drugset / Trial / NCT00286494
Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with pioglitazone in adults with type 2 diabetes mellitus
Timeline
- Start
- 2006-02
- Primary completion
- 2007-08
- Completion
- 2007-08
Outcome
Met primary endpoint
registry Placebo vs Alogliptin 25 mg QD; p <0.001; Mean Difference (Final Values) -0.61 (95% CI -0.80 to -0.41); ANCOVA NCT00286494 ↗
paper Least squares (LS) mean change in HbA(1c) was significantly (p < 0.001) greater for alogliptin 12.5 mg (-0.66%) or 25 mg (-0.80%) than for placebo (-0.19%). PMID 19650752 ↗
Publications
- Results Pratley RE, Reusch JE, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 009 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin. 2009 Oct;25(10):2361-71. doi: 10.1185/03007990903156111.
- 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 | Pioglitazone | Small molecule | 30 mg | Oral |
| Background | Pioglitazone | Small molecule | 45 mg | Oral |