CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 122 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Exenatide 5 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00658021
NCT00658021Phase 3Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Apr 14, 2008·Updated Dec 1, 2020

In Brief

A Phase 3 clinical trial evaluating Placebo and Exenatide for Type 2 Diabetes. Completed, enrolled 122 participants across 53 sites in 8 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesBrazil, India, Mexico, Philippines, Russia, South Africa, South Korea, United States
CollaboratorsQuintiles, Inc.

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 14, 2008
Enrollment StartMay 30, 2008
Primary CompletionApr 18, 2019
Study CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 10.9 yearsPosted 18.2 years ago

Interventions

Placebodrug

Subcutaneous injection, twice a day

Exenatidedrug

Subcutaneous injection, 5 µg, twice a day

Exenatidedrug

Subcutaneous injection,10 µg, twice a day