Drug trial between new drug Saroglitazar with existing drug Fenofibrate in patients with diabetes

Not Applicable

Completed

Conditions: Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Registration Number: CTRI/2019/02/017410

Lead Sponsor: Maulana azad medical college

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Diagnosed patients of diabetic dyslipidemia with (fasting TG > 200 to 400 mg/dL)

2. Patients in the age group of 18 to 65 years,

3.Patients with history of type 2 diabetes mellitus (glycosylated hemoglobin [HbA1c]

>7% to 9%),

4.Patients being treated with either a sulphonylurea, metformin for diabetes, or both treatments for at least 3 months.

5.Patients being treated with Atorvastatin 10mg tablet for at least 4 weeks.

Exclusion Criteria

1.Patients on insulin, glitazone or glitazar, or medications with a lipid-lowering agent in

past 2 weeks.

2.Patients who had a history of cardiac abnormalities (myocardial infarction, coronary

artery bypass graft, percutaneous transluminal coronary angioplasty,unstable angina or

heart failure, hypertension ( >150/100 mmHg).

3. Patients with thyroid dysfunction.

4. Patients having hepatic dysfunction (aspartate aminotransferase/alanine aminotransferase Ã¢â?°Â¥2.5 times of upper normal limit [UNL] or bilirubin > 2 times of UNL).

5. Patients with renal dysfunction (serum creatinine >1.2 mg/dL).

6. Patients with Comorbid serious illness such as tuberculosis, HIV, Malignancy.

7. Patients on Alcohol or drug abuse.

8. Patients allergic to the study medications

9. Pregnant female patients and nursing mothers were also be excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absolute changes in serum triglyceride level at baseline and at end of treatment period.Timepoint: At baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Changes from baseline lipids HDL-C (high density lipoprotein-cholesterol), LDL-C(low density lipoprotein-cholesterol), Total Cholesterol, VLDL-C(very low density lipoprotein-cholesterol), FBG and HbA1c profile at the end of treatment period. <br/ ><br> <br/ ><br>2. Safety assessment during the duration of therapy.Timepoint: At baseline and at 12 weeks