INVOKAMET® XR demonstrated a similar overall tolerability profile and incidence of hypoglycemia to metformin XR alone1

Overall safety and select adverse events with INVOKAMET® XR vs metformin XR over 26 weeks1,2

 

Metformin XR* (n=237)

INVOKANA® 100 mg/metformin XR* (n=237)

INVOKANA® 300 mg/metformin XR* (n=237)

 

 

 

 

Any AE

37.6%

41.8%

44.3%

AEs leading to discontinuation

1.7%

1.7%

3.0%

AEs related to study drug

7.2%

6.3%

14.8%

Serious AEs related to study drug

0%

0%

0%

Urinary tract infection

1.3%

1.3%

3.0%

Hypoglycemia

4.6%

4.2%

5.5%

Male genital mycotic infection

0%

0.9%

1.7%

Female genital mycotic infection§

0%

2.3%

3.3%

Osmotic diuresis–related AEs||

0.8%

0.8%

2.5%

Volume depletion–related AEs

0.4%

1.7%

0.8%

Renal-related AEs#

0%

0.4%

1.3%

Diarrhea

1.3%

4.2%

4.2%

*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

Possibly, probably, or very likely related to study drug, as assessed by investigators.

Metformin XR, n=116; INVOKANA® 100 mg + metformin XR, n=108; INVOKANA® 300 mg + metformin XR, n=115; includes balanoposthitis, genital candidiasis, and genital fungal infection.

§Metformin XR, n=121; INVOKANA® 100 mg + metformin XR, n=129; INVOKANA® 300 mg + metformin XR, n=122; includes genital infection female, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis.

||Includes dry mouth, pollakiuria, polyuria, and thirst.

Includes dehydration, dizziness postural, hypotension, orthostatic hypotension, and syncope.

#Includes blood creatinine increased, glomerular filtration rate decreased, and renal impairment.

 

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.3,4

Overall safety and select adverse events with INVOKANA® vs metformin XR over 26 weeks1,2

 

Metformin XR* (n=237)

INVOKANA® 100 mg (n=237)

INVOKANA® 300 mg (n=238)

 

 

 

 

Any AE

37.6%

37.1%

39.9%

AEs leading to discontinuation

1.7%

1.3%

2.9%

AEs related to study drug

7.2%

10.1%

9.2%

Serious AEs related to study drug

0%

0%

0.8%

Urinary tract infection

1.3%

1.3%

2.1%

Hypoglycemia

4.6%

3.0%

3.8%

Male genital mycotic infection

0%

1.9%

4.0%

Female genital mycotic infection§

0%

2.3%

4.4%

Osmotic diuresis–related AEs||

0.8%

2.1%

1.7%

Volume depletion–related AEs

0.4%

0.4%

1.3%

Renal-related AEs#

0%

3.0%

1.3%

Diarrhea

1.3%

1.3%

1.7%

*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

Possibly, probably, or very likely related to study drug, as assessed by investigators.

Metformin XR, n=116; INVOKANA® 100 mg, n=105; INVOKANA® 300 mg, n=125; includes balanoposthitis, genital candidiasis, and genital fungal infection.

§Metformin XR, n=121; INVOKANA® 100 mg, n=132; INVOKANA® 300 mg, n=113; includes genital infection female, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis.

||Includes dry mouth, pollakiuria, polyuria, and thirst.

Includes dehydration, dizziness postural, hypotension, orthostatic hypotension, and syncope.

#Includes blood creatinine increased, glomerular filtration rate decreased, and renal impairment.

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. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ. 3. INVOKAMET® XR [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 4. INVOKAMET® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.