NCT01964950

Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea

Nesina Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,101 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and sulfonylurea in participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy.

Detailed description

This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and sulfonylurea in participants with type 2 diabetes mellitus in a routine clinical setting. Participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy will be enrolled in this study. The planned sample size is 1,000. The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.

Conditions

• Surveillance

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-10-17
• Last updated: 2017-04-13
• Results posted: 2017-04-13

Locations

1 site across 1 country: Japan