Efficacy of Hydroxychloroquine as an Add on Drug with Basal Insulin, Gliclazide and Metformin in Subjects with Uncontrolled Type 2 Diabetes Mellitus

The aim of the study was to evaluate the clinical safety and efficacy of hydroxychloroquine in subjects with were poorly controlled type 2 diabetes mellitus (T2DM), despite treatment with insulin glargine and a combination of gliclazide and metformin. 105 patients with type 2 DM, mean age 56.84 years and mean body mass index (BMI) 26.30 kg/m2, were enrolled in this multicentre open label trial. They were given hydroxychloroquine 400 mg/day in addition to previous treatment with insulin glargine (≥30 units a day), gliclazide (80 mg a day) and metformin (1000 mg a day) for a period of six months. Hydroxychloroquine 400 mg/day, when added to insulin glargine and the combination of gliclazide and metformin, significantly decreased hemoglobin A1c (HbA1c) at six months from a mean of 8.15±0.24 to a mean of 6.69±0.42 (p<0.0001) and fasting plasma glucose (FPG) at six months from a mean of 209.5 ± 31.23 mg/dl to 115.14 ± 36.94 mg/dl and post prandial plasma glucose (PPG) from a mean of 338.22 ± 31.76 mg/dl to 147.71 ±22.47 mg/dl (p<0.0001). Hydroxychloroquine was well tolerated throughout the study period. The mean dose of insulin glargine decreased during the study from 35.51 ± 9.93 units per day to 20.00 ± 9.6 units/day at six months (p<0.0001). The frequency of insulin glargine injections decreased from a mean of 2.15 ± 0.22/day to 1.18 ± 0.85/day (p<0.0001). In 43 (41%) patients insulin glargine had to be totally stopped. In 13 (12%) patients the dose of gliclazide decreased to 40 mg. Hydroxychloroquine was found to improve glycemic control, when given as a fourth drug (quadruple drug therapy) in addition to insulin and the combination of gliclazide and metformin in patients with type 2 DM. In a significant number of patients, insulin therapy could be stopped, and in the rest the dose of insulin and gliclazide could be reduced