Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Control Intervention1: NIL: NIL
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults (greater than 18 years) of either gender 2. Subjects with known T2DM (Random plasma glucose greater than or equal to 200 mg per dl or fasting plasma glucose greater than or equal to 126 mg per dl or HbA1c greater than or equal to 6.5 percent or on antidiabetic therapy) for at least 3 months 3. Subjects willing to provide informed consent and comply with study procedures
Exclusion criteria
Exclusion criteria: 1. Subjects with known Diabetes Mellitus (DM) other than T2DM (Type 1 Diabetes Mellitus, maturity onset of Diabetes in young, Latent Autoimmune Diabetes in Adults) 2. Subjects with known T2DM and documented evidence of CKD and HF 3. Subjects with acute renal insufficiency or non-diabetic kidney disease (NDKD) or those on renal replacement therapy 4. Subjects with malignancy or other severe life-threatening conditions affecting study participation 5. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with CKD, assessed using UACR and or eGFR at baseline and 3 months [UACR greater than or equal to 30 mg per g and or eGFR less than 60 ml per min per 1.73 m2 at baseline and 3 months]Timepoint: Baseline, 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects at risk of HF, assessed by NT-proBNP levels of greater than 125 pg/mL at baselineTimepoint: Baseline;Proportion of subjects with CKD stratified based on demographics (age, gender, BMI, duration of T2DM), and comorbiditiesTimepoint: Baseline;Proportion of subjects at risk of HF stratified based on demographics (age, gender, BMI, duration of T2DM), and comorbiditiesTimepoint: Baseline;Proportion of subjects with CKD risk categories (Low risk, moderately increased risk, high risk and very high risk) using 2024 Kidney Disease: Improving Global Outcomes (KDIGO) staging matrix of CKD at 3 monthsTimepoint: 3 months;Incidence of major adverse cardiovascular events (MACE) during 6 months [MACE is defined as composite of non-fatal myocardial infarction (MI), non-fatal stroke, cardiovascular death, unstable angina, hospitalization because of HF]Timepoint: 3 months, 6 months;Proportion of subjects with major adverse cardiovascular events (MACE) during the 6 months study periodTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactMs Colette Pinto
Sun Pharma Laboratories Limited
Outcome results
None listed