Hydroxychloroquine as Add On Therapy Patients of Type 2 Diabetes Mellitus Uncontrolled on Sulfonylurea and Metformin Combination Comparison with Gliptinsâ?? real world Efficacy assessment in India (HOPE INDIA study) - HOPE-INDIA

Patna Medical College0 个研究点目标入组 2,000 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Patients receiving stable doses of sulfonylurea and at least 1000 mg metformin for at least 3 months with HbA1c >=7%
•Patients with ideal body weight > 60 kg Compliance
•Patient able to understand and willing to fully comply with study procedures and restrictions.
•Patients ready to undergo a follow-up period of 24 weeks.

•Patients with other than type 2 diabetes (Type 1 diabetes).
•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.
•Patients with history of myalgia, aplastic anemia or agranulocytosis, granulocytopenia, psoriasis, porphyria, rash, scaling, scaling eczema, and G6PD deficiency.
•Patients with significant cardiovascular illness limiting participation of patient in a clinical trial
•Patients with abnormal renal function (Serum Cr >1.5 mg/dL, BUN > 20 mg/dL).
•Patients with abnormal liver function (AST and ALT, total bilirubin or alkaline phosphatase > 2.5 times the upper limit of normal values).
•Pregnant or lactating women
•Women of childbearing potential not practicing contraception

发起方

Patna Medical College