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NCT01685502 Clinical Trial

Special Drug Use Investigation of Glucobay OD

Diabetes Mellitus Clinical Trial

Official title:
Special Drug Use Investigation of Glucobay OD

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01685502
Other study ID # 16517
Secondary ID Glucobay OD
Status Completed
Phase N/A
First received September 12, 2012
Last updated October 17, 2014
Start date November 2010
Est. completion date August 2014

Study information
Verified date October 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2289
Est. completion date August 2014
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Glucobay ODT (Acarbose, BAYG5421)
Patients treated with Glucobay OD under practical manner

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs) Up to 1 year Yes
Primary Decrease rate of HbA1c Up to 1 year No
Secondary Body weight up to1 year No
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