check_circleStudy Completed
Diabetes Mellitus
Bayer Identifier:
16517
ClinicalTrials.gov Identifier:
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
BothAge
0 - N/ATrial summary
Enrollment Goal
2289Trial Dates
November 2010 - August 2014Phase
N/ACould I Receive a placebo
NoProducts
Glucobay ODT (Acarbose, BAYG5421)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Japan |
Primary Outcome
- Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs)date_rangeTime Frame:Up to 1 yearenhanced_encryptionYesSafety Issue:
- Decrease rate of HbA1cdate_rangeTime Frame:Up to 1 yearenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Body weightdate_rangeTime Frame:up to1 yearenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A