NCT01042106

Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults

A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Oral Dose Study to Evaulate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Type 2 Diabetic and Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes mellitus and healthy adults.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	DSP-8658	Ascending doses of DSP-8658 - 2.5, 10, 20, 40 mg orally once daily
DRUG	Placebo	Placebo 2.5, 10, 20, 40 mg orally once daily

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-01-05
• Last updated: 2013-09-16

Locations

1 site across 1 country: United States