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 Ltd62 个研究点分布在 1 个国家目标入组 600 人开始时间: 2016年2月15日最近更新: 2019年11月22日

适应症

试验速览

阶段: 4 期
状态: 招募中
发起方: Ipca Laboratories Ltd
入组人数: 600
试验地点: 62
主要终点: Adverse events (clinical and laboratory) and incidence of hypoglycemia

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary purpose of conducting this study is to assess the safety of hydroxychloroquine as an add on therapy to sulfonylurea and metforminwith respect to reported adverse events (clinical and laboratory) and incidence of hypoglycemia in patients with type-2 diabetes. In this study efficacy in terms of change in HbA1c, FBG and PPG and lipid profile will also be assessed.

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

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

排除标准

•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.

结局指标

主要结局

Adverse events (clinical and laboratory) and incidence of hypoglycemia

时间窗: Through-out the duration of the study including week 4, week 8, week 12,week 24, week 36 and week 52

次要结局

Change in HbA1c, FBG,PPG(at week 24 and 52)
Change in lipid profile(at week 24 and 52)

研究者

发起方

Ipca Laboratories Ltd

申办方类型

Pharmaceutical industry-Indian

研究点 (62)

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