Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.

Summary

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with a sulfonylurea in adults with type 2 diabetes mellitus.

Timeline

Start

2006-04

Primary completion

2007-06

Completion

2007-06

Outcome

Met primary endpoint

registry Placebo vs Alogliptin 12.5 mg QD; p <0.001; Mean Difference (Final Values) -0.39 (95% CI -0.59 to -0.19) NCT00286468 ↗

registry Placebo vs Alogliptin 25 mg QD; p <0.001; Mean Difference (Final Values) -0.53 (95% CI -0.73 to -0.33) NCT00286468 ↗

paper Significantly greater least squares (LS) mean reductions in HbA1c were seen at week 26 with alogliptin 12.5 mg (-0.38%) and 25 mg (-0.52%) vs. placebo (+0.01%; p < 0.001) PMID 19125778 ↗

Publications

• Results Pratley RE, Kipnes MS, Fleck PR, Wilson C, Mekki Q; Alogliptin Study 007 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes Obes Metab. 2009 Feb;11(2):167-76. doi: 10.1111/j.1463-1326.2008.01016.x.
• Results Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. doi: 10.1111/j.1532-5415.2009.02484.x. Epub 2009 Sep 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alogliptin	Unknown	12.5 mg	Oral
Subject	Alogliptin	Unknown	25 mg	Oral
Background	Glyburide	Small molecule	—	—

Indications