drugset / Trial / NCT00603239

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin

NCT00603239 ↗

Phase 3 Completed 165 enrolled AstraZeneca Eli Lilly and Company · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.

Timeline

Start
2008-01
Primary completion
2009-07
Completion
2009-07

Outcome

Met primary endpoint

paper Exenatide reduced HbA(1c) significantly more than placebo [-0.84% (s.e. 0.20) vs. -0.10% (0.23), treatment difference -0.74% (0.16), p < 0.001)]. PMID 20977576 ↗

Drugs

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