drugset / Trial / NCT02324569

A Phase 4, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 4, Open-label, Long-term Study of SYR-472 (100 mg) in Combination With Insulin in Patients With Type 2 Diabetes

NCT02324569

Phase 3 Completed 240 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purposes of this study is to evaluate the efficacy and safety of SYR-472 when administered at a dose of 100 mg once weekly as an add-on to insulin therapy compared with placebo in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy; and to evaluate the long-term efficacy and safety of SYR-472 when administered at a dose of 100 mg once weekly as an add-on to insulin therapy in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy.

Timeline

Start
2014-12-27
Primary completion
2016-12-28
Completion
2016-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Trelagliptin Small molecule 100 mg Oral