NCT01993927

Voglibose Tablets 0.2 / OD Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"

Voglibose Tablets 0.2 / Voglibose Oral Disintegrant (OD) Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 742 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent progression to type 2 diabetes mellitus in participants with impaired glucose tolerance in the routine clinical setting.

Detailed description

This is a special drug use surveillance on long-term use of Voglibose (Basen) designed to determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent progression to type 2 diabetes mellitus in participants with impaired glucose tolerance in the routine clinical setting. Particioants will be patients with impaired glucose tolerance. The planned sample size is 1,000. The usual adult dosage is 0.2 mg of voglibose administered orally three times daily immediately before each meal.

Conditions

• Impaired Glucose Tolerance

Interventions

Type	Name	Description
DRUG	Voglibose	Voglibose Tablets / Voglibose OD Tablets

Timeline

• Start date: 2009-11-18
• Primary completion: 2013-08-31
• Completion: 2013-08-31
• First posted: 2013-11-25
• Last updated: 2018-12-04
• Results posted: 2018-11-02

Locations

1 site across 1 country: Japan