Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes

February 20, 2015 updated by: AstraZeneca

Safety and Efficacy of Exenatide Taken Before Lunch and Before Dinner Compared With Before Breakfast and Before Dinner in Patients With Type 2 Diabetes Using Oral Antidiabetic Therapy

This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

377

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

  • Brazil
      • Campinas, Brazil
        • Research Site
      • Curitiba, Brazil
        • Research Site
      • Fortaleza, Brazil
        • Research Site
      • Goiania, Brazil
        • Research Site
      • Porto Alegre, Brazil
        • Research Site
      • Rio de Janeiro, Brazil
        • Research Site
      • Salvador, Brazil
        • Research Site
      • Sao Jose Do Rio Preto, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
  • Mexico
      • Aguascalientes, Mexico
        • Research Site
      • Mexico City, Mexico
        • Research Site
      • San Luis Potosi, Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Research Site
    • Yucatan
      • Merida, Yucatan, Mexico
        • 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:

  • Diagnosed with type 2 diabetes.
  • Have been treated with one of the following treatment regimens for at least three months prior to screening: *metformin alone; *sulfonylurea (SU) alone; *thiazolidinedione (TZD) alone; *a combination of metformin and SU; *a combination of metformin and TZD.
  • HbA1c between 7.1% and 10.0%, inclusive.
  • Body Mass Index (BMI) > 25 kg/m^2 and < 45 kg/m^2

Exclusion Criteria:

  • 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 prior to screening.
  • Have characteristics contraindicating metformin, SU, or TZD use.
  • Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
  • Have used any prescription drug to promote weight loss within 3 months prior to screening.
  • Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: *insulin within 3 months prior to screening; *alpha-glucosidase inhibitors within 3 months prior to screening; *meglitinides within 3 months prior to screening; *drugs that directly affect gastrointestinal motility

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: 1 - exenatide before breakfast and dinner
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)
Other Names:
  • Byetta
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)
Other Names:
  • Byetta
Active Comparator: 2 - exenatide before lunch and dinner
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)
Other Names:
  • Byetta
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)
Other Names:
  • Byetta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12
Time Frame: Baseline, Week 12
Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight from Baseline to Week 12, and if measured, at each visit
Time Frame: Baseline, Weeks 4, 8, 12
Change in body weight (kg) from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)
Baseline, Weeks 4, 8, 12
Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit
Time Frame: Baseline, Weeks 4, 8, 12
Change in FGS from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)
Baseline, Weeks 4, 8, 12
Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12
Time Frame: Baseline, Weeks 4, 8, 12
Changes in glucose measured at different times throughout the day derived from 7-point SMBG profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)
Baseline, Weeks 4, 8, 12

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, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

August 1, 2006

First Submitted That Met QC Criteria

August 1, 2006

First Posted (Estimate)

August 3, 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-CR-GWBH

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.

Clinical Trials on Type 2 Diabetes

Clinical Trials on exenatide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe