check_circleStudy Completed
Type 2 Diabetes Mellitus
Bayer Identifier:
13925
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Diabetes treatment with Glucobay in combination with metformin
Trial purpose
In this prospective, non interventional, observational Post Marketing Survelliance study data are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of metformin under daily life treatment conditions.Specifically investigated is the influence of Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when added to an already existing metformin therapy.The study is planned to carried out in 25000 - 30000 patients from 200 trial sites in India.The PMS study will be performed with commercially available medication prescribed within regular practice of the physician. No other examination will be performed than would be done without Post Marketing Survelliance study.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
19509Trial Dates
April 2008 - January 2009Phase
N/ACould I Receive a placebo
NoProducts
Acarbose (Precose/Glucobay, BAYG5421)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, India |
Primary Outcome
- Data collection on body weightdate_rangeTime Frame:16 weeksenhanced_encryptionNoSafety Issue:
- Data collection on blood glucosedate_rangeTime Frame:16 weeksenhanced_encryptionNoSafety Issue:
- Data collection on Hba1cdate_rangeTime Frame:16 weeksenhanced_encryptionNoSafety Issue:
- Data collection on pre treatment concomitant diseasesdate_rangeTime Frame:16 weeksenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Safety variables will be summarized using descriptive statistics based on adverse events collectiondate_rangeTime Frame:16 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A