FDA approved Jentadueto XR (linagliptin/metformin) for Type 2 DiabetesFDA approved Jentadueto XR for adults with type 2 diabetes.

Jentadueto XR combines two antihyperglycemic agents with complementary mechanisms of action: linagliptin, a DPP-4 inhibitor, and metformin, a biguanide. Linagliptin increases the concentrations of incretin hormones, which stimulate insulin release and decrease glucagon levels in a glucose-dependent manner. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Jentadueto XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of use: not recommended in patients with type 1 diabetes mellitus; has not been studied in patients with a history of pancreatitis.

Individualize the starting dosage based on the patient's current regimen. The maximum recommended dosage is 5 mg linagliptin/2,000 mg metformin HCl once daily. Take orally once daily with a meal, with gradual dose escalation to reduce gastrointestinal effects. Swallow whole; do not split, crush, dissolve, or chew. Prior to initiation, assess renal function with eGFR. Do not use in patients with eGFR below 30 mL/min/1.73 m². Initiation is not recommended in patients with eGFR between 30-45 mL/min/1.73 m². Assess risk/benefit of continuing if eGFR falls below 45 mL/min/1.73 m². Discontinue if eGFR falls below 30 mL/min/1.73 m². May need to be discontinued at time of, or prior to, iodinated contrast imaging procedures.

The label includes data from a 24-week, randomized, double-blind, placebo-controlled factorial trial in 791 patients with type 2 diabetes and inadequate glycemic control on diet and exercise. Patients were randomized to placebo, linagliptin 5 mg once daily, metformin 500 mg or 1,000 mg twice daily, or linagliptin 2.5 mg twice daily in combination with metformin 500 mg or 1,000 mg twice daily. The trial assessed efficacy of linagliptin as initial therapy with metformin. Specific A1C results are not detailed in the provided label text.

Jentadueto XR is contraindicated in patients with eGFR below 30 mL/min/1.73 m². It is not recommended in patients with type 1 diabetes mellitus. It has not been studied in patients with a history of pancreatitis. Discontinue at the time of or prior to iodinated contrast imaging procedures in certain patients (e.g., those with eGFR between 30 and 60 mL/min/1.73 m², liver disease, alcoholism, heart failure, or intra-arterial contrast). Re-evaluate eGFR 48 hours after imaging and restart if renal function is stable.

Jentadueto XR is a fixed-dose combination of linagliptin and metformin extended-release for use in adults with type 2 diabetes as an adjunct to diet and exercise. It is appropriate for patients who require combination therapy with a DPP-4 inhibitor and metformin. The once-daily dosing may improve adherence. It is not recommended for type 1 diabetes or for patients with a history of pancreatitis. Renal function should be monitored, and the drug should be avoided in patients with significant renal impairment.