A clinical trial to study the effects of two drugs,ZYH1 and Rosiglitazone in diabetic patients with high lipid levels.[Prospective Randomised Efficacy and Safety of Saroglitazar (PRESS II)]

A 12 week, randomised, double blind parallel group prospective dose ranging study of ZYH1 with an open Rosiglitazone arm to evaluate the efficacy on dyslipidemia in patients with diabetes - NA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000165

Enrollment

Registered

2010-03-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Dyslipidemia with Diabetes Health Condition 2: E785- Hyperlipidemia, unspecified

Interventions

Intervention1: ZYH1 0.5mg, 1mg, 2mg and 4mg: one tablet once daily of either 0.5mg, 1mg, 2mg or 4mg in the morning for the entire duration of the study i.e. for 12 weeks Control Intervention1: Rosigli

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of either sex > or =18 years of age. 2.Established diagnosis of dyslipidemia with BMI 23-42kg/m2 with fasting triglyceride level > or = 150mg/dL. 3.Established diagnosis of Type 2 Diabetes Mellitus with Fasting Blood glucose > or = 126mg/dL (According to American Diabetes Association) with or without on treatment with other hypoglycemic drugs. 4.Normal routine hematological and biochemical test results. 5.Informed consent of the patient / relative.

Exclusion criteria

Exclusion criteria: 1.Hypersensitivity to sulpha drugs or ZYH1. 2.Pregnancy & Lactation. 3.Patients with active liver disease or hepatic dysfunction indicated by AST or ALT levels  2.5 times the upper limit of normal. 4.Patients with history of myopathy or evidence of active muscle disease. 5.Haemoglobin less than 11mg% 6.Patients on concomitant medications known to affect lipid levels and glucose levels and do not want to enter in wash out period. 7.Patients with any other serious concurrent illness or malignancy. 8.Presence or history of gallstone. 9.Patients with continuing history of alcohol and / or drug abuse. 10.Participation in another clinical trial in the past 3 months

Design outcomes

Primary

Measure	Time frame
Primary efficacy endpoints: 1.Triglyceride 2.Low density Lipoproteins ( LDL) cholesterol, 3.Very low density lipoprotein (VLDL) cholesterol, 4.HDL cholesterol and 5.Fasting Glucose.Timepoint: From baseline, visit 2(Week 0)to visit 8 (Week 12)	—

Secondary

Measure	Time frame
Secondary efficacy endpoints: 1.HbA1C, 2.Insulin and 3.C-Reactive protein(CRP)Timepoint: From baseline, visit 2 (Week 0)to visit 8 (Week 12)	—

Countries

India

Contacts

Public ContactDr RH Jani

Cadila Healthcare Limited

rhjani@zyduscadila.com91-22-26186052

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026