Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

February 19, 2015 updated by: AstraZeneca

A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 2

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
      • La Jolla, California, United States, 92037
        • The Whittier Institute for Diabetes
      • San Diego, California, United States, 92161
        • VA Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20003
        • Medstar Research Institute
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Internal Medicine Associates, Department of Research
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Largo, Florida, United States, 33770
        • Innovative Research of West Florida
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Grand Rapids, Michigan, United States, 49506
        • Grand Rapids Associated Internists
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Radiant Research, Inc.
    • Montana
      • Bozeman, Montana, United States, 59715
        • Internal Medicine Associates
      • Butte, Montana, United States, 59701
        • Mercury Street Medical Group
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Lovelace Scientific Resources
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc.
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Metrolina Medical Research
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research Associates
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Radiant Research
      • Marion, Ohio, United States, 43302
        • Smith Clinic Research
    • Oregon
      • Portland, Oregon, United States, 97239
        • Radiant Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Philadelphia Health Associates - Adult Medicine
    • Texas
      • San Antonio, Texas, United States, 78229
        • S.A.M. Clinical Research Center
      • San Antonio, Texas, United States, 78229-4801
        • Diabetes and Glandular Disease Research Associates
    • Virginia
      • Richmond, Virginia, United States, 23249
        • McGuire VA Medical Center
    • Washington
      • Spokane, Washington, United States, 99202
        • Rockwood Clinic

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:

  • Subject has type 2 diabetes mellitus treated with diet and exercise modification alone or in combination with one oral antidiabetic agent for no longer than 4 years.

Exclusion Criteria:

  • Subject has a clinically significant history or presence of any of the following conditions: (a) Hepatic disease, (b) Renal disease, (c) Central nervous system disease, (d) Gastrointestinal disease (e) Pulmonary disease (f) Hematologic disease.
  • Subject is currently treated with any of the following excluded medications: (a) Metformin/sulfonylurea combination therapy (b) Thiazolidinediones (c) Insulin as outpatient therapy (d) Regular use of drugs that directly affect gastrointestinal motility (e) Regular use of systemic corticosteroids by oral, intravenous (IV), or intramuscular (IM) route, or potent, inhaled, intrapulmonary, or intranasal steroids known to have a high rate of systemic absorption (f) Regular use of medications with addictive potential such as opiates, narcotics and tranquilizers (g) Antineoplastic agents (h) Transplantation medications (i) Prescription weight-loss medications.

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: A1 - Placebo 0.04 mL twice daily
Drug: Placebo 0.04 mL twice daily
Subcutaneously injected, 0.04 mL, twice daily
Placebo Comparator: A2 - Placebo 0.04 mL once daily
Drug: Placebo 0.04 mL once daily
Subcutaneously injected, 0.04 mL, once daily
Placebo Comparator: A3 - Placebo 0.08 mL once daily
Drug: Placebo 0.08 mL once daily
Subcutaneously injected, 0.08 mL, once daily
Experimental: B - Exenatide 10 mcg twice daily
Drug: B - Exenatide 10 mcg twice daily
Subcutaneously injected, 10 mcg (0.04 mL), twice daily
Other Names:
  • synthetic exendin-4
  • ACC2993
Experimental: C - Exenatide 10 mcg once daily
Drug: C - Exenatide 10 mcg once daily
Subcutaneously injected, 10 mcg (0.04 mL), once daily
Other Names:
  • synthetic exendin-4
  • ACC2993
Experimental: D - Exenatide 20 mcg once daily
Drug: Exenatide 20 mcg once daily
Subcutaneously injected, 20 mcg (0.08 mL), once daily
Other Names:
  • synthetic exendin-4
  • ACC2993

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28
Time Frame: Baseline, Day 28
Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28)
Baseline, Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28
Time Frame: Baseline, Day 14, Day 28
Change in serum fructosamine concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
Baseline, Day 14, Day 28
Change in body weight from Baseline to Day 14 and to Day 28
Time Frame: Baseline, Day 14, Day28
Change in body weight from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
Baseline, Day 14, Day28
Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28
Time Frame: Baseline, Day 14, Day 28
Change in fasting plasma glucose concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
Baseline, Day 14, Day 28
Change in postprandial blood glucose concentrations from Baseline to Day 28
Time Frame: Baseline, Week 28
Change in postprandial blood glucose concentrations from Baseline Visit 3 (Day 1) to study termination (Day 28)
Baseline, Week 28

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

September 1, 2003

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

June 18, 2004

First Submitted That Met QC Criteria

June 21, 2004

First Posted (Estimate)

June 22, 2004

Study Record Updates

Last Update Posted (Estimate)

February 23, 2015

Last Update Submitted That Met QC Criteria

February 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2993-120

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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