check_circleStudy 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
  • - Glucobay OD naive diabetics. patients with at least one of the following conditions: Uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin therapy.
  • - 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
No
Products
Glucobay ODT (Acarbose, BAYG5421)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

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

Secondary Outcome

  • Body weight
    date_rangeTime Frame:
    up to1 year
    enhanced_encryption
    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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