Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: SAROGLITAZAR: SAROGLITAZAR is a dual PPAR alpha/gamma agonist used in T2DM
4mg once daily for 3 months
Control Intervention1: Placebo: Placebo once daily for 3 months
Sponsors
AIIMS Jodhpur
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18 â?? 65yr. 2.Diagnosis of type 2 diabetes mellitus as per ADA criteria. 3.On lifestyle modifications and on metformin; vildagliptin medications for 3 months. 4.HbA1C >7%
Exclusion criteria
Exclusion criteria: 1.Patient who had any clinically significant or unstable medical or Psychiatric illness. 2.History of cardiac diseases (NYHA grade 3 â?? 4) or cardiac anomalies. 3.Patient on glitazone/glitazar for >30days. 4.History of Renal insufficiency - serum creatinine >=1.8mg/dl. 5.Patient with history of significant hepatic impairment (serum bilirubin >2 times, AST, ALT and alkaline phosphatase >3 times the upper limit of normal). 6.Patient have history of uncontrolled hypertension. 7.Patient have any malignancy and Patient have any h/o substance abuse (alcohol/drugs). 8.Pregnant & Lactating Woman and Patient with history of allergy/intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effect of Saroglitazar versus placebo in terms of HbA1c values in T2DM.Timepoint: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the effect on lipid profile parameters of Saroglitazar versus placebo in T2DM. 2.To evaluate the effect on HOMA index of Saroglitazar versus placebo in T2DM. 3.To evaluate the effect on Metabolic syndrome parameters of Saroglitazar versus placebo in T2DM. 4.To evaluate the effect on QOL score of Saroglitazar versus placebo in T2DM. 5.To evaluate the safety of Saroglitazar versus placebo in T2DM. Timepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactSachin J
AIIMS Jodhpur
Outcome results
None listed