prospective comparison of safety , efficacy and cost effectiveness of various treatment regimen in type 2 diabetes mellitus
Phase 4
Completed
- Conditions
- Health Condition 1: null- Type 2 diabetes mellitus
- Registration Number
- CTRI/2014/02/004435
- Lead Sponsor
- Vardhman Mahavir Medical college and Safdarjung Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
type 2 diabetes mellitus either newly diagnosed or previously established with baseline HbA1c >=7%
- not controlled by metformin alone needing additional antihyperglycaemic drugs
- willing to provide written informed consent
Exclusion Criteria
- patients of type 1 diabetes,
- patients on insulin treatment
- secondary diabetes
- complications on or during treatment plan
- known or suspected hypersensitivity to study drugs
- co-morbid illness like cardiovascular diseases, renal failure or liver diseases
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change in HbA1c levelTimepoint: day 0 and at end of 3 months
- Secondary Outcome Measures
Name Time Method Cost effectivenessTimepoint: at end of 3 months;fasting plasma glucoseTimepoint: day 0, week 2, 1st month, 2nd month and 3rd month;Postprandial glucoseTimepoint: day 0, week 2, 1st month, 2nd month and 3rd month