Safety Comparison of Pioglitazone and Glyburide in Type 2 Diabetes Subjects With Mild to Moderate Congestive Heart Failure

Summary

The purpose of this study is to compare the safety of Pioglitazone, once daily (QD), to Glyburide in Type 2 Diabetes Subjects with Mild to Moderate Congestive Heart Failure

Timeline

Start

2000-06

Primary completion

2003-10

Completion

2003-10

Outcome

Missed primary endpoint

Stopped: “Higher incidence of hospitalization for congestive heart failure in pioglitazone-treated subjects compared to glyburide treated subjects.”

paper An earlier time to onset and higher incidence of the primary endpoint was noted with pioglitazone (13%) versus glyburide (8%) (P = .024). PMID 18672190 ↗

Publications

• Results Giles TD, Miller AB, Elkayam U, Bhattacharya M, Perez A. Pioglitazone and heart failure: results from a controlled study in patients with type 2 diabetes mellitus and systolic dysfunction. J Card Fail. 2008 Aug;14(6):445-52. doi: 10.1016/j.cardfail.2008.02.007. Epub 2008 May 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Glyburide	Small molecule	10 mg	Oral
Subject	Pioglitazone	Small molecule	30 mg	Oral

Indications