Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Type-2, Acarbose, Drug Therapy, Combination
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.
Interventions
Oral Glucobay 25 titrated to Glucobay 50 upto three times a day with meals or as per investigators descretion.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Safety variables will be summarized using descriptive statistics based on adverse events collection | 16 weeks |
Countries
India
Outcome results
None listed