title: Efficacy and safety of hydroxychloroquine in the treatment of type 2 diabetes mellitus: a double blind, randomized comparison with pioglitazone.
abstract: OBJECTIVE
  To compare efficacy and safety of hydroxychloroquine with pioglitazone in type 2 diabetes mellitus (T2DM).
  
  
  METHODS
  This 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.
  
  
  RESULTS
  At 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.
  
  
  CONCLUSIONS
  With favorable effects on glycemic parameters and lipids, hydroxychloroquine may emerge as well tolerated therapeutic option for T2DM.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Medical Affairs and Clinical Research, Ipca Laboratories Limited , Mumbai , India.
authors.forename: Anil
authors.initials: A
authors.lastname: Pareek
authors.forename: Nitin
authors.initials: N
authors.lastname: Chandurkar
authors.forename: Nihal
authors.initials: N
authors.lastname: Thomas
authors.forename: Vijay
authors.initials: V
authors.lastname: Viswanathan
authors.forename: Alaka
authors.initials: A
authors.lastname: Deshpande
authors.forename: O P
authors.initials: OP
authors.lastname: Gupta
authors.forename: Asha
authors.initials: A
authors.lastname: Shah
authors.forename: Arjun
authors.initials: A
authors.lastname: Kakrani
authors.forename: Sudhir
authors.initials: S
authors.lastname: Bhandari
authors.forename: N K
authors.initials: NK
authors.lastname: Thulasidharan
authors.forename: Banshi
authors.initials: B
authors.lastname: Saboo
authors.forename: Shashidhar
authors.initials: S
authors.lastname: Devaramani
authors.forename: N B
authors.initials: NB
authors.lastname: Vijaykumar
authors.forename: Shrikant
authors.initials: S
authors.lastname: Sharma
authors.forename: Navneet
authors.initials: N
authors.lastname: Agrawal
authors.forename: M
authors.initials: M
authors.lastname: Mahesh
authors.forename: Kunal
authors.initials: K
authors.lastname: Kothari
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005907:Gliclazide / Q000627:therapeutic use; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006886:Hydroxychloroquine / Q000627:therapeutic use*; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D000077205:Pioglitazone; D013453:Sulfonylurea Compounds / Q000627:therapeutic use; D045162:Thiazolidinediones / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D005907:Gliclazide; D006442:Glycated Hemoglobin; D006886:Hydroxychloroquine; D007004:Hypoglycemic Agents; D008687:Metformin; D000077205:Pioglitazone; D013453:Sulfonylurea Compounds; D045162:Thiazolidinediones; C517652:hemoglobin A1c protein, human; C057619:glimepiride
keywords: Hydroxychloroquine; Metformin; Pioglitazone; Sulfonylurea; Type 2 diabetes mellitus