FDA Approves Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets for Type 2 Diabetes and Related Risks
The FDA has approved a new combination tablet of dapagliflozin and metformin hydrochloride extended-release for use in adults with type 2 diabetes mellitus. The approval, dated April 6, 2026, covers its use as an adjunct to diet and exercise to improve glycemic control. The dapagliflozin component carries additional indications to reduce the risk of major adverse cardiovascular and renal outcomes in specific high-risk patients, including those with chronic kidney disease, heart failure, or established cardiovascular disease or multiple risk factors. This approval provides a once-daily, fixed-dose combination option that integrates glycemic management with potential organ-protective benefits for qualifying patients. The label includes specific limitations, noting the combination is not recommended for patients with type 1 diabetes, polycystic kidney disease, or those requiring recent immunosuppressive therapy for kidney disease.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Dapagliflozin and metformin hydrochloride extended-release tablets are a combination of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and metformin hydrochloride, a biguanide.
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The dapagliflozin component, when used as part of this combination, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: sustained eGFR decline, end-stage kidney disease, cardiovascular death and hospitalization for heart failure in patients with chronic kidney disease at risk of progression; cardiovascular death, hospitalization for heart failure and urgent heart failure visit in patients with heart failure; and hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. Because of the metformin HCl component, use is limited to patients with type 2 diabetes mellitus for all indications. Not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease, as it is not expected to be effective in these populations.
Assess renal function and volume status prior to initiation; correct volume depletion before starting. Individualize the starting dosage based on the patient's current treatment. Administer orally once daily in the morning with food; swallow whole and never crush, cut, or chew. For improving glycemic control in patients not already taking dapagliflozin, the recommended starting dosage for dapagliflozin is 5 mg once daily. For indications related to heart failure and chronic kidney disease, the recommended dosage of dapagliflozin is 10 mg once daily. Do not exceed a daily dosage of 10 mg dapagliflozin/2000 mg metformin HCl extended-release. The label instructs to consult the Full Prescribing Information for dosage in renal impairment. The tablets may need to be discontinued at the time of, or prior to, iodinated contrast imaging procedures. Withhold for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting.
Trial data not available in label.
Not reported in label.
Not reported in label.
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