NCT01026194

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (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 efficacy and safety of MP-513 (Teneligliptin) in combination with thiazolidinedione (pioglitazone) in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with thiazolidinedione with an extension treatment for up to 52 weeks.

Conditions

• Type 2 Diabetes Mellitus

Interventions

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

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-12-04
• Last updated: 2026-01-05
• Results posted: 2013-10-28

Locations

1 site across 1 country: Japan