Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

Summary

This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.

Timeline

Start

2006-09

Primary completion

2011-03

Completion

2011-03

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); Exen + Met vs Glim + Met; p = 0.0020; Hazard Ratio 0.748 (95% CI 0.623 to 0.899); Regression, Cox NCT00359762 ↗

registry analysis (superiority or other test); Exen + Met vs Glim + Met; p = 0.0315; Log Rank NCT00359762 ↗

Publications

• Simo R, Guerci B, Schernthaner G, Gallwitz B, Rosas-Guzman J, Dotta F, Festa A, Zhou M, Kiljanski J. Long-term changes in cardiovascular risk markers during administration of exenatide twice daily or glimepiride: results from the European exenatide study. Cardiovasc Diabetol. 2015 Sep 4;14:116. doi: 10.1186/s12933-015-0279-z.
• Schernthaner G, Rosas-Guzman J, Dotta F, Guerci B, Simo R, Festa A, Kiljanski J, Zhou M, Gallwitz B. Treatment escalation options for patients with type 2 diabetes after failure of exenatide twice daily or glimepiride added to metformin: results from the prospective European Exenatide (EUREXA) study. Diabetes Obes Metab. 2015 Jul;17(7):689-98. doi: 10.1111/dom.12471. Epub 2015 May 8.
• Gallwitz B, Guzman J, Dotta F, Guerci B, Simo R, Basson BR, Festa A, Kiljanski J, Sapin H, Trautmann M, Schernthaner G. Exenatide twice daily versus glimepiride for prevention of glycaemic deterioration in patients with type 2 diabetes with metformin failure (EUREXA): an open-label, randomised controlled trial. Lancet. 2012 Jun 16;379(9833):2270-8. doi: 10.1016/S0140-6736(12)60479-6. Epub 2012 Jun 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Exenatide	Peptide	5 ug	Subcutaneous
Subject	Exenatide	Peptide	10 ug	Subcutaneous
Comparator	Glimepiride	Small molecule	—	Oral

Indications