Diabetes Treatment With Glucobay in Combination With Metformin
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospecitve, Non Interventional, Non Controlled, Post Marketing Survelliance Study to Evaluate Efficacy, Safety, Tolerability of Glucobay M on Top of Metformin Under Daily Life Treatment Conditions|
- Data collection on body weight [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Data collection on blood glucose [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Data collection on Hba1c [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Data collection on pre treatment concomitant diseases [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2008|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Drug: Acarbose (Precose/Glucobay, BAYG5421)
Oral Glucobay 25 titrated to Glucobay 50 three times a day with meals or as per investigators descretion.