Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes

NCT00658021 · Completed

Last updated 2026-05-28

This clinical trial tested the safety and effects of the medication exenatide, alone and with other diabetes drugs, in teenagers with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 122 people

Who can join Ages 10–17 · all sexes

Timeline Started 2008-05 · est. completion 2020-04

Where 53 sites · Brazil, India, Mexico, Philippines, Russia, South Africa, South Korea, United States

What this study is testing ClinicalTrials.gov NCT00658021 ↗

Description as written by the study sponsor.

The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2 diabetes who are naïve to antidiabetes agents, or patients who are being treated with metformin, an SU, or a combination of metformin and an SU

Treatments tested

Placebo Drug

Subcutaneous injection, twice a day
Exenatide Drug

Subcutaneous injection, 5 µg, twice a day
Exenatide Drug

Subcutaneous injection,10 µg, twice a day

Main thing measured	Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00658021 ↗