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)]
- Conditions
- Hyperlipidemia, unspecified,
- Registration Number
- CTRI/2010/091/000165
- Lead Sponsor
- Cadila Healthcare Limited
- Brief Summary
This was a a 12 week, randomized, double blind, parallel group, prospective, dose ranging, and comparative study of ZYH1 with an open Rosiglitazone arm to evaluate the efficacy and safety of oral 0.5, 1, 2 and 4mg ZYH1 as compared to the highest recommended dose of Rosiglitazone ( 8/16 mg daily) on lipid profile and glycemic control in patients suffering from dyslipidemia with diabetes mellitus.The 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. The Secondary efficacy endpoints: 1.HbA1C, 2.Insulin and 3.C-Reactive protein(CRP) The efficacy variables were assessed as percent change at the end of treatment phase i.e., Week 12, as compared to start of treatment phase i.e., Week 0
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. From baseline, visit 2(Week 0)to visit 8 (Week 12)
- Secondary Outcome Measures
Name Time Method Secondary efficacy endpoints: 1.HbA1C, 2.Insulin and 3.C-Reactive protein(CRP) From baseline, visit 2 (Week 0)to visit 8 (Week 12)
Trial Locations
- Locations (2)
Institute of Postgraduate Medical Education & Research (IPGMER)
🇮🇳Kolkata, WEST BENGAL, India
Post-Graduate Institute of Medical Education & Research (PGIMER)
🇮🇳Chandigarh, CHANDIGARH, India
Institute of Postgraduate Medical Education & Research (IPGMER)🇮🇳Kolkata, WEST BENGAL, IndiaDr. Satinath MukherjeePrincipal investigator09830027985satinath.mukhopadhyay@gmail.com