OBJECTIVES: Hydroxychloroquine (HCQ) 400 mg is approved by the Drug Controller General of India (DCGI) and recommended by the Research Society for the Study of Diabetes in India (RSSDI) clinical practice recommendations 2017 as add-on therapy after metformin and sulfonylurea in Type 2 Diabetes (T2DM) patients. The aim of this observational study is to compare the efficacy and safety of hydroxychloroquine 400 mg and teneligliptin 20 mg when used as add-on therapy in Indian Type 2 DM patients who were inadequately controlled (HbA1c ?7.5%) with metformin 1000 mg and glimepiride 2 mg combination.

METHODOLOGY: This study is a prospective observational study to be conducted in 2 diabetic centres of Patna city between October 2017 and May 2018 involving 180 patients followed up for 6 months. One group (N=90) of patients received hydroxychloroquine 400 mg + metformin 1000 mg + glimepiride 2 mg, the other group (N=90) received teneligliptin 20 mg + metformin 1000 mg + glimepiride 2 mg. Efficacy was assessed by fasting blood glucose (FBG), post prandial blood glucose (PPBG) and glycated haemoglobin (HbA1c) reduction. Safety was evaluated by the number of hypoglycaemic events and changes in serum creatinine levels. Home based glucose monitoring was used to detect the hypoglycaemic events. Patients who had any type of retinopathy/maculopathy were excluded.

RESULTS: Mean age of entire population was 66 ± 8 years with mean 6 ± 2 years of DM with 102 males. Mean body weight was 71 ± 12 kg. Baseline HbA1c was 8.1 ± 0.3 in the hydroxychloroquine group and 8.2 ± 0.2 in the teneligliptin group.

At 24 weeks there were statistically significant reductions in mean HbA1c in the hydroxychloroquine group (1.1 ± 0.3) as compared to the teneligliptin group (0.82 ± 0.3) (P?0.001). The mean FBG and PPBG was 169 ± 18 mg/dl and 232 ± 18 mg/dl respectively in hydroxychloroquine group which was reduced to 121 ± 15 mg/dl and 161 ± 19 mg/dl at the end of 24 weeks. In the teneligliptin group, FBG and PPBG was 171 ± 16 mg/dl and 239 ± 21 mg/dl at baseline, which was reduced to 121 ± 15 mg/dl and 161 ± 19 mg/dl respectively in same period of time (P? 0.005). There were 4 incidences of hypoglycaemic events in the hydroxychloroquine group (4.4%) and 6 in the teneligliptin group (6.67%). No patients required medical assistance for hypoglycaemic events. There was no statistically significant change in body weight in both the groups. No marked changes in creatinine levels were found in patients in both the groups.

CONCLUSION: In conclusion, treatment with hydroxychloroquine 400 mg for 24 weeks reduces glycaemic parameters more aggressively than teneligliptin 20 mg in Indian type 2 diabetes patients.