NCT01154348

Study to Assess Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus

A Phase 1b, Randomized, Placebo-Controlled Study to Assess the Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and pharmacokinetics of double-blind S-707106 alone and in combination with open-label metformin in patients with type 2 diabetes mellitus

Detailed description

Safety will be evaluated by monitoring of treatment-emergent adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiograms, 24-hour telemetry monitoring, and physical exams. Specific study withdrawal criteria during washout periods of metformin have been established for loss of glycemic control, i.e., glucose monitoring. Pharmacokinetic assessments of monotherapy cohort versus add-on therapy will be performed

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	S-707106	Tablet, taken once daily with morning meal
DRUG	Placebo	Placebo tablet, taken once daily with morning meal
DRUG	Metformin, S-707106 plus metformin	Metformin twice daily maintenance, S-707106 tablet taken once daily with morning meal with metformin dosed twice daily
DRUG	Metformin, placebo plus metformin	Metformin twice daily maintenance, placebo tablet taken once daily with morning meal with metformin twice daily

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-11-01
• Completion: 2010-12-01
• First posted: 2010-06-30
• Last updated: 2018-04-27

Locations

1 site across 1 country: United States