check_circleStudy Completed

Diabetes Mellitus

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