Special Drug Use Investigation of Glucobay OD

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Glucobay ODT (Acarbose, BAYG5421)

• Registration Number: NCT01685502
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-14
• Primary Completion: 2013-09
• Study Completion: 2014-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-17
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2289

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.

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Exclusion Criteria

• Patients who are contraindicated based on the product label

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Glucobay ODT (Acarbose, BAYG5421)	Patients treated with Glucobay OD under practical manner

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Body weight	up to1 year