Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: The percentage reduction of triglyceride levels and glycemic profile: at baseline, 6th week and 12 th week after allocation of treatment
Control Intervention1: Tablet Saroglitazar 4mg O
Sponsors
Endolife Specialty Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults of either sex 2. Aged between 18 and 65 years, who had received dietary and exercise counselling for 12 weeks 3. Newly diagnosed / previous history of Diabetic dyslipidemia/ treatment with atorvastatin 10mg for at least 4 weeks/ TG is not controlled with non-pharmacological therapy with plasma triglyceride level >= 200 mg/dl and = 100 mg/dL; and HbA1C >= 7 and 4. Previous treatments with a maximum of two oral hypoglycaemic agents/ only metformin 1000 mg per day. 5. Body mass index >23 kg/m2
Exclusion criteria
Exclusion criteria: 1. Female patients who are pregnant or lactating 2. Fasting plasma glucose (FPG) > 250mg/dl, post-prandial plasma glucose (PPPG) > 350mg/dl 3. LDL-C > 130 mg/dl, co-morbid cardiovascular, renal and psychiatric complications, co-administration of drugs that were likely to interact with saroglitazar, fenofibrate or metformin and that are likely to alter lipid profile and glycaemic status. 4. Subjects were excluded if they had been treated within 4 weeks of the run-in period with oral antidiabetes drugs from the glitazone (e.g., pioglitazone or rosiglitazone) and glitazar (investigational products) and SGLT2 inhibitors (canagliflozin, dapagliflozin, and empagliflozin) classes, insulin, lipid-modifying therapy (e.g., fenofibrate) other than atorvastatin 10 mg, thyroid-modulating drug, or anti-inflammatory drugs. 5. None of the patients received any hypolipidaemic agent within last six months 6. Unstable angina, acute myocardial infarction in the preceding 3 months, heart failure classified as New York Heart Association Class IIIâ??IV, uncontrolled hypertension, clinically significant edema, thyroid disorder. 7. Gallstones, impaired liver (aspartate ami no transferase and alanine aminotransferase >=2.5 times the upper normal limit [UNL] or bilirubin >=2 times the UNL) or renal (serum creatinine >1.2 mg/dL) function, ketonuria, myopathies or active muscle diseases (creatinine phosphokinase [CPK] >= 10 times UNL). 8. Severe illness such as tuberculosis, human immunodeficiency infection, malignancy 9. Alcohol and/or drug abuse, allergy, sensitivity or intolerance to the study drugs and their formulation ingredients, and participation in any other clinical trial in the preceding 3 months at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The percentage reduction of triglyceride levels increase of HDL levels 2. Improvement of glycemic profile (HbA1C, FBG ) and insulin resistance (HOMA-IR) Timepoint: At Baseline (0 week), 6th week and 12th week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the percentage change of body weight 2. To evaluate the percentage change of body fat, muscle and water contentsTimepoint: At Baseline (0 week), 6th week and 12th week | — |
Countries
India
Contacts
Public ContactRANAKISHOR PELLURI
Endolife Speciality Hospital Pvt. Ltd
Outcome results
None listed