Trial Condition(s):
Diabetes Mellitus
Special Drug Use Investigation of Glucobay OD
Bayer Identifier:
16517
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
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
Phase
N/A
Could I receive a placebo?
No
Products
Glucobay ODT (Acarbose, BAYG5421)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs)Timeframe: Up to 1 year
- Decrease rate of HbA1cTimeframe: Up to 1 year
Secondary Outcome
- Body weightTimeframe: up to1 year
Additional Information
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