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Prospecitve, Non Interventional, Non Controlled, Post Marketing Survelliance Study to Evaluate Efficacy, Safety, Tolerability of Glucobay on Top of Sulfonylurea Under Daily Life Treatment Conditions
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 sulfonylurea 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 sulfonylurea therapy.The study is planned to carried out in 25000 - 30000 patients from 200 trial sites in India.The Post Marketing Survelliance 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.
Details
| Lead sponsor | Bayer |
|---|---|
| Status | COMPLETED |
| Enrolment | 4564 |
| Start date | 2008-04 |
| Completion | 2008-12 |
Conditions
- Type 2 Diabetes Mellitus
Interventions
- Acarbose (Precose/Glucobay, BAYG5421)
Primary outcomes
- Data collection on body weight — 16 weeks
- Data collection on blood glucose — 16 weeks
- Data collection on Hba1c — 16 weeks
- Data collection on pre treatment concomitant diseases — 16 weeks
Countries
India