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STEGLATRO®
(ertugliflozin) 5 mg, 15 mg tablets
Clinical Profile for STEGLATRO® (ertugliflozin)
Learn about the results of the placebo-controlled, randomized study VERTIS MONO:
(STEGLATRO IS NOT INDICATED FOR WEIGHT LOSS.)
As an adjunct to diet and exercise for appropriate adults with type 2 diabetes:
(a) N includes all randomized and treated patients with a baseline measurement of the outcome variable. At week 26, the primary A1C end point was missing for 23%, 11%, and 16% of patients, and during the trial, rescue medication was initiated by 25%, 2%, and 3% of patients randomized to placebo, STEGLATRO 5 mg, and STEGLATRO 15 mg, respectively. Missing week 26 measurements were imputed using multiple imputation with a mean equal to the baseline value of the patient. Results include measurements collected after initiation of rescue medication. For those patients who did not receive rescue medication and had values measured at 26 weeks, the mean changes from baseline for A1C were -0 .1 %, -0 .8 %, and -1 .0 % for placebo, STEGLATRO 5 mg, and STEGLATRO 15 mg, respectively.
(b) Intent-to-treat analysis using ANCOVA adjusted for baseline value, prior antihyperglycemic medication, and baseline eGFR.
As an adjunct to diet and exercise for appropriate adults with type 2 diabetes:
(c) Data to the left of the vertical line are observed means (non–model-based), excluding values occurring post glycemic rescue. Data to the right of the vertical line represent the final week 26 data, including all values regardless of use of glycemic rescue medication and use of study drug, with missing week 26 values imputed using multiple imputation (26-MI) with a mean equal to the baseline value of the patient.
(d) The primary efficacy end point was change from baseline in A1C at week 26.
As an adjunct to diet and exercise for appropriate adults with type 2 diabetes:
(e) Intent-to-treat analysis using ANCOVA adjusted for baseline value, prior antihyperglycemic medication, and baseline eGFR.
As an adjunct to diet and exercise for appropriate adults with type 2 diabetes:
A total of 461 adults with type 2 diabetes inadequately controlled (A1C between 7% and 10.5%) on diet and exercise participated in a randomized, double-blind, multicenter, 26-week, placebo-controlled study to evaluate the efficacy and safety of STEGLATRO monotherapy. These patients, who were either treatment naïve or not receiving any background antihyperglycemic treatment ≥8 weeks, entered a 2-week, single-blind, placebo run-in period and were randomized to placebo, STEGLATRO 5 mg, or STEGLATRO 15 mg, administered once daily. The primary efficacy end point was the change from baseline in A1C at week 26.1
1. Terra SG, Focht K, Davies M, et al. Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone. Diabetes Obes Metab. 2017;19(5):721–728.
2. Data available on request from Merck Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package US-STE-01493.
STEGLATRO® (ertugliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. STEGLATRO is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.
Contraindications: STEGLATRO is contraindicated in patients with hypersensitivity to ertugliflozin or any excipient in STEGLATRO, reactions such as angioedema have occurred, and in patients on dialysis.
Ketoacidosis: Ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, has been identified in patients with type 1 and type 2 diabetes receiving sodium glucose co-transporter 2 (SGLT2) inhibitors, including STEGLATRO. Some cases were fatal. In placebo-controlled trials of patients with type 1 diabetes, the risk of ketoacidosis was increased in patients who received SGLT2 inhibitors compared to patients who received placebo. The risk of ketoacidosis may be greater with higher doses. Assess patients with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If ketoacidosis is suspected, discontinue STEGLATRO, evaluate, treat promptly, and ensure risks for ketoacidosis are resolved prior to restarting. Before initiating, consider risk factors. Consider temporarily discontinuing STEGLATRO for at least 4 days prior to scheduled surgery. Monitor patients and temporarily discontinue STEGLATRO in clinical situations known to predispose to ketoacidosis (e.g., prolonged fasting due to acute illness or post-surgery). Educate patients on the signs and symptoms of ketoacidosis. Instruct patients to discontinue STEGLATRO and seek medical attention immediately if signs and symptoms occur.
Lower Limb Amputations: In a long-term cardiovascular outcomes study, in patients with type 2 diabetes and established cardiovascular disease, the occurrence of non-traumatic lower limb amputations was higher with ertugliflozin compared to placebo. Amputation of the toe and foot were most frequent (81 out of 109 patients with lower limb amputations). Some patients had multiple amputations, some involving both lower limbs. Lower limb infections, gangrene, and diabetic foot ulcers were the most common precipitating medical events leading to the need for an amputation. Patients with amputations were more likely to be male, have higher A1C (%) at baseline, have a history of peripheral arterial disease, amputation or peripheral revascularization procedure, diabetic foot, and to have been taking diuretics or insulin. Across seven Phase 3 clinical trials with STEGLATRO, non-traumatic lower limb amputations were reported in 1 (0.1%) patient in the comparator group, 3 (0.2%) patients in the STEGLATRO 5 mg group, and 8 (0.5%) patients in the STEGLATRO 15 mg group. Before initiating STEGLATRO, consider factors that may predispose patients to the need for amputations. Monitor patients and discontinue STEGLATRO if complications occur. Counsel patients about the importance of routine preventative foot care.
Volume Depletion: STEGLATRO can cause intravascular volume contraction which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors, including STEGLATRO. Patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, patients with low systolic blood pressure, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating STEGLATRO in these patients, assess volume status and renal function. Correct volume depletion before initiating STEGLATRO. Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy.
Urosepsis and Pyelonephritis: There have been postmarketing reports of serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization in patients receiving SGLT2 inhibitors. Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Insulin and insulin secretagogues (e.g., sulfonylurea) are known to cause hypoglycemia. STEGLATRO may increase the risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with STEGLATRO.
Necrotizing Fasciitis of the Perineum (Fournier's Gangrene): A rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention has been identified in postmarketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors, including STEGLATRO. Serious outcomes have included hospitalization, multiple surgeries, and death. Patients treated with STEGLATRO presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise, should be assessed for necrotizing fasciitis. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue STEGLATRO, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.
Genital Mycotic Infections: STEGLATRO increases the risk of genital mycotic infections. Patients who have a history of genital mycotic infections or who are uncircumcised are more likely to develop these infections. Monitor and treat appropriately.
The most common adverse reactions associated with STEGLATRO (≥5%) were female genital mycotic infections.
Before prescribing STEGLATRO® (ertugliflozin), please read the accompanying Prescribing Information. The Medication Guide also is available.
