drugset / Trial / NCT01956305

Randomized, Placebo-controlled, 2 Period, Single-blind, Sequential, Multiple Ascending Dose Study

NCT01956305 ↗

Phase 1 Completed 48 enrolled Daiichi Sankyo
RandomizedCrossoverSingle-blindTreatment

Summary

DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be a randomized, placebo-controlled, blinded, sequential, multiple ascending dose study to assess the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of multiple doses of DS-7309 in subjects with T2DM.

Timeline

Start
2013-09
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject DS-7309 Unknown 10 mg —
Subject DS-7309 Unknown 20 mg —
Subject DS-7309 Unknown 40 mg —
Subject DS-7309 Unknown 75 mg —
Subject DS-7309 Unknown 150 mg —
Subject Metformin Small molecule 500 mg —