Voglibose v/s Glimepiride Efficacy and Safety in Combination with Metformin in Type-2 Diabetes Mellitus patients
Not Applicable
Completed
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2021/04/033005
- Lead Sponsor
- AIIMS JODHPUR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 73
Inclusion Criteria
1. NEWLY DIAGNOSED T2-DM WITH HbA1c between 7-11% or,
2. T2-DM PATIENT UNCONTROLLED ON METFORMIN 500MG BD (RBS >200 ON ATLEAST 3 OCASSIONS OR HbA1c between 7-11%).
Exclusion Criteria
1. Type-1 DM PATIENTS
2. PREGNANCY & LACTATING WOMEN
3. PATIENTS WITH HEART FAILURE (NYHA CLASS 2-4)
4. PATIENTS WITH HISTORY OF CHRONIC KIDNEY
DISEASE (SERUM CREATININE > 1.5mg/dl)
5. PATINETS WITH HISTORY OF LIVER FAILURE
6. PATIENTS WITH HISTORY OF AUTOIMMUNE DISORDERS
7. PATIENTS WITH HISTORY OF COPD.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Difference of HbA1c reduction in between voglibose and glimepiride group after 3 months <br/ ><br>2. Difference in decrease in FBS and PPBS between voglibose and glimepiride group after 3 monthsTimepoint: Baseline and after 1 and 2 and 3 months of treatment
- Secondary Outcome Measures
Name Time Method 1. Adverse events in both the groups. <br/ ><br>2. Difference in lipid parameters (Triglycerides, Total Cholesterol, LDL, VLDL, and HDL) in both the groups after 3 months. <br/ ><br>3. Difference in quality-of-life indicators between voglibose and glimepiride group after 3 months. <br/ ><br>4. Difference in HOMA â?? IR, HOMA â?? β% and HOMA-S% of voglibose and glimepiride group after 3 months <br/ ><br>5. Difference in need and use of rescue medicines in both the groups during 3month study period.Timepoint: Baseline and after 1 and 2 and 3 months of treatment