drugset / Trial / NCT02647320

12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin

NCT02647320

Phase 2 Completed 298 enrolled Daiichi Sankyo
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.

Timeline

Start
2016-01
Primary completion
2017-01-31
Completion
2017-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject FIRUGLIPEL Small molecule 25 mg Oral
Subject FIRUGLIPEL Small molecule 50 mg Oral
Subject FIRUGLIPEL Small molecule 75 mg Oral
Comparator Sitagliptin Small molecule 100 mg Oral