Observational study to assess effectiveness of acarbose or metformin monotherapy in type 2 diabetic patient with respect to carbohydrate intake
- Conditions
- Health Condition 1: null- Type 2 diabetic patients
- Registration Number
- CTRI/2013/11/004147
- Lead Sponsor
- Bayer Zydus Pharma Private Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 12250
•Drug-naïve (i.e., the patients should never be treated with anti-diabetic drugs before screening) patients in whom decision to administer monotherapy with either acarbose or metformin for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and medical patient needs, and who consent to participate in study will be included
•Patients receiving any anti-diabetic medication at the time of enrollment in the study will be excluded. However, during observation period, patients may receive any additional anti-diabetics medication at the decision of investigator.
•Exclusion criteria should be read in conjunction with local product information. All contra-indications according to the local marketing authorization should be considered
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effectiveness of acarbose and metformin monotherapy,respectively,in terms of change in baseline in post prandial blood glucose level at the end of 16 weeks in drug naive type 2 diabetic patients within each carbohydrate consumption subgroup.Timepoint: Baseline and 16 weeks
- Secondary Outcome Measures
Name Time Method