FDA Says SGLT2-Metformin Combo Can Be Used Right Away

The combination diabetes therapy Invokamet, a fixed-dose of canagliflozin (Invokana) and metformin, now has FDA approval as a first-line therapy, according to statement from the drug’s manufacturer, Janssen Pharmaceuticals.

“With this new approval, Invokamet may now be prescribed in adults with type 2 diabetes (T2D) who are not already being treated with canagliflozin or metformin and may benefit from dual therapy,” the statement said.

The drug, first approved in August 2014, is the first combination of an SGLT2 inhibitor and metformin available in the United States. Canagliflozin was the first of the class of sodium-glucose co-transporter-2 (SGLT2) inhibitors approved by FDA in 2013.

Until now, Invokamet could be prescribed only for patients who were not achieving blood glucose targets on either canagliflozin or metformin, or for T2D adults who were already being treated on the drugs separately. Using combination therapy from the start allows patients to get the benefits of both medications while taking 1 pill, which may improve adherence.

Metformin has long been the standard first-line therapy for T2D; however, new treatment guidelines from the American Diabetes Association call for using combination therapy from the start for patients with more elevated levels of glycated hemoglobin (A1C).¹

A phase 3 study published in Diabetes Care in March found that among patients not taking any therapy to reduce A1C, those given the combination therapy at the outset had greater A1C reductions than those given either dose of canagliflozin (100 mg or 300 mg) or metformin separately.²

After 26 weeks, researchers reported the following A1C reductions:

· Combination therapy with 100 mg of canagliflozin: A1C reduced 1.77%

· Combination therapy with 300 mg of canagliflozin: A1C reduced 1.78%

· Monotherapy of 100 mg canagliflozin: A1C reduced 1.37%

· Monotherapy of 300 mg canagliflozin: A1C reduced 1.42%

· Monotherapy of metformin: A1C reduced 1.3%

Also, after 26 weeks, a higher share of patients given the combination therapy than those in the monotherapy groups achieved an A1C of less than 7%: 47% for the combination with 100 mg canagliflozin, 51% for those taking the combo with 300 mg canagliflozin vs 38% for the metformin group.

“Physicians increasingly try to achieve greater blood sugar control by using dual therapy at the outset, versus single-agent therapy alone, especially for patients with higher A1C levels,” said John Anderson, MD, of the Frist Clinic in Nashville, Tennessee, in the Janssen statement. Invokamet, he said, “combines 2 effective, complementary medicines—canagliflozin and metformin—into 1 convenient pill, to lower A1C significantly more than metformin alone.”

RELATED COVERAGE: Real-world data on canagliflozin in a managed care setting

References

1. American Diabetes Association. Glycemic targets, Section 5. Standard of Medical Care in Diabetes—2016. Diabetes Care. 2016;39(suppl1): S39-S46.

2. Rosenstock J, Chuck L, Gonzales-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.