drugset / Trial / NCT02068443

Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy

NCT02068443

Phase 3 Completed 374 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to evaluate the efficacy and safety of 24-week treatment with metformin hydrochloride 500 mg once daily added on to alogliptin (SYR-322) 25 mg in type 2 diabetic patients with inadequate glycemic control despite treatment with alogliptin 25 mg in addition to diet and exercise therapy.

Timeline

Start
2014-02
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 250 mg Oral
Subject Metformin Small molecule 500 mg Oral
Background Alogliptin Unknown 25 mg Oral