drugset / Trial / NCT00494312
Safety Study of Pioglitazone Compared To Glyburide on Liver Function
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine the liver safety of pioglitazone, once daily (QD), versus glyburide taken with metformin and insulin.
Timeline
- Start
- 2000-10
- Primary completion
- 2005-06
- Completion
- 2005-06
Publications
- Results Tolman KG, Fonseca V, Tan MH, Dalpiaz A. Narrative review: hepatobiliary disease in type 2 diabetes mellitus. Ann Intern Med. 2004 Dec 21;141(12):946-56. doi: 10.7326/0003-4819-141-12-200412210-00011.
- Tolman KG, Freston JW, Kupfer S, Perez A. Liver safety in patients with type 2 diabetes treated with pioglitazone: results from a 3-year, randomized, comparator-controlled study in the US. Drug Saf. 2009;32(9):787-800. doi: 10.2165/11316510-000000000-00000.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glyburide | Small molecule | 15 mg | Oral |
| Subject | Pioglitazone | Small molecule | 45 mg | Oral |