INVOKANA® 100 mg has a proven safety profile in patients with DKD*
and T2D who have an eGFR as low as 301

INVOKANA® 100 mg has a proven safety profile in patients with DKD* and T2D who have an eGFR as low as 301

  • N=4401
  • Mean duration of diabetes: 15.8 years
  • Mean baseline eGFR: 56.2 mL/min/1.73 m2
  • Median baseline urinary albumin-to-creatinine ratio: 927 mg/g
  Placebo INVOKANA®
100 mg
Hazard ratio
(95% CI)
Adverse event rate per 100 patient-years over 42 months1
Any adverse event (AE) 37.93 35.14 0.87 (0.82, 0.93)
Any serious AE 16.44 14.52 0.87 (0.79, 0.97)
Serious AEs related to trial drug 0.86 1.22 1.45 (0.98, 2.14)
Amputation 1.12 1.23 1.11 (0.79, 1.56)
Fracture 1.21 1.18 0.98 (0.70, 1.37)
Renal-cell carcinoma 0.09 0.02 NA
Breast cancer§ 0.16 0.41 2.59 (0.69, 9.76)
Bladder cancer 0.16 0.17 1.10 (0.45, 2.72)
Acute pancreatitis 0.04 0.10 NA
HyperkalemiaII 3.69 2.97 0.80 (0.65, 1.00)
Acute kidney injury 2.00 1.69 0.85 (0.64, 1.13)
Diabetic ketoacidosis 0.02 0.22 10.80 (1.39, 83.65)
Male genital mycotic infection 0.09 0.84 9.30 (2.83, 30.60)
Female genital mycotic infection 0.61 1.26 2.10 (1.00, 4.45)

The incidence of hypotension was 2.8% for INVOKANA® and 1.5% for placebo.2

eGFR is measured in mL/min/1.73 m 2.
*With albuminuria >300 mg/day.
Amputation, fracture, and cancer events were determined in the on-study population, whereas the other safety events were determined in the on-treatment population. The analyses for fracture, renal-cell carcinoma, acute pancreatitis, and diabetic ketoacidosis were based on confirmed and adjudicated results.
NA denotes not applicable because hazard ratios and 95% confidence intervals were reported only for outcomes with >10 events.
§The diagnosis of breast cancer was established only in women.
IIAdverse events of hyperkalemia were spontaneously reported by the investigator. The definition of hyperkalemia includes the preferred terms "hyperkalemia" and "blood potassium increased" in the Medical Dictionary for Regulatory Activities.
All potential ketone-related events were adjudicated for diabetic ketoacidosis by an independent adjudication committee on the basis of clinical presentation and predefined biochemical measures.

DKD=diabetic kidney disease; T2D=type 2 diabetes.

References: 1. Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019;380(24):2295-2306. Supplementary appendix available at: doi:10.1056/NEJMoa1811744. 2. INVOKANA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.