Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

February 20, 2015 updated by: AstraZeneca

Efficacy of Exenatide Compared With Insulin Glargine in Patients With Type 2 Diabetes Using Metformin or Sulfonylurea for Whom Insulin is the Next Appropriate Therapy

This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

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

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia
        • Research Site
    • South Australia
      • Daw Park, South Australia, Australia
        • Research Site
      • Fullarton, South Australia, Australia
        • Research Site
    • Victoria
      • Box Hill, Victoria, Australia
        • Research Site
      • East Ringwood, Victoria, Australia
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Piraeus, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Pecs, Hungary
        • Research Site
      • Veszprem, Hungary
        • Research Site
      • Zalaegerszeg, Hungary
        • Research Site
  • Italy
      • Bari, Italy
        • Research Site
      • Bergamo, Italy
        • Research Site
      • Catania, Italy
        • Research Site
      • Milan, Italy
        • Research Site
      • Perugia, Italy
        • Research Site
      • Rome, Italy
        • Research Site
  • Mexico
      • Mexico City, Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
      • Zapopan, Jalisco, Mexico
        • Research Site
    • N.l.
      • Monterrey, N.l., Mexico
        • Research Site
  • Poland
      • Bydgoszcz, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Lublin, Poland
        • 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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to screening.
  • HbA1c between 7.1% and 11.0%, inclusive.
  • Insulin therapy should be the next appropriate step of diabetes treatment.
  • Body Mass Index (BMI) >25 kg/m2 and <40 kg/m2.

Main Exclusion Criteria:

  • Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs.
  • Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exenatide/insulin glargine
Arm that first receives exenatide, then crosses over to insulin glargine
Drug: exenatide/insulin glargine
Subcutaneously injected exenaide 10 mcg twice daily for 16 weeks; then insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels
Other Names:
  • Byetta
  • AC2003
  • syntheitc exenden-4
Experimental: Insulin glargine/exenatide
Arm that first receives insulin glargine, then crosses over to exenatide
Drug: insulin glargine/exenatide
Subcutaneously injected insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels; then exenaide 10 mcg twice daily for 16 weeks
Other Names:
  • Byetta
  • AC2993
  • synthetic exenden-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period.
Time Frame: Baseline, Week 16, Week 32
Change in HbA1c from Baseline to the end of each 16-week period. There is one 16-week period of exenatide treatment and one 16-week period of insulin glargine.
Baseline, Week 16, Week 32

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient-reported outcomes from Baseline to the end of each 16-week period
Time Frame: Baseline, Week 16, Week 32
Change in patient-based outcomes (Hypoglycemic Fear Survey, patient-preference questionnaires [Treatment Evaluation and Treatment Preference questionnaires), Diabetes Symptom Checklist-Revised, Diabetes Treatment Flexibility Scale, Psychological General Well-Being Index, and the EuroQol (EQ-5D) instrument] from Baseline to the end of each 16-week exenatide or insulin glargine period
Baseline, Week 16, Week 32

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

September 1, 2004

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

December 17, 2004

First Submitted That Met QC Criteria

December 17, 2004

First Posted (Estimate)

December 20, 2004

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-GWAO

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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