drugset / Trial / NCT00286455
Efficacy and Safety of Alogliptin in Subjects With Type 2 Diabetes
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), in adults with type 2 diabetes.
Timeline
- Start
- 2006-02
- Primary completion
- 2007-07
- Completion
- 2007-07
Outcome
Met primary endpoint
paper At week 26, mean change in A1C was significantly greater (P < 0.001) for 12.5 mg (-0.56%) and 25 mg (-0.59%) alogliptin than placebo (-0.02%). PMID 18809631 ↗
registry analysis (superiority or other test); Placebo QD vs Alogliptin 25 mg QD; p <0.001; Mean Difference (Final Values) -0.57 (95% CI -0.80 to -0.35); ANCOVA NCT00286455 ↗
Publications
- Results DeFronzo RA, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 010 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study. Diabetes Care. 2008 Dec;31(12):2315-7. doi: 10.2337/dc08-1035. Epub 2008 Sep 22.
- 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 |