initial dual therapy may impact the course of treatment for patients with high baseline A1C1

In patients inadequately controlled on metformin XR, INVOKAMET® XR demonstrated superior reductions in A1C vs metformin XR from a baseline of ~8.8% and reductions in a subgroup of patients with a high baseline A1C1

Adjusted mean change in A1C from baseline at 26 weeks (%)1

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

Adjusted mean change in A1C from baseline with INVOKANA® (canagliflozin) monotherapy:

  • 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

Bioequivalence of INVOKAMET® XR to canagliflozin and metformin XR and of INVOKAMET® to canagliflozin and metformin coadministered as individual tablets was demonstrated in healthy subjects.2,3

Subgroup analysis: adjusted mean change in A1C in patients with a baseline A1C ≥9% at 26 weeks (%)1

A1C reductions with INVOKAMET® XR vs. metformin XR in patients with high baseline A1C

Adjusted mean change in A1C from baseline with INVOKANA® (canagliflozin) monotherapy:

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

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

Subgroup analysis: adjusted mean change in A1C in patients with a baseline A1C <9% at 26 weeks (%)1

A1C reductions >9% with INVOKAMET® XR vs. metformin XR

Adjusted mean change in A1C from baseline with INVOKANA® (canagliflozin) monotherapy:

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

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

*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

Initial dual therapy vs metformin XR at 26 weeks (Rosenstock et al)

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

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. 3. INVOKAMET® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.