CTRI/2021/03/031900尚未招募3 期
A prospective, Randomized, open-label, study to evaluate safety and efficacy of Saroglitazar and Fenofibrate add-on therapy with oral hypoglycemic agents in Indian Type-2 diabetic dyslipidaemic patients
Endolife Specialty Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Adults of either sex
- •2. Aged between 18 and 65 years, who had received dietary and exercise counselling for 12 weeks
- •3. Newly diagnosed / previous history of Diabetic dyslipidemia/ treatment with atorvastatin 10mg for at least 4 weeks/ TG is not controlled with non-pharmacological therapy with plasma triglyceride level >= 200 mg/dl and <500 mg/dL; Low-density lipoprotein cholesterol (LDL-C) level >= 100 mg/dL; and HbA1C >= 7 and <= 9%
- •4. Previous treatments with a maximum of two oral hypoglycaemic agents/ only metformin 1000 mg per day.
- •5. Body mass index >23 kg/m2
排除标准
- •1. Female patients who are pregnant or lactating
- •2. Fasting plasma glucose (FPG) > 250mg/dl, post-prandial plasma glucose (PPPG) > 350mg/dl
- •3. LDL-C > 130 mg/dl, co-morbid cardiovascular, renal and psychiatric complications, co-administration of drugs that were likely to interact with saroglitazar, fenofibrate or metformin and that are likely to alter lipid profile and glycaemic status.
- •4. Subjects were excluded if they had been treated within 4 weeks of the run-in period with oral antidiabetes drugs from the glitazone (e.g., pioglitazone or rosiglitazone) and glitazar (investigational products) and SGLT2 inhibitors (canagliflozin, dapagliflozin, and empagliflozin) classes, insulin, lipid-modifying therapy (e.g., fenofibrate) other than atorvastatin 10 mg, thyroid-modulating drug, or anti-inflammatory drugs.
- •5. None of the patients received any hypolipidaemic agent within last six months
- •6. Unstable angina, acute myocardial infarction in the preceding 3 months, heart failure classified as New York Heart Association Class IIIâ??IV, uncontrolled hypertension, clinically significant edema, thyroid disorder.
- •7. Gallstones, impaired liver (aspartate ami
- •no transferase and alanine aminotransferase >=2.5 times the upper normal limit [UNL] or bilirubin >=2 times the UNL) or renal (serum creatinine >1.2 mg/dL) function, ketonuria, myopathies or active muscle diseases (creatinine phosphokinase [CPK] >= 10 times UNL).
- •8. Severe illness such as tuberculosis, human immunodeficiency infection, malignancy
- •9. Alcohol and/or drug abuse, allergy, sensitivity or intolerance to the study drugs and their formulation ingredients, and participation in any other clinical trial in the preceding 3 months at the time of enrollment.
研究者
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