NCT01956305

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

A Single Blind, (Subject and Investigator Blinded, Sponsor Unblinded), Two-Period, Placebo-Controlled, Randomized, Sequential, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS 7309 In Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be a randomized, placebo-controlled, single-blind (subject and investigator-blinded, sponsor-unblinded), sequential, multiple ascending dose study to assess the safety, tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) of multiple doses of DS-7309 in subjects with T2DM. The safety and tolerability of each new dose level will be tested in a single day administration prior to start of repeated dosing.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	DS-7309	DS-7309 powder in bottle
DRUG	placebo	placebo to match DS-7309 powder in bottle
DRUG	Metformin	Metformin 500mg tablet for Cohort F

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-10-08
• Last updated: 2014-11-24

Locations

1 site across 1 country: United States