Diabetes Treatment With Glucobay in Combination With Metformin
- Registration Number
- NCT01612741
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19509
Inclusion Criteria
- All patient with type 2 diabetes with one of the following treatment ongoing : 1) Metformin 2) Metformin + OHA.
- In such patients, if investigator feels that addition of acarbose would be benficial for the patients
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Exclusion Criteria
- According to local product information
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Acarbose (Precose/Glucobay, BAYG5421) -
- Primary Outcome Measures
Name Time Method Data collection on pre treatment concomitant diseases 16 weeks Data collection on blood glucose 16 weeks Data collection on Hba1c 16 weeks Data collection on body weight 16 weeks
- Secondary Outcome Measures
Name Time Method Safety variables will be summarized using descriptive statistics based on adverse events collection 16 weeks