CTRI/2013/11/004147
Other
Phase 4
Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy - STARCH AM
Bayer Zydus Pharma Private Ltd0 sites12,250 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Type 2 diabetic patients
- Sponsor
- Bayer Zydus Pharma Private Ltd
- Enrollment
- 12250
- Status
- Other
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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