To evaluate the efficacy and safety of hydroxychloroquine (HCQ) as add-on therapy in adults with type 2 diabetes with inadequate glycemic control on vildagliptin plus metformin as compare to canagliflozin.
This is a 24-week, multicentre, randomised, parallel-group, and open label study. Total 87 T2DM patients were included in this analysis who were having no history of CV events and retinal abnormality, received HCQ 400 mg (n = 43) or canagliflozin 300 mg (n = 44) once daily added to background medication consisting of a stable maximum tolerated dose of vildagliptin (100 mg) and Metformin (2000 mg). The primary efficacy variable was change from baseline in HbA1c at week 24. Additional analyses included the changes in fasting plasma glucose (FPG), and postprandial glucose (PPG) and tolerability assessments included adverse events (AEs), hypoglycaemia and body weight.
The baseline patient demographics were: mean age 56±10 years; mean BMI 27.6±1.4 kg/m2; average duration of diabetes 6.1±3.1 years; 66.2% male participants. The mean HbA1c levels decreased from 8.32±0.26 to 7.11±0.18% (p=0.001) in HCQ group and 8.6±0.15 to 7.44±0.21% (p=0.001) in the canagliflozin group. The difference between groups was not significant (P=0.29). FPG and PPG levels decreased from 143±12.8 mg/dl to 112±10.7 mg/dl (p=0.001) and 210±21.7 mg/dl to 142±12.7 mg/dl (p=0.001) in HCQ group as compare to 147±13.2 mg/dl to 117±10.7 mg/dl (p=0.001) and 219±20.8 mg/dl to 153±12.7 mg/dl (p=0.001) in canagliflozin group. In the hydroxychloroquine group, BMI decreased significantly from 27.2±1.6 kg/m2 to 25.69±1.26 kg/m2. (P=0.003) whereas with canagliflozin it was almost same 27.9±1.4 kg/m2 to 27.51±1.26 kg/m2 (P=0.312). In the HCQ and canagliflozin groups, rates of reported hypoglycaemia were 5.4% and 8.2%, respectively, and rates of confirmed hypoglycaemia (symptoms + glucose < 50 mg/dl) were 0 and 2.27%.
Discussion : The study presented here is the first to directly compare efficacy and safety of hydroxychloroquine and canagliflozin in real world set up.
Addition of HCQ 400 mg/day in patients inadequately controlled on vildagliptin plus metformin effectively improved glycaemic control and was well tolerated. Efficacy and safety of HCQ was at per with canagliflozin 300 mg. In countries like India HCQ can be an alternative for patients who cannot afford canagliflozin for high cost.
Amit Gupta– Endocrinologist, G D Diabetes Institute, Kolkata, West Bengal, India, Kolkata, West Bengal, India
Rishad Ahmed– Associate Professor, Dept. of Medicine, KPC Medical College & Hospital, Kolkata, West Bengal, India, Kolkata, West Bengal, India
Surendra Prasad Singh– Assistent Professor, Patna Medical College & Hospital, Patna, Bihar, India, Bihar, India
Manish Kumar– Senior Resident, Medicine, Patna Medical College & Hospital, Patna, Bihar, India, Patna, India
Abhishek Chandra– Physician & Diabetologist, Kurji Holy Family Hospital, Patna, Bihar, India, Patna, Bihar, India
Amit Kumar– Diabetologist, Sugar Care, Patna, Bihar, India, Patna, West Bengal, India
G D Diabetes Institute, Kolkata, West Bengal, India
Kolkata, West Bengal, India
Researcher and academician. 25 Publication on international journal, 5 International abstract presented, 8+ years of experience endocrinology clinical practice. Associated with premier institute for endocrinology and Diabetes.
Dept. of Medicine, KPC Medical College & Hospital, Kolkata, West Bengal, India
Kolkata, West Bengal, India
Researcher and Diabetologist. 20 research paper published in international journel, 3 abstract presented in international conference. 8+ years of teaching expedience and research.
Patna Medical College & Hospital, Patna, Bihar, India, Bihar, India
Researcher and academician. 18 years of experience in medical teaching and research. 8 research paper published in various international journal.
Medicine, Patna Medical College & Hospital, Patna, Bihar, India
Researcher and Clinician. 4 research paper submitted at International Journal. Involved in various research projects on diabetes and endocrinology.
Physician & Diabetologist
Kurji Holy Family Hospital, Patna, Bihar, India
Patna, Bihar, India
Researcher and Clinician.