A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

August 25, 2015 updated by: AstraZeneca

A Randomized, Double-Blind, Crossover Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

This purpose of this study is to compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

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
      • Los Angeles, California, United States
        • Research Site
      • Spring Valley, California, United States
        • Research Site
    • Florida
      • Miami, Florida, United States
        • Research Site
      • Pembroke Pines, Florida, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Research Site
      • Indianapolis, Indiana, United States
        • Research Site
    • Michigan
      • Detroit, Michigan, United States
        • Research Site
    • Montana
      • Butte, Montana, United States
        • Research Site
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinatti, Ohio, United States
        • Research Site
      • Marion, Ohio, United States
        • Research Site
    • Oregon
      • Eugene, Oregon, United States
        • Research Site
      • Portland, Oregon, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
      • Greer, South Carolina, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Corpus Christi, Texas, United States
        • Research Site
      • San Antonio, Texas, 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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Treatment with metformin for at least 2 months
  • Has HbA1c 7.0% to 11.0%, inclusive, at screening
  • Body mass index (BMI)25 kg/m^2 to 45 kg/m^2, inclusive

  • List of medications that are not allowed or the patient has been on stable treatment for at least 2 months:

    • Hormone replacement therapy (female subjects)
    • Oral contraceptives (female subjects)
    • Antihypertensive agents
    • Lipid-lowering agents
    • Thyroid replacement therapy

Exclusion Criteria

  • Has been treated with exenatide (BYETTA®) or any DPP-4 inhibitor prior to screening
  • Received any study medication or participated in any type of clinical trial within 30 days prior to screening
  • Has donated blood within 60 days of screening visit or is planning to donate blood during the study

  • Treated with any of the following medications:

    • Sulfonylurea or Thiazolidinedione within 3 months of screening;
    • Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®)within 30 days of screening;
    • Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 6 months of screening;
    • Drugs that directly affect gastrointestinal motility, including but not limited to, anticholinergics, macrolide antibiotics, dopamine antagonists, opioids, and Reglan®(metoclopramide);
    • Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption;

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A
Drug: exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Other Names:
  • Byetta
Drug: sitagliptin
oral administration (100mg), once a day in the morning
Other Names:
  • Januvia
Experimental: Sequence B
Drug: exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Other Names:
  • Byetta
Drug: sitagliptin
oral administration (100mg), once a day in the morning
Other Names:
  • Januvia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Exenatide on postprandial glucose
Time Frame: 28 days
To compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of effect of exenatide to the effect of sitagliptin the acetaminophen absorption test, and 6-point self-monitored blood glucose (SMBG) profiles
Time Frame: 28 days
To compare the effect of exenatide to the effect of sitagliptin on the following endpoints in subjects with type 2 diabetes mellitus: postprandial glucose, insulin, insulin secretion rate, glucagon, and triglycerides; gastric emptying, as assessed by the acetaminophen absorption test, and 6-point self-monitored blood glucose (SMBG) profiles
28 days

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

May 1, 2007

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

May 21, 2007

First Submitted That Met QC Criteria

May 21, 2007

First Posted (Estimate)

May 23, 2007

Study Record Updates

Last Update Posted (Estimate)

August 26, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCA403

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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