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临床试验/CTRI/2016/02/006599
CTRI/2016/02/006599招募中4 期

Evaluation of Safety and Efficacy of Hydroxychloroquine Sulfate as an Adjunct to Diet and Exercise to Improve Glycemic Controll in Type-2 Diabetes Patients Uncontrolled on Sulfonylurea and Metformin Combination

Ipca Laboratories Ltd0 个研究点目标入组 600 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
600

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. Patients receiving stable doses of sulfonylurea and at least 1000 mg dose of metformin for at least 3 months. 2. Patients with HbA1c more than 7 %
  • 3.Patients with ideal body weight of more than 60 kg
  • 4. Patients ready to undergo follow-up of 52 weeks
  • 5. Patients ready to give written, signed and dated informed consent to participate in the study

排除标准

  • 1. Patients with other than type 2 diabetes (Type 1 diabetes).2.Patients with a history of any retinopathy of any grade including diabetic retinopathy, 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.3.Patients with significant cardiovascular illness limiting participation of patient in a clinical trial.4.Patients receiving/requiring insulin.5.Patients who have used another investigational agent / device or participated in a clinical trial within the last 30 days prior to enrollment.6.Patients with substance abuse will be excluded.7.Pregnant or lactating women.8.Women of childbearing potential not practicing contraception

研究者

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