Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes

February 23, 2015 updated by: AstraZeneca

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine Safety and Pharmacokinetics of Exenatide Long-Acting Release Administered Weekly in Subjects With Type 2 Diabetes Mellitus

Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

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
      • Walnut Creek, California, United States
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • Montana
      • Butte, Montana, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
    • Texas
      • San Antonio, Texas, United States
        • Research Site
    • Washington
      • Olympia, Washington, 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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has type 2 diabetes treated with either: *A stable regimen of metformin for a minimum of 3 months, and/or *Diet modification and exercise for a minimum of 3 months.
  • Has HbA1c of 7.1% to 11.0%, inclusive.
  • Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.

Exclusion Criteria:

  • Received any investigational drug within 3 months prior to screening.
  • Is currently treated with any of the following excluded medications: *Thiazolidinediones within 3 months of screening; * Sulfonylureas within 3 months of screening; * Insulin within 1 year of screening.
  • Participated previously in an exenatide clinical study.

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: Group A1
Placebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR
Drug: placebo
Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg
Drug: placebo
Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 2.0 mcg
Placebo Comparator: Group A2
Placebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR
Drug: placebo
Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg
Drug: placebo
Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 2.0 mcg
Experimental: Group B
Exenatide lead-in followed by exenatide LAR 0.8 mg weekly
Drug: Exenatide LAR
Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg.
Other Names:
  • Bydureon
Drug: Exenatide LAR
Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 2.0 mcg.
Other Names:
  • Bydureon
Experimental: Group C
Exenatide lead-in followed by exenatide LAR 2.0 mg weekly
Drug: Exenatide LAR
Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg.
Other Names:
  • Bydureon
Drug: Exenatide LAR
Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 2.0 mcg.
Other Names:
  • Bydureon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the safety, tolerability, and pharmacokinetics of exenatide long-acting release (LAR) administered weekly by subcutaneous (SC) injection in subjects with type 2 diabetes (T2DM)
Time Frame: Time intervals: 0 min to 12 hours on Day 1 for a duration of 12 hours, from Day 1; 0 mininutes to Week 1 for a duration of 168 hours, and from Week 14 to Week 15 for a duration of 168 hours
Time intervals: 0 min to 12 hours on Day 1 for a duration of 12 hours, from Day 1; 0 mininutes to Week 1 for a duration of 168 hours, and from Week 14 to Week 15 for a duration of 168 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine the effect on various pharmacodynamic parameters of exenatide LAR administered weekly by subcutaneous injection in subjects with Type 2 Diabetes Mellitus
Time Frame: Various time intervals from Day 1 to Week 15
Various time intervals from Day 1 to Week 15
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27).
Time Frame: Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27
Change in HbA1c from baseline Visit 3 (Day -3) to Visit 25 (Week 15) and to each intermediate visit where applicable, and to study termination.
Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27
Change in fasting glucose concentrations from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27)
Time Frame: Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27
Change in fasting glucose concentrations from baseline Visit 3 (Day -3) to Visit 25 (Week 15) and to each intermediate visit where applicable, and to study termination
Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27
Change in body weight from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27)
Time Frame: Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27
Change in body weight (kg) from baseline Visit 3 (Day -3) to Visit 25 (Week 15) and to each intermediate visit where applicable, and to study termination
Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27
Change in seven-point glucose concentrations from Baseline to Week 14 and Week 15
Time Frame: Baseline, 3 days between Day -7 and Day -3, and 3 days between Week 14 and Week 15
Change in seven-point glucose concentrations from baseline (collected on 3 days between Visit 2 [Day -7] and Visit 3 [Day -3]) to Visit 25 (collected on 3 days between Visit 20 [Week 14] and Visit 25 [Week 15])
Baseline, 3 days between Day -7 and Day -3, and 3 days between Week 14 and Week 15

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

February 1, 2005

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

February 17, 2005

First Submitted That Met QC Criteria

February 17, 2005

First Posted (Estimate)

February 18, 2005

Study Record Updates

Last Update Posted (Estimate)

February 24, 2015

Last Update Submitted That Met QC Criteria

February 23, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2993LAR-104

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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