A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus

February 19, 2015 updated by: AstraZeneca

A Randomized, Single-Blind, Dose-Rising, Placebo-Controlled, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus

This study will be the first evaluation of exenatide in adolescent subjects with type 2 diabetes mellitus and is designed to evaluate the blood levels of the drug (pharmacokinetics), the drug's biochemical and physiological effects (pharmacodynamics), and tolerability of exenatide in these subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

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
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • San Diego, California, United States
        • Research Site
    • Colorado
      • Denver, Colorado, United States
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States
        • Research Site
    • Texas
      • 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

10 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 3 months.
  • Has HbA1c 6.0% to 11.0%, inclusive, at screening.
  • Has a body weight of >= 50 kg at screening.

Exclusion Criteria:

  • Received any investigational drug or has participated in any type of clinical trial within 3 months prior to screening.
  • Currently participates in any other interventional study.

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

    • Sulfonylurea chlorpropamide
    • Thiazolidinedione within 3 months of screening.
    • Αlpha glucosidase inhibitor within 3 months of screening.
    • Meglitinide within 3 months of screening.
    • Insulin within 3 months of screening.
    • Pramlintide within 3 months of screening.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
Exenatide 2.5 mcg - Exenatide 5 mcg - Placebo 0.02 mL
Drug: Exenatide - Exenatide - Placebo
Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose, followed by placebo 0.02 mL, single dose. All are subcutaneous injections.
Other Names:
  • Byetta
Experimental: Sequence 2
Exenatide 2.5 mcg - Placebo 0.02 mL - Exenatide 5 mcg
Drug: Exenatide - Placebo - Exenatide
Exenatide 2.5 mcg, single dose, followed by placebo 0.02 mL, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections.
Other Names:
  • Byetta
Experimental: Sequence 3
Placebo 0.02 mL - Exenatide 2.5 mcg - Exenatide 5 mcg
Drug: Placebo - Exenatide - Exenatide
Placebo 0.02 mL, single dose, followed by Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections.
Other Names:
  • Byetta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the pharmacokinetics of exenatide
Time Frame: Three day-long (8 hour) assessments over a 5-week period
To assess pharmacokinetics of exenatide by measuring peak plasma time, time to peak concentration, terminal elimination half-life, apparent elimination time constant, apparent clearance, apparent volume of distribution, and area under concentration curve.
Three day-long (8 hour) assessments over a 5-week period
To assess the pharmacodynamics of exenatide
Time Frame: Three day-long (8 hour) assessments over a 5-week period
To assess the pharmacodynamics of exenatide by measuring plasma glucose, serum insulin, and plasma glucagon: absolute and incremental area under the curve 0-3 hours), absolute and incremental area under the curve (0-6 hours), areas under the concentration-time curve (0-6 h), peak plasma contration, and time to peak concentration.
Three day-long (8 hour) assessments over a 5-week period
Number of adverse events
Time Frame: Visit 2 through Visit 4
Adverse events will be assessed at all visits after the Screening Visit [Visit 2 (first time subject is dosed) through Visit 4 (study termination)]. All events assessed with special attention to changes in vital signs, ECGs, and laboratory values
Visit 2 through Visit 4

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, 2006

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

November 14, 2005

First Submitted That Met QC Criteria

November 14, 2005

First Posted (Estimate)

November 16, 2005

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

  • 2993-124

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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