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INVOKANA® demonstrated statistically significant reductions in A1C vs placebo in patients aged 55 to 80 years at 26 weeks1,2

In patients inadequately controlled on current antihyperglycemic agent therapy*

Adjusted Mean Change in A1C From Baseline at 26 Weeks (%)

A1C reductions in older patients inadequately controlled on current antihyperglycemic therapy: INVOKANA® vs placeboA1C reductions in older patients inadequately controlled on current antihyperglycemic therapy: INVOKANA® vs placebo

  • INVOKANA® 100 mg difference from placebo: –0.57% (95% CI: –0.71, –0.44; P <0.001)
  • INVOKANA® 300 mg difference from placebo: –0.70% (95% CI: –0.84, –0.57; P <0.001)

Secondary endpoint: In older patients, INVOKANA® also demonstrated significant reductions from baseline in body weight compared with placebo (P<0.001)1

Mean percent reduction in body weight from baseline at 26 weeks2:

  • INVOKANA® 100 mg: –2.4% (–4.9 lb)
  • INVOKANA® 300 mg: –3.1% (–6.2 lb)
  • Placebo: –0.1% (–0.2 lb)

INVOKANA® is not indicated for weight loss.

Secondary endpoint: INVOKANA® demonstrated reductions in A1C at 104 weeks3

Adjusted mean change in A1C from baseline at 104 weeks3

  • INVOKANA® 100 mg + diet and exercise +/– AHAs (n=241; mean baseline: 7.8%): –0.32%
  • INVOKANA® 300 mg + diet and exercise +/– AHAs (n=236; mean baseline: 7.7%): –0.43%
  • Placebo + diet and exercise +/– AHAs (n=237; mean baseline: 7.8%): +0.17%

SELECT IMPORTANT SAFETY INFORMATION FROM PRESCRIBING INFORMATION

Symptomatic hypotension can occur after initiating INVOKANA®, particularly in elderly patients. Before initiating INVOKANA®, assess volume status, and monitor for signs and symptoms after initiating therapy.1

INVOKANA® demonstrated a similar overall incidence of adverse events vs placebo over 104 weeks3,4

Overall Safety and Select Adverse Events and Discontinuation Rates With INVOKANA® vs Placebo Over 104 Weeks3,4

  Placebo
(n=237)
Discontinuation rate: Placebo
(n=237)
INVOKANA® 100 mg
(n=241)
Discontinuation rate: INVOKANA® 100 mg
(n=241)
INVOKANA® 300 mg
(n=236)
Discontinuation rate: INVOKANA® 300 mg
(n=236)
Any AE
86.1% 6.8% 88.0% 4.6% 89.8% 10.2%
AEs related to study drug 39.7% 3.8% 42.7% 3.3% 50.4% 6.4%
Serious AEs related to study drug 2.5% 1.3% 0.8% 0.4% 3.0% 0.4%
Urinary tract infection 10.1% 0% 14.5% 0% 16.5% 0.8%
Incidence of hypoglycemia 6.6% 0.4% 18.3% 0% 10.9% 0%
Osmotic diuresis–related AEs§ 5.5% 0% 9.1% 0% 12.3% 0.4%
Volume-related AEs|| 1.7% 0% 5.4% 0% 5.9% 0.4%
Genital mycotic infection
           
Male 1.4% 0% 5.6% 0.4% 10.9% 0.8%
Female# 4.3% 0% 23.9% 0.4% 18.7% 1.2%
  Placebo (n=237) INVOKANA® 100 mg (n=241) INVOKANA® 300 mg (n=236)
Any AE
86.1% 88.0% 89.8%
AEs related to study drug 39.7% 42.7% 50.4%
Serious AEs related to study drug 2.5% 0.8% 3.0%
Urinary tract infection 10.1% 14.5% 16.5%
Incidence of hypoglycemia 6.6% 18.3% 10.9%
Osmotic diuresis–related AEs§ 5.5% 9.1% 12.3%
Volume-related AEs|| 1.7% 5.4% 5.9%
Genital mycotic infection
Male 1.4% 5.6% 10.9%
Female# 4.3% 23.9% 18.7%
Discontinuation Rates
Any AE
6.8% 4.6% 10.2%
AEs related to study drug 3.8% 3.3% 6.4%
Serious AEs related to study drug 1.3% 0.4% 0.4%
Urinary tract infection 0% 0% 0.8%
Incidence of hypoglycemia 0.4% 0% 0%
Osmotic diuresis–related AEs§ 0% 0% 0.4%
Volume-related AEs|| 0% 0% 0.4%
Genital mycotic infection
Male 0% 0.4% 0.8%
Female# 0% 0.4% 1.2%

All adverse events are reported, regardless of rescue medication.
Possibly, probably, or very likely related to study drug, as assessed by investigators.
Patients not on an antihyperglycemic agent associated with hypoglycemia (ie, insulin, sulfonylurea, glinide); placebo, n=61; INVOKANA® 100 mg, n=60; INVOKANA® 300 mg, n=64.
§Including dry mouth, dry throat, micturition urgency, nocturia, pollakiuria, polydipsia, polyuria, thirst, and urine output increased.
||Including dehydration, dizziness postural, hypotension, orthostatic hypotension, orthostatic intolerance, presyncope, and syncope.
Placebo, n=143; INVOKANA® 100 mg, n=124; INVOKANA® 300 mg, n=129; including balanitis, balanitis Candida, balanoposthitis, balanoposthitis infective, and genital infection fungal.
#Placebo, n=94; INVOKANA® 100 mg, n=117; INVOKANA® 300 mg, n=107; including genital infection fungal, vaginal infection, vaginal inflammation, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis.

SELECT IMPORTANT SAFETY INFORMATION

Bone Fracture: Increased risk of bone fracture, occurring as early as 12 weeks after treatment initiation, was observed in patients using INVOKANA®. Consider factors that contribute to fracture risk prior to initiating INVOKANA®.

Study Design

A randomized, double-blind, placebo-controlled study to evaluate the efficacy of INVOKANA® in 714 older patients (aged 55 to 80 years) who were inadequately controlled on their current diabetes therapy (either diet and exercise alone or in combination with antihyperglycemic treatment). Patients were randomized to the addition of INVOKANA® 100 mg, INVOKANA® 300 mg, or placebo, administered once daily. The primary endpoint was the change in A1C from baseline through week 26.1,2  

See the results of INVOKANA® AS MONOTHERAPY, VS JANUVIA®, VS GLIMEPIRIDE, and in PATIENTS WITH RENAL IMPAIRMENT.

References: 1. INVOKANA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 2. Bode B, Stenlöf K, Sullivan D, Fung A, Usiskin K. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract. 2013;41(2):72-84. 3. Bode B, Stenlöf K, Harris S, et al. Long-term efficacy and safety of canagliflozin over 104 weeks in patients aged 55-80 years with type 2 diabetes. Diabetes Obes Metab. 2015;17(3):294-303. 4. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ.