Efficacy and safety of canagliflozin by baseline HbA1c and known duration of type 2 diabetes mellitus

J Diabetes Complications. 2015 Apr;29(3):438-44. doi: 10.1016/j.jdiacomp.2014.12.016. Epub 2014 Dec 31.

Abstract

Aims: Canagliflozin, a sodium glucose co-transporter 2 inhibitor, has demonstrated glycemic improvements across studies of patients with type 2 diabetes mellitus (T2DM). The impact of canagliflozin on HbA1c lowering was assessed by baseline HbA1c and known duration of T2DM.

Methods: This post hoc analysis pooled data from patients with T2DM enrolled in four 26-week, placebo-controlled, Phase 3 studies of canagliflozin (N=2313). Change in HbA1c from baseline to Week 26 was assessed in the overall population and in subgroups by baseline HbA1c (<8.0%, 8.0%-<9.0%, and ≥9.0%) and known duration of T2DM (<5 years, 5-<10 years, and ≥10 years).

Results: Relative to placebo, canagliflozin 100 and 300 mg provided greater HbA1c reductions in the overall population. Progressively larger placebo-subtracted reductions in HbA1c with canagliflozin 100 and 300 mg were seen with increasing baseline HbA1c. HbA1c reductions were similar across subgroups based on known duration of T2DM. Both canagliflozin doses were generally well tolerated across subgroups, with a safety and tolerability profile consistent with that seen in Phase 3 studies.

Conclusions: Canagliflozin provided glycemic improvements in patients with T2DM across a range of baseline HbA1c and known duration of T2DM.

Keywords: Canagliflozin; Efficacy; Glycemic control; Safety; Sodium glucose co-transporter 2 inhibitor; Type 2 diabetes mellitus.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Canagliflozin / adverse effects
  • Canagliflozin / therapeutic use*
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / epidemiology
  • Double-Blind Method
  • Female
  • Glycated Hemoglobin A / metabolism*
  • Humans
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use*
  • Male
  • Middle Aged
  • Placebos
  • Time Factors
  • Treatment Outcome
  • Young Adult

Substances

  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Placebos
  • hemoglobin A1c protein, human
  • Canagliflozin