FDA approved Kazano (alogliptin and metformin HCl) for Type 2 DiabetesFDA approved Kazano, a new combination pill for type 2 diabetes.

Alogliptin is a dipeptidyl-peptidase-4 (DPP-4) inhibitor that slows the inactivation of incretin hormones, increasing their levels and thereby reducing fasting and postprandial glucose. Metformin HCl is a biguanide that decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity.

Kazano is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is not recommended for use in patients with type 1 diabetes mellitus.

Individualize the starting dosage based on the patient's current regimen. Administer orally twice daily with food. Adjust dosage based on effectiveness and tolerability, not exceeding the maximum recommended daily dose of 25 mg alogliptin and 2000 mg metformin HCl. Assess renal function prior to initiation. Do not use in patients with eGFR below 60 mL/min/1.73 m². Discontinue at the time of or prior to iodinated contrast imaging procedures in certain patients; re-evaluate eGFR 48 hours after the procedure and restart if stable.

In a 26-week, double-blind, placebo-controlled trial of 784 patients inadequately controlled on diet and exercise (mean baseline A1C = 8.4%), coadministration of alogliptin 12.5 mg with metformin HCl 500 mg or 1000 mg twice daily resulted in significant improvements in A1C and fasting plasma glucose compared to the respective individual components. Improvements in two-hour postprandial glucose were also observed. Trial data not available in label for other specific endpoints.

Contraindicated in patients with eGFR below 30 mL/min/1.73 m². Not recommended in patients with eGFR between 30 and 59 mL/min/1.73 m² because a lower daily dose of alogliptin is required. Discontinue during iodinated contrast imaging procedures in patients with eGFR between 30 and 60 mL/min/1.73 m², or with liver disease, alcoholism, or heart failure, or if intra-arterial contrast is used. Assess renal function periodically.

Kazano is a fixed-dose combination of alogliptin and metformin, offering a convenient option for patients with type 2 diabetes who are already on metformin and require additional glycemic control. It is not recommended for patients with type 1 diabetes or those with significant renal impairment. As a DPP-4 inhibitor plus metformin, it provides a complementary approach to glucose lowering, but its place relative to other combinations should be determined based on individual patient factors and clinical judgment.