title: A post-hoc analysis of the comparative efficacy of canagliflozin and glimepiride in the attainment of type 2 diabetes-related quality measures.
abstract: The randomized, double-blind CANTATA-SU (CANagliflozin Treatment And Trial Analysis Sulfonyl Urea) clinical trial compared the use of canagliflozin (100 mg or 300 mg) and maximally tolerated glimepiride (6-8 mg) over 104 weeks as add-on therapy for patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. Compared with glimepiride, canagliflozin use was associated with durable reductions in glycated hemoglobin (A1C), blood pressure (BP), and body weight. The aim of this post-hoc analysis of the CANTATA-SU trial was to assess the comparative efficacy of canagliflozin and glimepiride in the attainment of recently updated diabetes-related quality measures (QMs) for up to 104 weeks of treatment.
  
  
  
  This post-hoc analysis evaluated the proportions of patients achieving individual diabetes-related QMs using data from the randomized, double-blind, Phase 3 CANTATA-SU trial. Change in A1C from baseline, and proportions of the study population achieving QMs: A1C <7.0 %, <8.0 %, and >9.0 % were assessed. Secondary endpoints included change in BP from baseline, and the proportions of the study population achieving QMs related to BP and body weight.
  
  
  
  The proportions of patients in the canagliflozin 100 mg, canagliflozin 300 mg, and glimepiride groups meeting criteria for all QMs were similar at baseline. At 52 and 104 weeks of treatment, canagliflozin 100 mg and canagliflozin 300 mg provided better or similar reductions in A1C from baseline and achievement of glycemic control QMs compared with glimepiride. At 52 and 104 weeks of treatment, the attainment of QMs related to reductions in body weight and BP all favored canagliflozin compared with glimepiride. Canagliflozin was associated with lower incidence of documented hypoglycemia and severe hypoglycemia compared with glimepiride.
  
  
  
  Using the recently adjusted and currently accepted diabetes-related QMs, this analysis observed superior glycemic control with canagliflozin compared with maximally tolerated glimepiride in patients with T2DM who were previously poorly controlled on metformin monotherapy. Compared with maximally tolerated glimepiride, canagliflozin resulted in better achievement of diabetes-related QMs related to weight loss and BP, and was associated with lower incidences of hypoglycemic events.
  
  
  
  Clinical trial registry name: CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride.
  
  
  
  NCT00968812 , registered August 28, 2009.
authors: Janssen Scientific Affairs, LLC, 1000 Route 202 South, Raritan, NJ, 08869, USA. cpatel34@its.jnj.com.
authors: Charmi A
authors: CA
authors: Patel
authors: Janssen Scientific Affairs, LLC, 1000 Route 202 South, Raritan, NJ, 08869, USA.
authors: Robert A
authors: RA
authors: Bailey
authors: Janssen Research and Development, LLC, 920 US Route 202 South, Raritan, NJ, 08869, USA.
authors: Ujjwala
authors: U
authors: Vijapurkar
authors: Janssen Research and Development, LLC, 920 US Route 202 South, Raritan, NJ, 08869, USA.
authors: Gary
authors: G
authors: Meininger
authors: Ochsner Diabetes Clinical Research Unit, Frank Riddick Diabetes Institute, Department of Endocrinology, Ochsner Medical Center, 1515 Jefferson Highway, New Orleans, LA, 70121, USA.
authors: Lawrence
authors: L
authors: Blonde
mesh_terms: D000368:Aged; D001786:Blood Glucose; D001795:Blood Pressure Determination; D000068896:Canagliflozin / Q000008:administration & dosage*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005960:Glucosides / Q000627:therapeutic use; D006442:Glycated Hemoglobin; D006801:Humans; D007003:Hypoglycemia; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D019984:Quality Indicators, Health Care; D016032:Randomized Controlled Trials as Topic; D013453:Sulfonylurea Compounds / Q000008:administration & dosage*; D013876:Thiophenes / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D000068896:Canagliflozin; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D013453:Sulfonylurea Compounds; D013876:Thiophenes; C057619:glimepiride
keywords: A1C; Blood pressure; Body weight; Canagliflozin; Glimepiride; Glycemic control; Phase 3; Post-hoc analysis; Quality measures