To evaluate the Safety and Efficacy of Hydroxychloroquine as add-on therapy in uncontrolled type 2 diabetes patients who were using two oral antidiabetic drugs.
Thiswasadoubleblind,placebocontrolled,parallelgroupstudyin304inadequatelycontrolledtype 2 diabetes(T2DM)subjects with two oral antidiabetic drugs(glimepiride 4 mg and metformin 500 mg)were randomised to hydroxychloroquine(HCQ)200 mg,300 mg,400 mg once daily(OD)or placebo.Dose of hydroxychloroquine was selected as per body weight of the subject. Primary end point was glycated haemoglobin(HbA1c)change at week 12 from baseline.Secondary endpoint was change in fasting plasma glucose(FPG),post prandial plasma glucose(PPG),body weight and any adverse reaction including no of hypoglycemic events,as well as a change in the percentage of subjects with A1C < 7.0% and > 6.5% after 12 weeks of treatment.In follow-up of 400 mg once daily was once again divided to 200 mg twice daily(BD)to study the effect on tolerability profile for further 12 weeks.
Hydroxychloroquine was associated with significant reduction in HbA1c from baseline(7–8.5%)in 12 weeks −0.78%,−0.91% and 1.2% for hydroxychloroquine 200 mg,300 mg and 400 mg OD,respectively, versus 0.13% with placebo(P < 0.005).FPG and PPG were reduced by −25 to −38 mg/dl and 34–53 mg/dl,respectively.Body weight also reduced in each group of HCQ.Hypoglycemia was reported only with 300 mg(1.2%)and 400 mg(2.1%)group of HCQ.It was observed that patients who complains with mild GI disturbance with HCQ 400 mg glycemic efficacy was maintained with 200 mg BD with significant relief of the symptoms. Hydroxychloroquine added to sulphonylurea and metformin,improves glycemic control significantly in T2DM patients.Glycemic effect of different dose of hydroxychloroquine is dose dependent.The safety/tolerability profile of hydroxy-chloroquine was favourable except GI disturbance which is more frequent with 400 mg.This can be avoided with 200 mg BD without compromise on efficacy.
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