Assessing the differential benefits of various anti diabetic agents among individuals with novel subtypes of diabetes
Phase 4
- Conditions
- Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases
- Registration Number
- CTRI/2021/11/037753
- Lead Sponsor
- SV Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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 < 10 g/dL for men , <9 g/dL for women
7. Pregnant or lactating women
8. Documented CVD event in past 12 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c between assigned treatment and control groupsTimepoint: From baseline to week 12 and 24
- Secondary Outcome Measures
Name Time Method 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