A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

Phase 4 Completed 255 enrolled AstraZeneca Eli Lilly and Company · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.

Timeline

Start: 2009-03
Primary completion: 2010-04
Completion: 2010-04

Outcome

Missed primary endpoint

paper Non-inferiority (0.4% margin) of SWITCH to ADD treatment, measured by change in HbA(1c) from baseline to week 20, was not shown PMID 22375612 ↗

registry Least Square Mean Difference 0.30 (95% CI 0.07 to 0.53) NCT00870194 ↗

Publications

Violante R, Oliveira JH, Yoon KH, Reed VA, Yu MB, Bachmann OP, Ludemann J, Chan JY. A randomized non-inferiority study comparing the addition of exenatide twice daily to sitagliptin or switching from sitagliptin to exenatide twice daily in patients with type 2 diabetes experiencing inadequate glycaemic control on metformin and sitagliptin. Diabet Med. 2012 Nov;29(11):e417-24. doi: 10.1111/j.1464-5491.2012.03624.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Exenatide	Peptide	10 ug	Subcutaneous
Subject	Sitagliptin	Small molecule	100 mg	Oral