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
Overview
- Phase
- Not Applicable
- Intervention
- Acarbose (Precose/Glucobay, BAYG5421)
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Bayer
- Enrollment
- 4564
- Primary Endpoint
- Data collection on Hba1c
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patient with type 2 diabetes with one of the following treatment ongoing : 1) Sulfonylurea 2) Sulfonylurea + OHA. In such patients, if investigator feels that addition of acarbose would be benficial for the patients
Exclusion Criteria
- •According to local product information
Arms & Interventions
Group 1
Intervention: Acarbose (Precose/Glucobay, BAYG5421)
Outcomes
Primary Outcomes
Data collection on Hba1c
Time Frame: 16 weeks
Data collection on body weight
Time Frame: 16 weeks
Data collection on blood glucose
Time Frame: 16 weeks
Data collection on pre treatment concomitant diseases
Time Frame: 16 weeks
Secondary Outcomes
- Safety variables will be summarized using descriptive statistics based on adverse events collection(16 weeks)