NCT01964976

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,096 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and biguanides in participants with type 2 diabetes mellitus who responded inadequately to treatment with biguanides 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 biguanides in participants with type 2 diabetes mellitus in the routine clinical setting. Participants diagnosed with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy will be enrolled. 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