drugset / Trial / NCT00729326

Comparison of the Effect of Exenatide Versus Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

NCT00729326 ↗

Phase 4 Completed 83 enrolled AstraZeneca Eli Lilly and Company · collab
RandomizedCrossoverDouble-blindTreatment

Summary

This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione \[TZD\]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.

Timeline

Start
2008-08
Primary completion
2009-10
Completion
2009-10

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Exenatide: -41.65 (Standard Error 2.55) mg/dL LEAST_SQUARES_MEAN Sitagliptin: -29.56 (Standard Error 2.58) mg/dL analysis (superiority or other test); Exenatide vs Sitagliptin; p <.001 NCT00729326 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Exenatide Peptide 5 ug Subcutaneous
Subject Exenatide Peptide 10 ug Subcutaneous
Subject Sitagliptin Small molecule 100 mg Oral