Efficacy of Hydroxychloroquine as an Add on Drug with Basal Insulin, Gliclazide and Metformin in Subjects with Uncontrolled Type 2 Diabetes Mellitus
International Journal of Diabetes and Endocrinology
Volume 3, Issue 4, December 2018, Pages: 58-62
Received: Nov. 25, 2018;
Accepted: Dec. 11, 2018;
Published: Jan. 7, 2019
Views 373 Downloads 66
Abhishek Kumar Chandra, Department of Medicine, Kurji Holy Family Hospital, Patna, India
Sajjad Ahsan, Department of Endocrinology, Indira Gandhi Institute of Medical Science, Patna, India
Prakash Ranjan, The National Institute of Health and Family Welfare, New Delhi, India
Ajeet Kumar Sinha, Head of the Department, Department of Medicine, Kurji Holy Family Hospital, Patna, India
Rajeev Ranjan Kumar, Department of Medicine, All India Institute of Medical Sciences, Patna, India
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.
Abhishek Kumar Chandra,
Ajeet Kumar Sinha,
Rajeev Ranjan Kumar,
Efficacy of Hydroxychloroquine as an Add on Drug with Basal Insulin, Gliclazide and Metformin in Subjects with Uncontrolled Type 2 Diabetes Mellitus, International Journal of Diabetes and Endocrinology.
Vol. 3, No. 4,
2018, pp. 58-62.
Standards of Medical Care in Diabetes—2014. Diabetes Care 2014; 37 (Suppl. 1): S14–S80 Diagnosis and Classification of Diabetes Mellitus. Diabetes Care 2014; 37 (Suppl. 1): S81–S90 - March 01, 2014.
Seema A Kaveeshwar, Jon Cornwall. The current state of diabetes mellitus in India, Australasian Medical Journal, Vol 7, No. 1, 45–48, 2014.
P. K. Patnaik, K. K. Jain, P. Chandra, J. Pathak, K. V Raman, and A. Shah, “Diabetes in India: Measuring the dynamics of a public health catastrophe Current Estimates of Prevalence: Do We Know Enough About Diabetes,” pp. 77–84, 2016.
Henry RR, Gumbiner B, Ditzler T, Wallace P, Lyon R, Glauber HS. Intensive conventional insulin therapy for type 2 diabetes: metabolic effects during a 6-mo outpatient trial. Diabetes Care 1993; 16: 21-31.
U. K. Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352: 837-52.
Peters AL, Davidson MB. Insulin plus a sulfonylurea agent for treating type 2 diabetes. Ann Intern Med 1991; 115: 45-53.
Pugh JA, Wagner ML, Sawyer J, Ramirez G, Tuley M, Friedberg SJ. Is combination of sulfonylurea and insulin therapy useful in NIDDM patients? Diabetes Care 1992; 15: 953-9.
Relimpio R, Pumar A, Losada F, Mangas MA, Acosta D, Astorga R. Adding metformin versus insulin dose increase in insulin-treated but poorly controlled type 2 diabetes mellitus: an open-label randomized trial. Diabet Med 1998; 15: 997-1002.
Robinson AC, Burke J, Robinson S, Johnston DG, Elkeles RS. The effects of metformin on glycemic control and serum lipids in insulin treated NIDDM patients with suboptimal metabolic control. Diabetes Care 1998; 21: 701-5.
Yki-Jarvinen H, Ryysy L, Nikkila K, Tulokas T, Vanamo R, Heikkila M. Comparison of bedtime insulin regimens in patients with type 2 diabetes mellitus: a randomized, controlled trial. Ann Intern Med 1999; 130: 389-96.
Yki-Jarvinen H, Kauppila M, Kujansuu E, et al. Comparison of insulin regimens in patients with non-insulin dependent diabetes mellitus. N Engl J Med 1992; 327: 1426-33.
Chow C-C, Tsang LWW, Sorensen JP, Cockram CS. Comparison of insulin with or without continuation of oral hypoglycemic agents in the treatment of secondary failure in NIDDM patients. Diabetes Care 1995; 18: 307-14.
Riddle MC, Schneider J. Beginning insulin treatment of obese patients with evening 70/30 insulin plus glimepiride versus insulin alone: Glimepiride Combination Group. Diabetes Care 1998; 21: 1052-7.
Wolffenbuttel BH, Sels JP, Rondas-Colbers GJ, Menheere PP, Nieuwenhuijzen KA. Comparison of different insulin regimens in elderly patients with NIDDM. Diabetes Care 1996; 19: 1326-32.
Pareek A., et al. “Efficacy and safety of hydroxychloroquine in the treatment of type 2 diabetes mellitus: a double blind, randomized comparison with pioglitazone”. Current Medical Research and Opinion 30.7 (2014): 1257-1266.
Jagnani VK, Bhattacharya NR, Satpathy SC, Hasda GC, Chakraborty S. Effect of hydroxychloroquine on type 2 diabetes mellitus unresponsive to more than two oral antidiabetic agents. J Diabetes Metab. 2017; 8: 771.
Baidya A, Chakravarti HN, Saraogi RK, Gupta A, Ahmed R, et al. 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). Endocrinol Metab Syndr. 2018; 7: 283-7.
Kumar V, Singh MP, Singh AP, Pandey MS, Kumar S, Kumar S. Efficacy and safety of Hydroxychloroquine when added to stable insulin therapy in combination with metformin and glimepiride in patients with type 2 diabetes compare to sitagliptin. Int J Basic Clin Pharmacol 2018; 7.
Ranjan P, Ahsan S, Bhushan R, Kumar B, Tushar, et al. Comparison of Effi cacy and Safety of Hydroxychloroquine and Teneligliptin in Type 2 Diabetes Patients who are Inadequately Controlled with Glimepiride, Metformin and Insulin therapy: A Randomized Controlled Trial with Parallel Group Design. Ann Clin Endocrinol Metabol. 2018; 2: 030-040. https://doi.org/10.29328/journal.acem.1001009