FDA Approves Steglatro (ertugliflozin) for Type 2 Diabetes Mellitus

Steglatro (ertugliflozin) is a sodium glucose co-transporter 2 (SGLT2) inhibitor. It works by blocking glucose reabsorption in the kidney, leading to increased urinary glucose excretion and lowering blood glucose levels.

Steglatro 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 before initiating and as clinically indicated. Correct volume depletion before starting. The recommended starting dosage is 5 mg orally once daily, taken in the morning, with or without food. Increase dosage to 15 mg orally once daily in those tolerating Steglatro and needing additional glycemic control. Use is not recommended in patients with eGFR less than 45 mL/min/1.73 m2. Withhold Steglatro for at least 4 days, if possible, prior to surgery or procedures associated with prolonged fasting.

In a 26-week placebo-controlled monotherapy trial (NCT01958671) in patients with type 2 diabetes inadequately controlled on diet and exercise, Steglatro 5 mg and 15 mg once daily provided statistically significant reductions in HbA1c compared to placebo. At Week 26, the mean change from baseline in HbA1c was -0.7% for 5 mg and -0.8% for 15 mg versus -0.2% for placebo. The difference from placebo was -0.6% (95% CI: -0.8, -0.4) for 5 mg and -0.7% (95% CI: -0.9, -0.4) for 15 mg. A greater proportion of patients achieved HbA1c <7% with Steglatro (30.1% for 5 mg, 38.8% for 15 mg) versus placebo (16.9%). Fasting plasma glucose reductions were also greater with Steglatro. Mean body weight decreased by 3.0 kg and 3.1 kg with Steglatro 5 mg and 15 mg, respectively, versus 1.0 kg with placebo.

Not recommended for use in patients with type 1 diabetes mellitus. Assess renal function before initiating and as clinically indicated. Correct volume depletion before starting. Use is not recommended in patients with eGFR less than 45 mL/min/1.73 m2. Withhold Steglatro for at least 4 days prior to surgery or procedures associated with prolonged fasting.

Steglatro is an SGLT2 inhibitor approved as an adjunct to diet and exercise for glycemic control in adults with type 2 diabetes. It provides an additional option for patients who need further glycemic control, with dosing flexibility (5 mg or 15 mg). Its use is limited by renal function (eGFR <45 mL/min/1.73 m2) and it is not indicated for type 1 diabetes.