Diabetes-Related Composite Quality End Point Attainment: Canagliflozin Versus Sitagliptin Based on a Pooled Analysis of 2 Clinical Trials

Clin Ther. 2015 May 1;37(5):1045-54. doi: 10.1016/j.clinthera.2015.02.020. Epub 2015 Mar 18.

Abstract

Purpose: 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.

Findings: 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.

Implications: 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.

Keywords: T2DM; canagliflozin; composite quality measures; diabetes; quality measures; sitagliptin.

Publication types

  • Comparative Study
  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Blood Pressure / drug effects
  • Body Mass Index
  • Canagliflozin / administration & dosage
  • Canagliflozin / adverse effects
  • Canagliflozin / therapeutic use*
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / physiopathology
  • Dose-Response Relationship, Drug
  • Female
  • Glucosides / adverse effects
  • Glycated Hemoglobin A / metabolism
  • Humans
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use*
  • Male
  • Middle Aged
  • Pyrazines / adverse effects
  • Randomized Controlled Trials as Topic
  • Sitagliptin Phosphate / adverse effects
  • Sitagliptin Phosphate / therapeutic use*
  • Thiophenes / therapeutic use
  • Triazoles / therapeutic use

Substances

  • Glucosides
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Pyrazines
  • Thiophenes
  • Triazoles
  • Canagliflozin
  • Sitagliptin Phosphate

Associated data

  • ClinicalTrials.gov/NCT01106677
  • ClinicalTrials.gov/NCT01137812