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临床试验/CTRI/2018/03/012842
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.

研究者

发起方
Dr Nihar Ranjan Bhattacharya

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