Health Condition 1: R730- Abnormal glucose
Conditions
Interventions
Intervention1: Atorvastatin tablet 20 mg: Pre diabetic patients with dyslipidemia
Control Intervention1: Hydroxycholoroquine 300 mg with Atorvastatin 20 mg: Pre diabetic patient with dyslipidemia
Sponsors
Ipca Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients with primary dyslipidemia (LDL-C level >= 130 mg/dL and/or TG levels >=150 mg/dL and 2) Patients having HbA1c between 5.7% and 6.4% 3) Patients with body weight > 60 kg 4) Patients able to understand and willing to fully comply with study procedures and restrictions 5) Patient ready to give written informed consent as per applicable regulatory requirements
Exclusion criteria
Exclusion criteria: 1) Patients with Type 1 or Type 2 diabetes 2) Patients with a history or presence of any retinopathy of any grade including diabetic retinopathy requiring laser therapy, evidence of an imminent need for retinal laser therapy, uncorrected visual acuity examine optic disc, or evidence of retinal pigment epithelial abnormalities and patients with history or risk of macular edema 3) Patients with abnormal renal function (eGFR 4) Patients with abnormal liver function (AST and ALT, total bilirubin, creatine phosphokinase or alkaline phosphatase >2.5 times the upper limit of normal values) 5) Patients with cardiovascular accident or myocardial infarction, stroke or has undergone coronary artery bypass surgery, percutaneous transluminal coronary angioplasty or transient ischemic attack, or history of congestive heart failure, or unstable angina or edema of any type in past 6) Patients with history of myalgia, aplastic anemia or agranulocytosis, granulocytopenia, psoriasis, porphyria, rash, scaling, scaling eczema, and G6PD deficiency 7) Patient with history of symptomatic autonomic neuropathy 8) Patients with disease of blood or haematopoetic organs or hemoglobin female patient or hemoglobin 9) Patients with systolic BP > 180 mm Hg and/or diastolic BP >110 mmHg 10) Patients with chronic gastroparesis, active gastrointestinal disorders (gastric and duodenal ulcer) 11) Patient who had any other illness for which hydroxychloroquine was indicated (such as rheumatoid arthritis, SLE). 12) Patients with known history of HIV1/HIV2/Hepatitis B or C infection or syphilis infection 13) Patients with any other clinically significant abnormality (ies) interfering with disease under evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients developing diabetes (HbA1c â?¥ 6.5%)Timepoint: Within 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C) and non-high density lipoprotein cholesterol (non-HDL-C)Timepoint: At week 24 and week 52 | — |
Countries
India
Contacts
Public ContactDr Ravi Mehta
Ipca Laboratories Ltd.
Outcome results
None listed