Efficacy of Maximum and Optimum Doses of Hydroxychloroquine Added to Patients with Poorly Controlled Type 2 Diabetes on Stable Insulin Therapy along with Glimepiride And Metformin: Association of High-Sensitive C-Reactive Protein (Hs-CRP) and Glycosylated Haemoglobin (Hba1c)

Aim: To determine the efficacy of maximum and optimum dosages of hydroxychloroquine (400 and 200 mg once daily) treatment combined with insulin along with metformin and Glimepiride in Type 2 diabetes patients who are poorly controlled and relationship to be evaluate between high-sensitive C-reactive protein (hs-CRP) and glycosylated haemoglobin (HbA1c) levels in such patients.Methods: In a multicentre,open-labelled comparative observational study, randomised 240 patients [mean age 56.44 years and mean body mass index (BMI) 33.20 kg/m2, mean glycosylated haemoglobin (HbA1C) 8.58% ; mean duration of diabetes 13.7 years] with type 2 diabetes who were poorly controlled with a high stable insulin dose (≥ 30 Units/day for ≥ 30 days), glimepiride (2 mg/day) and metformin (1000 mg/day) were randomly allocated to either hydroxychloroquine 200 or 400 mg once daily for 6 months (24 weeks).Results: At completion of 6 months (24 weeks), statistically significant, dose-dependent mean decreases from baseline were seen in both the hydroxychloroquine 200 and 400 mg groups for HbA1C (-0. and -1.3%, respectively) (p<0.0001), fasting plasma glucose (FPG) (-29.5 mg/dl and -33.2 mg/dl, respectively) (p<0.0001) and postprandial plasma glucose (PPG) (-39.6 mg/dl and -49.8 mg/dl, respectively) (p<0.0001) . Insulin dosage also decreased significantly in both the groups (-5.6 and -9.8 IU/day, respectively; p ≤ 0.05) from baseline. Insulin dose has reduced in significant number of patients. In the present study of type 2 diabetes patients, we found that hs-CRP levels correlated with HbA1c levels.Conclusions: In type 2 diabetes patients who are poorly controlled, addition of hydroxychloroquine (HCQ) to insulin along with Glimepiride and Metformin significantly improved glycemic control in a dose-dependent manner and was generally well tolerated. In type 2 diabetes patients who are poorly controlled by oral antidiabetic or insulin or in combination, reduction in hs-CRP highly influence HbA1c reduction.