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Initial combination therapy

First-line dual therapy with INVOKAMET® XR demonstrated superior reductions in A1C vs metformin XR alone1

In patients inadequately controlled with diet and exercise

 

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


Adjusted Mean Change in A1C From BaselineAdjusted Mean Change in A1C From Baseline
*Metformin XR titration up to 2000 mg/day was allowed through week 9 of the study. At week 26, the mean dose of metformin XR was 1924, 1909, and 1930 mg/day in the INVOKANA® 100 mg/metformin XR, INVOKANA® 300 mg/metformin XR, and metformin XR groups, respectively. The doses of INVOKANA® were not titrated.1

  • INVOKANA® 100 mg/metformin XR difference from metformin XR: –0.46% (95% CI: –0.66, –0.27; P=0.001)1
  • INVOKANA® 300 mg/metformin XR difference from metformin XR: –0.48% (95% CI: –0.67, –0.28; P=0.001)1

Adjusted mean change in A1C from baseline with INVOKANA® monotherapy1:

  • INVOKANA® 100 mg alone: –1.37% (n=230; mean baseline: 8.8%)
  • INVOKANA® 300 mg alone: –1.42% (n=234; mean baseline: 8.8%)

In this study, canagliflozin and metformin XR were coadministered as individual tablets.1,2

Adjusted mean change in A1C with INVOKAMET® XR vs metformin XR in a subgroup of patients with a baseline A1C ≥9%1

In patients inadequately controlled with diet and exercise
 

Subgroup Analysis: Adjusted Mean Change in A1C in Patients With a Baseline A1C ≥9% at 26 Weeks (%)


Reductions in A1C by baseline: INVOKAMET® XR vs metformin XR aloneReductions in A1C by baseline: INVOKAMET® XR vs metformin XR alone

Adjusted mean change in A1C from baseline with INVOKANA®1

  • INVOKANA® 100 mg alone: –1.94% (n=93; mean baseline: 9.9%) 
  • INVOKANA® 300 mg alone: –2.03% (n=96; mean baseline: 10.0%) 

Subgroup Analysis: Adjusted Mean Change in A1C in Patients With a Baseline A1C <9% at 26 Weeks (%)



  • INVOKANA® 100 mg alone: –0.97% (n=144; mean baseline: 8.1%)
  • INVOKANA® 300 mg alone: –0.99% (n=142; mean baseline: 8.0%)

SELECT IMPORTANT SAFETY INFORMATION FROM PRESCRIBING INFORMATION

  • Individualize the starting dose of INVOKAMET® XR, taken once daily with the morning meal, based on the effectiveness and tolerability of the patient's current regimen2
  • Limit the dose of INVOKAMET® XR to 2 tablets, each tablet containing canagliflozin 50 mg, in patients with moderate renal impairment with an eGFR of 45 to <60 mL/min/1.73 m2 

Study Design

A randomized, double-blind, 26-week phase 3 study of 1186 patients with type 2 diabetes not on antihyperglycemic agent (AHA) therapy or off AHA therapy for ≥12 weeks before screening. The patients’ diabetes was inadequately controlled with diet and exercise. Patients were randomized and received ≥1 dose of canagliflozin 100 mg plus metformin XR (n=237), canagliflozin 300 mg plus metformin XR (n=237), canagliflozin 100 mg alone (n=237), canagliflozin 300 mg alone (n=238), or metformin XR alone (n=237). During the double-blind treatment period, patients in all treatment groups were instructed to take 2 capsules of canagliflozin or matching placebo each day, 1 capsule taken before a morning meal and 1 capsule taken with the evening meal. Those receiving metformin XR alone or with canagliflozin were titrated up to 2000 mg/day over the first 9 weeks; the doses of canagliflozin were not titrated. The prespecified primary endpoint was the change in A1C at 26 weeks.1

 

Learn about SAFETY

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

References: 1. Rosenstock J, Chuck L, González-Ortiz M, et al. Initial combination therapy with canagliflozin plus metformin versus each component as monotherapy for drug-naïve type 2 diabetes. Diabetes Care. 2016;39(3):353-362. 2. INVOKAMET® XR [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.