Study Completed

Diabetes Mellitus

Bayer Identifier:

16517

ClinicalTrials.gov Identifier:

NCT01685502

EudraCT Number:

Not Available

EU CT Number:

Not Available

Special Drug Use Investigation of Glucobay OD

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

0 - N/A

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

Trial summary

Enrollment Goal

2289

Trial Dates

November 2010 - August 2014

Phase

N/A

Could I Receive a placebo

Products

Glucobay ODT (Acarbose, BAYG5421)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Japan

Primary Outcome

Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs)
Time Frame:
Up to 1 year
Safety Issue:
Yes
Decrease rate of HbA1c
Time Frame:
Up to 1 year
Safety Issue:
No

Secondary Outcome

Body weight
Time Frame:
up to1 year
Safety Issue:
No

Trial design

Special Drug Use Investigation of Glucobay OD

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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