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

March 19, 2015 updated by: AstraZeneca
This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

165

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

  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Ontario
      • Ajax, Ontario, Canada
        • Research Site
      • Cambridge, Ontario, Canada
        • Research Site
      • Windsor, Ontario, Canada
        • Research Site
  • Mexico
      • Chihuahua, Mexico
        • Research Site
      • Mexico City, Mexico
        • Research Site
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico
        • Research Site
    • Guanajuato
      • Celaya, Guanajuato, Mexico
        • Research Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Research Site
  • Romania
      • Baia Mare, Romania
        • Research Site
      • Brasov, Romania
        • Research Site
      • Bucuresti, Romania
        • Research Site
      • Dolj, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • Suceava, Romania
        • Research Site
  • South Africa
      • Johannesburg, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • California
      • Concord, California, United States
        • Research Site
      • Fresno, California, United States
        • Research Site
    • Colorado
      • Denver, Colorado, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • Ohio
      • Mogadore, Ohio, United States
        • Research Site
    • Oregon
      • Corvallis, Oregon, 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with type 2 diabetes
  • If treated with a thiazolidinedione (TZD) alone, the TZD dose must have been stable for at least 120 days
  • The dose of TZD must be: Rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day)
  • The metformin dose has been stable for at least 90 days
  • Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 10.0%, inclusive.
  • Have a body mass index (BMI): 25 kg/m2 < BMI < 45 kg/m2.

Exclusion Criteria:

  • Have participated in this study previously or any other study using exenatide (AC2993/LY2148568) or glucagon-like peptide-1 (GLP-1) analogs, or have been previously treated with exenatide or GLP-1 analogs
  • Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
  • Have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening
  • Used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening.

  • Are currently treated with any of the following excluded medications:

    • Sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within 3 months prior to screening
    • Alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of screening
    • Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin or vildagliptin) within 3 months prior to screening
    • Pramlintide acetate injection within 3 months prior to screening
    • Drugs that directly affect gastrointestinal motility, including, but not limited to: Metoclopramide, cisapride, and chronic macrolide antibiotics
    • Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start

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
Placebo Comparator: Placebo
Drug: placebo
subcutaneous injection, volume equivalent to 5 mcg or 10 mcg of active drug, twice a day
Experimental: Exenatide twice daily (BID)
Drug: exenatide
subcutaneous injection, 5 mcg or 10 mcg, twice a day (BID)
Other Names:
  • Byetta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Hemoglobin (HbA1c)
Time Frame: baseline and 26 weeks
Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline)
baseline and 26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Achieving HbA1c <= 7%
Time Frame: 26 weeks
Percentage of intent-to-treat (ITT) patients who had HbA1c > 7% at baseline that decreased to <= 7% at endpoint (Week 26 or early discontinuation)
26 weeks
Percentage of Patients Achieving HbA1c <= 6.5%
Time Frame: 26 weeks
Percentage of ITT patients who had achieved HbA1c <= 6.5% at endpoint (Week 26 or early discontinuation)
26 weeks
Change in Fasting Serum Glucose (FSG)
Time Frame: baseline and 26 weeks
Change in FSG from baseline to endpoint (26 weeks)
baseline and 26 weeks
Change in Body Weight
Time Frame: baseline and 26 weeks
Change in body weight from baseline to endpoint (26 weeks)
baseline and 26 weeks
Change in Waist Circumference
Time Frame: baseline and 26 weeks
Change in waist circumference from baseline to endpoint (26 weeks)
baseline and 26 weeks
Change in Beta-cell Function
Time Frame: baseline and 26 weeks
Change in homeostatic model assessment-beta cell (HOMA-B) from baseline to endpoint (Week 26) (outcome measure is presented as the ratio of endpoint HOMA-B divided by baseline HOMA-B). HOMA-B is a measure of pancreatic beta-cell function.
baseline and 26 weeks
Change in Insulin Sensitivity.
Time Frame: baseline and 26 weeks
Change in homeostatic model assessment-insulin sensitivity (HOMA-S) from baseline to endpoint (26 weeks) (outcome measure is presented as the ratio of endpoint HOMA-S divided by baseline HOMA-S).
baseline and 26 weeks
Number of Subjects Who Experienced an Episode of Minor Hypoglycemia
Time Frame: 26 weeks
Overall number of subjects who experienced an episode of minor hypoglycemia.
26 weeks
Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score
Time Frame: baseline and 26 weeks
IWQOL-Lite analysis of change from baseline to endpoint (26 weeks). IWQOL-Lite is a 31-item questionnaire, assessing the domains of physical function, self-esteem, sexual life, public distress, and work. Response categories for each item range from 1 = "never true" to 5 = "always true."
baseline and 26 weeks
Change in Euroqol - 5 Domain Quality of Life (EQ-5D) Score
Time Frame: baseline and 26 weeks
EQ-5D Score - change from baseline to endpoint (26 weeks). EQ-5D is a 5-item questionnaire used to characterize current health states. The tool and accompanying visual analog scale (VAS) assess 5 domains of quality of life, including mobility, self-care, usual activity, pain, and anxiety/depression. Weights are used to score the responses to the 5 domains, with 3 options possible in each domain: extreme problems, some/moderate problems, or no problems. Scores range from 0 to 1, with a score of 1 representing a perfect health state.
baseline and 26 weeks

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

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, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 28, 2008

First Posted (Estimate)

January 29, 2008

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H8O-MC-GWCG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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