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- Title
Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes mellitus and chronic kidney disease.
- Authors
Yale, J.‐F.; Bakris, G.; Cariou, B.; Nieto, J.; David‐Neto, E.; Yue, D.; Wajs, E.; Figueroa, K.; Jiang, J.; Law, G.; Usiskin, K.; Meininger, G.
- Abstract
Aim This study evaluated the efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus (T2DM) and within a subset of Stage 3 chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR] ≥30 and <50 ml/min/1.73 m2). Methods In this 52-week, randomized, double-blind, placebo-controlled study, patients (N = 269; mean eGFR, 39.4 ml/min/1.73 m2) received canagliflozin 100 or 300 mg and placebo once daily. Efficacy endpoints included changes in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), body weight and systolic blood pressure (BP); adverse events (AEs) were also recorded. Results At week 52, canagliflozin 100 and 300 mg reduced HbA1c compared with placebo (−0.19, −0.33 and 0.07%, respectively); placebo-subtracted differences (95% confidence interval) were −0.27% (−0.53, 0.001) and −0.41% (−0.68, −0.14). Canagliflozin also lowered FPG, body weight and BP versus placebo. Overall AE incidence was 85.6, 80.9, and 86.7% with canagliflozin 100 and 300 mg and placebo, respectively. Osmotic diuresis-related AEs were more common with both canagliflozin doses, and incidences of urinary tract infections and volume depletion-related AEs were higher with canagliflozin 300 mg versus placebo. Decreases in eGFR (−2.1, −4.0 and −1.6 ml/min/1.73 m2) were seen with canagliflozin 100 and 300 mg compared with placebo. Canagliflozin 100 and 300 mg provided median percent reductions in urine albumin to creatinine ratio versus placebo (−16.4, −28.0 and 19.7%). Conclusions Canagliflozin improved glycaemic control and was generally well tolerated in patients with T2DM and within a subset of Stage 3 CKD over 52 weeks.
- Subjects
DRUG efficacy; DIABETIC nephropathies; KIDNEY disease treatments; DIABETES; GROUP-randomized trials; GLYCEMIC index; PEOPLE with diabetes; THERAPEUTICS; DISEASES
- Publication
Diabetes, Obesity & Metabolism, 2014, Vol 16, Issue 10, p1016
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.12348