• Anil Pareek, Nitin Chandurkar, Nihal Thomas, Vijay Viswanathan, Alaka Deshpande, O P Gupta, Asha Shah, Arjun Kakrani, Sudhir Bhandari, N K Thulasidharan, Banshi Saboo, Shashidhar Devaramani, N B Vijaykumar, Shrikant Sharma, Navneet Agrawal, M Mahesh, and Kunal Kothari.
• Medical Affairs and Clinical Research, Ipca Laboratories Limited , Mumbai , India.
• Curr Med Res Opin. 2014 Jul 1; 30 (7): 125712661257-66.

ObjectiveTo compare efficacy and safety of hydroxychloroquine with pioglitazone in type 2 diabetes mellitus (T2DM).Research Design And MethodsThis double-blind study randomized 267 uncontrolled type 2 diabetes patients (HbA1c ≥7.5% and ≤11.5%), post 3 months' treatment with glimepiride/gliclazide and metformin, to additionally receive hydroxychloroquine 400 mg/day (n = 135) or pioglitazone 15 mg/day (n = 132) for 24 weeks. Efficacy was assessed by changes in HbA1c, fasting (FBG) and post-prandial (PPG) blood glucose at Week 12 and Week 24.ResultsAt Week 12 and Week 24, HbA1c, FBG and PPG significantly reduced from baseline in both groups. Mean reduction in glycemic parameters at Week 12 (HbA1c: -0.56% vs -0.72%, p = 0.394; FBG: -0.99 mmol/L vs -1.05 mmol/L, p = 0.878; PPG: -1.93 mmol/L vs -1.52 mmol/L, p = 0.423) and Week 24 (HbA1c: -0.87% vs -0.90%, p = 0.909; FBG: -0.79 mmol/L vs -1.02 mmol/L, p = 0.648; PPG: -1.77 mmol/L vs -1.36 mmol/L, p = 0.415) was not significantly different between the hydroxychloroquine and pioglitazone groups. Change in total cholesterol (TC) and LDL-C was significant in favor of hydroxychloroquine (TC: -0.37 mmol/L vs 0.03 mmol/L, p = 0.002; LDL-C: -0.23 mmol/L vs 0.09 mmol/L, p = 0.003). Triglycerides significantly reduced in both groups at Week 24. Mean HDL-C remained unchanged. Study treatments were well tolerated.ConclusionWith favorable effects on glycemic parameters and lipids, hydroxychloroquine may emerge as well tolerated therapeutic option for T2DM.LimitationsThe sample size for this study was small. However, based on the encouraging results of this proof-of-concept study, longer duration studies in larger population can be conducted to further confirm these findings. TRIAL REGISTRATION DETAILS: Clinical Trial Registry-India URL: http://ctri.nic.in, Registration Number: CTRI/2009/091/001036.

38 keywords...

hide…