CTRI/2018/03/012842已完成4 期
Efficacy and safety of Hydroxychloroquine 300 mg as an add-on triple Drug in the Treatment of Type 2 Diabetes Mellitus Uncontrolled on Metformin and Glimepiride.
Dr Nihar Ranjan Bhattacharya0 个研究点目标入组 30 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
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Patients diagnosed of uncontrolled type 2 diabetes who are receiving treatment with OAD metformin 1000 mg/day and glimepiride 2mg/day are on stable dose for at least 12 weeks.
- •Patients with HbA1c >=7.0 % and <=9 %.
- •Patients with body weight >=60 kg.
- •Patients able to understand and willing to fully comply with study procedures and restrictions.
排除标准
- •Uncontrolled hyperglycemia i.e. FPG >240 mg/dL.
- •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 <20/100, abnormal visual fields, difficulty to examine optic disc, or evidence of retinal pigment epithelial abnormalities and patients with history or risk of macular edema.
- •Patients with recent ( <1 year) CV events i.e. myocardial infarction/ACS, 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.
- •Patient with known history of diabetic ketoacidosis Glucose-6-phophodehydrogenase deficiency Known allergy to the substance, and breastfeeding.
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