The Food and Drug Administration (FDA) has approved Invokamet (canagliflozin/metformin HCl; Janssen) as a first-line treatment for adults with type 2 diabetes. Previously, this fixed-dose combination product was indicated for type 2 diabetes patients who were not adequately controlled on a regimen containing metformin or canagliflozin or who were already being treated with both of these agents.
The expanded indication was based on a 26-week, double-blind, active-controlled, multicenter Phase 3 study in 1,186 adults with type 2 diabetes inadequately controlled with diet and exercise, and who had not been treated previously with any antidiabetic drugs. The participants were assigned to one of five treatment groups: metformin HCl extended-release (MET), canagliflozin 100mg (CANA100), canagliflozin 300mg (CANA300), canagliflozin 100mg + MET (CANA100/MET), or canagliflozin 300mg + MET (CANA300/MET). The mean baseline A1C across all groups was 8.8%. The primary endpoint was the change in A1C.
After 26 weeks, patients in the CANA100/MET and CANA300/MET groups had significantly greater decreases in A1C compared to those in the CANA100, CANA300 and MET groups: 1.77% and 1.78% vs. 1.37%, 1.42% and 1.3%, respectively. In addition, significantly more patients in the CANA100/MET and CANA300/MET groups compared to the MET group achieved the goal of reducing A1C to less than 7%: 47% and 51% vs. 38%, respectively.
Studies have shown that administration of Invokamet results in the same levels and effects of canagliflozin and metformin as co-administration of corresponding doses of both drugs as individual tablets. Invokamet is available in four dosage strengths: 50mg/500mg, 50mg/1000mg, 150mg/500mg, and 150mg/1000mg tablets.
Invokamet combines Invokana (canagliflozin), a sodium glucose co-transporter 2 (SGLT2) inhibitor, with metformin, a biguanide antidiabetic. Canagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose (RTG), and thereby increases urinary glucose excretion. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
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