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FDA Approves J&J’s Invokamet Combo (SGLT-2 + Metformin)

The US Food and Drug Administration has approved Invokamet, a fixed-dose therapy combining Invokana (canagliflozin) and metformin….

Invokana, a member of the new class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors, was approved in the USA as a single agent in March 2013.

The thumbs-up is based on Phase 3 studies which showed that the combo lowered blood sugar and reduced secondary endpoints of body weight and systolic blood pressure to a greater degree than metformin alone. Invokamet is the first fixed-dose combination of an SGLT2 inhibitor with metformin to be approved in the USA and is available at two doses (50mg/500mg or 150mg/1000 mg) to be taken twice daily.

See more SGLT-2 Resources

“Invokamet combines, in one tablet, two complementary therapeutic approaches proven effective for managing type 2 diabetes,” said Richard Aguilar, M.D., Medical Director of Diabetes Nation. “Canagliflozin works with the kidney to promote the loss of glucose in the urine, whereas metformin decreases the production of glucose in the liver and improves the body’s response to insulin.”

Invokamet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled by treatment that includes either canagliflozin or metformin, or who are already being treated with both canagliflozin and metformin as separate medications. Invokamet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Study results demonstrated that administration of Invokamet was equivalent to co-administration of corresponding doses of canagliflozin and metformin as individual tablets.

Invokamet will be available in tablets containing canagliflozin 50 milligrams (mg) or 150 mg, and metformin 500 mg or 1000 mg. The recommended dosing is twice daily. The prescribing information for Invokamet also contains a boxed warning for lactic acidosis.

The co–administration of Invokana and metformin has been studied in six Phase 3 clinical studies that enrolled 4,732 patients with type 2 diabetes. The studies evaluated Invokana in combination with metformin compared to metformin alone or to metformin plus another diabetes therapy. The studies were part of the comprehensive global Phase 3 program for Invokana that enrolled 10,285 patients, one of the largest clinical programs in type 2 diabetes submitted to health authorities to date.

In two studies comparing Invokana plus metformin to current standard treatments plus metformin – one studying sitagliptin and the other studying glimepiride – Invokana dosed at 300 mg provided greater reductions in A1C levels and body weight than either comparator. Results from the Phase 3 studies showed that the most common adverse events with Invokana are female genital mycotic (fungal) infections, urinary tract infections and increased urination. These specific adverse events were generally mild to moderate in intensity and infrequently led to discontinuation in Phase 3 studies. The most common adverse reactions due to initiation of metformin, as noted in the prescribing information for that medication, are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use. Invokana can increase the risk of hypoglycemia when combined with insulin or a medication that increases insulin levels (e.g., a sulfonylurea). Therefore, a lower dose of insulin or insulin-raising medication may be required to minimize the risk of hypoglycemia when used in combination with Invokamet.

Practice Pearls:
  • Invokamet is the first SGLT-2 + metformin combo
  • The co-administration of Invokana and metformin has been studied in six Phase 3 clinical studies that enrolled 4,732 patients with type 2 diabetes
  • Invokamet provides adults with type 2 diabetes an oral therapy that lowers blood sugar and is also associated with reductions in body weight and systolic blood.

Press Release, Johnson & Johnson