebo in volume equal to exenatide
Drug: Placebo
subcutaneous injection twice daily in volumes equal to exenatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To test the hypothesis that exenatide (before morning and evening meals) produces a greater decrease in HbA1c than placebo in patients with type 2 diabetes and inadequate glycemic control taking metformin alone or metformin and sulfonylureas.
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare exenatide and placebo groups with respect to: *safety and tolerability; *proportion of patients achieving HbA1c<=7%; *body weight; *incidence and rate of hypoglycemic events; *glucose measurements
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: James Malone, MD, 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, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

May 9, 2006

First Submitted That Met QC Criteria

May 10, 2006

First Posted (Estimate)

May 11, 2006

Study Record Updates

Last Update Posted (Estimate)

February 23, 2015

Last Update Submitted That Met QC Criteria

February 20, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H8O-MC-GWBA

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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