CTRI/2016/08/007126已完成4 期
A prospective, multicentric, single arm clinical study to evaluate the effect of saroGlitazar on non HDL-ChoLesterol in patIents with Diabetic Dyslipidaemia inadequately controllEd with diet, exeRcise and statin.(Glidder) - GLIDDER
Dr Upendra Kaul0 个研究点目标入组 104 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Type 2 Diabetes Mellitus patients (as per ADA 2015 criteria) age above 18 years, inclusive of either sex
- •2.Patients with triglyceride >=200 mg/dL after diet, exercise and stable statin therapy for at least 3 months
- •3.Patient with ability to understand and provide written informed consent form, which must have been obtained prior to study procedure
- •4.Patients willing to comply with the protocol requirements.
排除标准
- •1.Known cases of type 1 diabetes mellitus
- •2.Diabetic complications such as diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycaemia hyperosmolar state, retinopathy, neuropathy or other diabetic complications of sufficient severity to require treatment like severe peripheral neuropathy, foot ulcers, gastric stasis
- •3.Uncontrolled hypertension and its complications such as malignant hypertension, resistant hypertension
- •4.Urinary retention
- •5.History of >=5% weight change due to unknown reason in the preceding 6 months
- •6.History of unstable angina, acute myocardial infarction in the preceding 3 months, heart failure classified as New York Heart Association Class IIIâ??IV, Patients with history of arrhythmias, Torsades de pointes or using antiarrhythmic drugs, patients with edema suggestive of cardiac involvement.
- •7.Patients receiving glitazones, insulin, lipid-modifying therapy (e.g., fenofibrate) other than statin or glitazar
- •8.Uncontrolled thyroid disorders
- •9.Patients having gallstones
- •10.Patients having impaired liver (aspartate aminotransferase and alanine aminotransferase â?¡2.5 times the upper normal limit [UNL] or bilirubin â?¡2 times the UNL)
- •11.Patients having renal (serum creatinine 1.5 mg/dL) function, ketonuria
- •12.Patients having myopathies or active muscle diseases (creatinine phosphokinase [CPK] ±10 times UNL)
- •13.Patients having severe illness such as tuberculosis, human immunodeficiency infection & malignancy
- •14.Patients with continuing history of alcohol and / or drug abuse
- •15.Patients having allergy, sensitivity or intolerance to the study drugs and their formulation ingredients
- •16.Patients who have participated in any other clinical trial in the preceding 3 months at the time of enrolment.
- •17.Female subjects were excluded if they were pregnant or breast feeding or had initiated hormonal treatment (e.g., hormonal contraceptive, hormone replacement therapy) in the preceding 3 months.
- •18.Any other condition that in the opinion of the Investigator that does not justify the patientâ??s participation in the study.
研究者
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