Special Drug Use Investigation of Glucobay OD

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01685502

Enrollment

2289

Registered

2012-09-14

Start date

2010-11-30

Completion date

2014-08-31

Last updated

2014-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Glucobay OD, Diabetes Mellitus

Brief summary

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.

Interventions

DRUGGlucobay ODT (Acarbose, BAYG5421)

Patients treated with Glucobay OD under practical manner

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Glucobay OD naive diabetics. patients with at least one of the following conditions: Uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin therapy.

Exclusion criteria

* Patients who are contraindicated based on the product label

Design outcomes

Primary

Measure	Time frame
Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs)	Up to 1 year
Decrease rate of HbA1c	Up to 1 year

Secondary

Measure	Time frame
Body weight	up to1 year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026