Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases
Conditions
Interventions
Intervention1: ASSESSING THE EFFECT OF GLIMEPIRIDE / METFORMIN / VILDAGLIPTIN/ DAPAGLIFLOZIN ON GLYCEMIC CONTROL
IN NOVEL SUBTYPES -
: In the SIDD (intervention arm) vildagliptin 50mg BD will be gi
Sponsors
USV Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. New onset of Type 2 diabetes (within 2 years of diagnosis) 2. Drug naive 3. Body Mass Index (BMI) � 40.0 kg/m2 4. HbA1c (Glycated Hemoglobin) � 7.0%
Exclusion criteria
Exclusion criteria: 1. Type 1 Diabetes 2. Use of any oral hypoglycemic agents or Insulin in past 3. Patients with a serum creatinine concentration greater than 132.6 mmol/L or liver function impairment 4. Significant alcohol, drug, or medication abuse 5. Currently under psychiatric care or using antipsychotic or mood stabilizer medication or diagnosed to have dementia or bipolar disorder or schizophrenia 6. History of anemia or hemoglobinopathy and/ or hemoglobin 7. Pregnant or lactating women 8. Documented CVD event in past 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c between assigned treatment and control groupsTimepoint: From baseline to week 12 and 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in BMITimepoint: From baseline to 12 and 24 weeks;Change in CGM profileTimepoint: From baseline to week 24;Change in FPG and 2-hour PPG levelsTimepoint: From baseline to 12 and 24 weeks;Change in HOMA - BTimepoint: From baseline to week 24;Change in HOMA - IRTimepoint: From baseline to week 24;Change in Lipid profileTimepoint: From baseline to week 24 | — |
Countries
India
Contacts
Public ContactDr V Mohan
Madras Diabetes Research Foundation
Outcome results
None listed