A clinical trial to study the safety and efficacy of 2mg and 4mg of ZYH1 compared to placebo in hypertriglyceridemia with type II diabetes not controlled with Atorvastatin therapy.[Prospective Randomised Efficacy and Safety of Saroglitazar (PRESS VI)].

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

1) Age 18- 65 years

2) Subjects of either gender, males or females

3) Subjects on treatment of type 2 diabetes mellitus (DM) for at least last 3 months or documented history of type 2 diabetes mellitus as per American Diabetes Association (ADA).

4) Patient on stable Atorvastatin therapy (10 mg) for at least 4 weeks with LDL greater than or equal to 100mg%.

5) Triglycerides > 200 up to 500 mg/dl on screening visit.

6) Body mass index (BMI) > 23 kg/m2

7) Subject has given informed consent for participation in this trial

Exclusion Criteria

1) Pregnancy and lactation
2) History of > 5% weight loss in past 6 months
3) Subjects on insulin
4) Subjects on glitazone / glitazar therapy in the past 1 month
5) Subjects having unstable angina, Acute Myocardial Infarction in past 3 months or heart failure of NYHA class (III-IV).
6) Uncontrolled hypertension
7) History of clinically significant edema.
8) History of thyroid disorder (abnormal TSH value) or subjects on any thyroid modulating drugs
9) History of active liver disease or gall stones or hepatic dysfunction demonstrated by AST and ALT greater than or equal to 2.5 times of upper normal limit (UNL) or bilirubin greater than or equal to 2 times UNL.
10) History of myopathies or evidence of active muscle diseases demonstrated by CPK greater than or equal 10 times UNL.
11) History of any other concurrent serious illness ( e.g. tuberculosis, HIV, malignancy)
12) History of alcohol and/or drug abuse
13) History of known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients.
14) Renal dysfunction demonstrated by abnormal serum creatinine levels (> 1.2 mg %) or presence of ketonuria.
15) Subjects on concomitant medications known to affect the lipid level other than Atorvastatin 10 mg in past 4 weeks.
16) History of contraceptive, hormone replacement therapy (HRT) or steroids since last 3 months.
17) History of long term use of Non steroidal anti- inflammatory drugs for any treatment such as osteoarthritis, rheumatoid arthritis etc.
18) Participation in any other clinical trial in the past 3 months
19) Unable to give informed consent.