FDA approved Segluromet (ertugliflozin/metformin) for Type 2 DiabetesFDA approved new combination pill for type 2 diabetes

Ertugliflozin is a sodium glucose co-transporter 2 (SGLT2) inhibitor that reduces renal glucose reabsorption, leading to increased urinary glucose excretion. Metformin is a biguanide that improves glycemic control by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity.

Segluromet 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 to improve glycemic control in patients with type 1 diabetes mellitus.

Assess renal function prior to initiation and as clinically indicated. Correct volume depletion before initiation. Individualize the starting dosage based on the patient's current regimen. The maximum recommended dosage is 7.5 mg ertugliflozin/1,000 mg metformin orally twice daily. Take orally twice daily with meals, with gradual dose escalation. Do not use in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m2. Use is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2. Use is contraindicated in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2), end stage-renal disease (ESRD), or on dialysis. Segluromet may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures. Withhold Segluromet for at least 4 days, if possible, prior to surgery or procedures associated with prolonged fasting.

The efficacy and safety of ertugliflozin in combination with metformin HCl have been studied in 4 multicenter, randomized, double-blind, placebo- and active comparator-controlled, clinical studies involving 3,643 patients with type 2 diabetes mellitus. In patients with type 2 diabetes mellitus, treatment with ertugliflozin in combination with metformin HCl reduced hemoglobin A1c (HbA1c) compared to placebo. In a 26-week placebo-controlled study (NCT02033889) of 621 patients inadequately controlled on metformin monotherapy, ertugliflozin added to metformin reduced HbA1c compared to placebo. The reduction in HbA1c was generally similar across subgroups defined by age, sex, race, geographic region, baseline body mass index, and duration of type 2 diabetes mellitus.

Contraindicated in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2), ESRD, or on dialysis. Not recommended for use in patients with type 1 diabetes mellitus. Assess renal function before initiating and as clinically indicated. Correct volume depletion before initiation. Discontinue at the time of, or prior to, iodinated contrast imaging procedures in patients with eGFR less than 60 mL/min/1.73 m2, or in patients with a history of liver disease, alcoholism, or heart failure, or in patients who will receive intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after imaging and restart if renal function is stable. Withhold for at least 4 days prior to surgery or procedures associated with prolonged fasting.

Segluromet is a fixed-dose combination of an SGLT2 inhibitor and metformin, offering a convenient option for patients who are already on both components or who may benefit from combination therapy. It is not recommended for type 1 diabetes. Consider its use in adults with type 2 diabetes who need additional glycemic control, but monitor renal function and volume status closely.