Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes

Phase 3 Completed 506 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin).

Timeline

Start: 2010-12
Primary completion: 2011-12
Completion: 2011-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Alogliptin Monotherapy; p <0.001; LS Mean Difference -0.58 (95% CI -0.78 to -0.37); ANCOVA NCT01289119 ↗

registry analysis (superiority or other test); Metformin vs Metformin + Alogliptin Add-on Therapy; p <0.001; LS Mean Difference -0.69 (95% CI -0.87 to -0.51); ANCOVA NCT01289119 ↗

registry analysis (superiority or other test); Pioglitazone vs Pioglitazone + Alogliptin Add-on Therapy; p <0.001; LS Mean Difference -0.52 (95% CI -0.75 to -0.28); ANCOVA NCT01289119 ↗

Publications

El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alogliptin	Unknown	25 mg	Oral
Background	Metformin	Small molecule	—	—
Background	Pioglitazone	Small molecule	—	—