title: Diabetes-Related Composite Quality End Point Attainment: Canagliflozin Versus Sitagliptin Based on a Pooled Analysis of 2 Clinical Trials.
abstract: OBJECTIVE
  This post hoc analysis evaluated attainment of diabetes-related composite quality measures (CQMs) with canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg in patients with type 2 diabetes mellitus (T2DM). We used pooled data from two 52-week Phase III clinical trials evaluating the efficacy of canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg.
  
  
  METHODS
  CQMs assessed included the combined attainment of glycosylated hemoglobin (HbA1c), blood pressure (BP), and LDL-C. To assess on-treatment differences at 52 weeks, odds ratios (ORs) and associated 95% CIs were calculated based on a logistic regression model. CQM attainment was assessed in the overall population and for patients with a body mass index ≥25 kg/m(2) at baseline.
  
  
  RESULTS
  Overall, baseline demographic and disease characteristics were comparable across treatment groups. Proportions of patients with T2DM meeting the CQMs HbA1c <7.0%, BP <130/80 mm Hg, and LDL-C <100 mg/dL and HbA1c <8.0%, BP <140/90 mm Hg, and LDL-C <100 mg/dL were similar at baseline. After 52 weeks of treatment, the proportion of patients meeting both CQMs was similar for canagliflozin 100 mg and sitagliptin 100 mg, and favored canagliflozin 300 mg versus sitagliptin 100 mg. For canagliflozin 300 mg, the OR was 1.79 (95% CI, 1.25-2.58) for the CQM HbA1c <7.0%, BP <130/80 mm Hg, and LDL-C <100 mg/dL; the OR was 1.49 (95% CI, 1.15-1.92) for the CQM HbA1c <8.0%, BP <140/90 mm Hg, and LDL-C <100 mg/dL. CQM attainments for patients with a body mass index ≥25 kg/m(2) were similar to those for the overall population.
  
  
  CONCLUSIONS
  At 52 weeks of treatment, this analysis observed comparable CQM attainment for canagliflozin 100 mg, and superior CQM attainment for canagliflozin 300 mg, compared with sitagliptin 100 mg. ClinicalTrials.gov identifiers are NCT01106677 and NCT01137812.
authors: Janssen Scientific Affairs, LLC, Raritan, New Jersey. Electronic address: rbailey5@its.jnj.com.
authors: Robert A
authors: RA
authors: Bailey
authors: Janssen Research and Development, LLC, Raritan, New Jersey.
authors: Ujjwala
authors: U
authors: Vijapurkar
authors: Janssen Research and Development, LLC, Raritan, New Jersey.
authors: Gary
authors: G
authors: Meininger
authors: Janssen Scientific Affairs, LLC, Raritan, New Jersey.
authors: Marcia F T
authors: MF
authors: Rupnow
authors: Department of Endocrinology, Diabetes and Metabolic Diseases, Ochsner Medical Center, New Orleans, Louisiana.
authors: Lawrence
authors: L
authors: Blonde
mesh_terms: D001794:Blood Pressure / Q000187:drug effects; D015992:Body Mass Index; D000068896:Canagliflozin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D005260:Female; D005960:Glucosides / Q000009:adverse effects; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011719:Pyrazines / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic; D000068900:Sitagliptin Phosphate / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000627:therapeutic use; D014230:Triazoles / Q000627:therapeutic use
chemical_list: D000068896:Canagliflozin; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D011719:Pyrazines; D000068900:Sitagliptin Phosphate; D013876:Thiophenes; D014230:Triazoles
keywords: T2DM; canagliflozin; composite quality measures; diabetes; quality measures; sitagliptin