Efficacy and safety of Hydroxychloroquine in the Treatment of Type II Diabetes Mellitus: A Double Blind, Randomized Comparison with Pioglitazone

Ipca Laboratories Limited0 个研究点目标入组 267 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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•1. Patients diagnosed of type II diabetes defined by ADA criteria and are uncontrolled by combination therapy of two oral hypoglycemic agents i.e. either metformin greater than or equal to 1000mg/day in combination with glimepiride greater than or equal to 4mg/day or gliclazide greater than or equal to 160mg/day combination
•3. Patients with HbA1c greater than or equal to 7.5 % and less than or equal to 11.5 % at baseline visit (HbA1C 7.5 % and less than or equal to 11.5 % for screening visit)
•4. Patients with body weight greater than or equal to 60 kg
•5. Patients willing and likely to fully comply with study procedures and restrictions and ready to give written informed consent

•1. Patients with other than Type II diabetes
•2. Patients with a history of any retinopathy including diabetic retinopathy
•3. Patients with abnormal renal and liver function.
•4. Patients with disease of blood or haematopoetic organs
•5. Patient with known history of diabetic ketoacidosis
•6. Patients receiving insulin therapy
•7. Patients with known history of hypersensitivity to hydroxychloroquine, glimepiride, gliclazide, metformin , pioglitazone or other similar drugs of same chemical class or any other ingredient of the study formulations or with history of severe allergic disease
•8. Pregnant or lactating women.
•9. Women of childbearing potential not practicing contraception.

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