NCT00974090

Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes

A Phase III Study of MP-513 in Combination With Sulfonylurea in Japanese Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) in combination with Sulfonylurea in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Sulfonylurea with an extension treatment for up to 52 weeks.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea)	Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea
DRUG	Teneli / Teneli + SU	Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-09-10
• Last updated: 2026-01-05
• Results posted: 2014-05-08

Locations

1 site across 1 country: Japan