drugset / Trial / NCT00286429

Efficacy and Safety Study of Alogliptin and Insulin in the Treatment of Type 2 Diabetes.

NCT00286429 ↗

Phase 3 Completed 390 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine the efficacy and safety of alogliptin, once daily (QD), taken in combination with insulin for the treatment of Type 2 Diabetes.

Timeline

Start
2006-02
Primary completion
2007-05
Completion
2007-05

Outcome

Met primary endpoint

registry Placebo vs Alogliptin 25 mg QD; p <0.001; Mean Difference (Final Values) -0.59 (95% CI -0.80 to -0.37); ANCOVA NCT00286429 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Alogliptin Unknown 12.5 mg Oral
Subject Alogliptin Unknown 25 mg Oral
Comparator Insulin Protein / enzyme biologic — —