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Special Drug Use Investigation of Glucobay OD
The objective of this study is to assess the efficacy and safety under practical use of Glucobay OD. A total of 5,000 patients are to be enrolled to the study and assessed during 1 year observation period.
Details
| Lead sponsor | Bayer |
|---|---|
| Status | COMPLETED |
| Enrolment | 2289 |
| Start date | 2010-11 |
| Completion | 2014-08 |
Conditions
- Diabetes Mellitus
Interventions
- Glucobay ODT (Acarbose, BAYG5421)
Primary outcomes
- Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs) — Up to 1 year
- Decrease rate of HbA1c — Up to 1 year
Countries
Japan