NCT01240759

Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of S-707106 co-administered with metformin in subjects with type 2 diabetes mellitus.

Detailed description

Based on the unmet clinical need for more safe and effective type 2 diabetes mellitus therapies, together with the nonclinical efficacy and safety profile of S-707106, Shionogi USA, Inc. is initiating studies to further assess the efficacy, clinical pharmacology and safety profile of S-707106 in preparation for full clinical development as a novel treatment for type 2 diabetes mellitus. It is anticipated that S-707106 will provide clinicians and patients with a new therapeutic option to treat type 2 diabetes mellitus with potential advantages over existing therapy.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	S-707106 Dose A	One S-707106 A tablet
DRUG	S-707106 Dose B	One S-707106 B tablet
DRUG	S-707106 Dose C	Four S-707106 4 X B tablets
DRUG	Placebo A tablet	Up to 4 Placebo A tablets
DRUG	Metformin	The standard of care dose of metformin for each patient

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2010-11-15
• Last updated: 2018-05-15

Locations

1 site across 1 country: United States