drugset / Trial / NCT00658021

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

NCT00658021

Phase 3 Completed 122 enrolled AstraZeneca Quintiles, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2008-05-30
Primary completion
2019-04-18
Completion
2020-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Exenatide Peptide 5 ug Subcutaneous
Subject Exenatide Peptide 10 ug Subcutaneous