drugset / Trial / NCT01318070

Efficacy and Safety of Alogliptin Used Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan

NCT01318070 ↗

Phase 2/3 Completed 339 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with a thiazolidine taken QD in type 2 diabetic patients with uncontrolled blood glucose.

Timeline

Start
2007-11
Primary completion
2008-10
Completion
2008-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD vs Pioglitazone 15 mg or 30 mg QD; Median Difference (Final Values) -0.717 (95% CI -0.848 to -0.586) NCT01318070 ↗

registry analysis (superiority or other test); Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD vs Pioglitazone 15 mg or 30 mg QD; Mean Difference (Final Values) -0.773 (95% CI -0.913 to -0.634) NCT01318070 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Alogliptin Unknown 12.5 mg Oral
Subject Alogliptin Unknown 25 mg Oral
Comparator Pioglitazone Small molecule 15 mg Oral
Comparator Pioglitazone Small molecule 30 mg Oral