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

NCT00254254 · Completed

Last updated 2026-05-28

This study tests how the diabetes medication exenatide is absorbed, processed, and tolerated in teenagers with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, single-blind treatment study

Participants 13 people

Who can join Ages 10–16 · all sexes

Timeline Started 2006-02 · est. completion 2007-02

Where 5 sites · United States

What this study is testing ClinicalTrials.gov NCT00254254 ↗

Description as written by the study sponsor.

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.

Treatments tested

Exenatide - Exenatide - Placebo also known as Byetta Drug

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.
Exenatide - Placebo - Exenatide also known as Byetta Drug

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.
Placebo - Exenatide - Exenatide also known as Byetta Drug

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.

Main thing measured	To assess the pharmacokinetics of exenatide
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00254254 ↗