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FDA approved Xigduo XR (dapagliflozin/metformin) for Type 2 Diabetes and Related IndicationsFDA approved new combination pill Xigduo XR for type 2 diabetes

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Key Takeaway
Consider Xigduo XR for type 2 diabetes glycemic control and for dapagliflozin's cardiovascular and kidney risk reduction in eligible adults.

The FDA has approved Xigduo XR (dapagliflozin and metformin HCl extended-release) as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. The combination tablet also carries additional indications for dapagliflozin when used as a component of Xigduo XR in adults with type 2 diabetes, including reducing 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; reducing cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in patients with heart failure; and reducing hospitalization for heart failure in patients with type 2 diabetes and either established cardiovascular disease or multiple cardiovascular risk factors.

This approval provides a fixed-dose combination option that may improve adherence by combining an SGLT2 inhibitor with extended-release metformin in a once-daily oral tablet. The label emphasizes that Xigduo XR is not recommended for glycemic control in type 1 diabetes and is limited to type 2 diabetes due to the metformin component. Clinicians should assess renal function and volume status before initiating therapy, and adjust dosing based on the patient's current regimen and renal function.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

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

Indication & Patient Population

Xigduo XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Additionally, dapagliflozin, when used as a component of Xigduo XR, is indicated in adults with type 2 diabetes 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 and either established cardiovascular disease or multiple cardiovascular risk factors. Limitations of use: not recommended for glycemic control in type 1 diabetes; limited to type 2 diabetes due to metformin component; not recommended for treatment of chronic kidney disease in patients with polycystic kidney disease or those requiring or with recent history of immunosuppressive therapy for kidney disease.

Dosing & Administration

Assess renal function and volume status before initiating. Correct volume depletion before starting. Individualize starting dose based on current treatment. Administer orally once daily in the morning with food. Swallow tablets whole; do not crush, cut, or chew. For glycemic control in patients aged 10 years and older not already taking dapagliflozin, recommended starting dose of dapagliflozin is 5 mg once daily. For heart failure and chronic kidney disease indications in adults, recommended dapagliflozin dose is 10 mg once daily. Maximum daily dose is 10 mg dapagliflozin/2,000 mg metformin HCl extended-release. In patients with eGFR ≥45 mL/min/1.73 m², dosing is same as normal renal function; initiation is not recommended in patients with eGFR below this level (per label). May need to discontinue at time of or prior to iodinated contrast imaging; withhold for at least 3 days before surgery or procedures associated with prolonged fasting.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label. (Note: The label text provided does not include a dedicated Warnings and Precautions section. Clinicians should consult the full prescribing information for comprehensive safety information.)

Place in Therapy

Xigduo XR combines an SGLT2 inhibitor with extended-release metformin, offering a once-daily option for glycemic control in type 2 diabetes. It also provides a way to deliver dapagliflozin for additional cardiovascular and kidney risk reduction in appropriate adult patients. It is not recommended for type 1 diabetes or for chronic kidney disease in patients with polycystic kidney disease or recent immunosuppressive therapy.

The U.S. Food and Drug Administration has approved a new medicine called Xigduo XR for people with type 2 diabetes. This pill combines two common diabetes drugs: dapagliflozin and extended-release metformin. It is taken once a day and is meant to be used along with diet and exercise to improve blood sugar control. The approval covers adults and children aged 10 years and older with type 2 diabetes.

Xigduo XR is not just for blood sugar. In adults, the dapagliflozin part of the pill has additional approved uses. It can help reduce the risk of serious kidney problems, heart failure, and related hospitalizations in certain patients. Specifically, it is approved for adults with chronic kidney disease who are at risk of getting worse, for adults with heart failure, and for adults with type 2 diabetes who have heart disease or are at high risk for it.

This approval is important because it offers a fixed-dose combination in one pill. That may make it easier for patients to stick to their treatment plan, since they only need to take one tablet instead of two separate medicines. However, the drug is not recommended for people with type 1 diabetes, and it is only for type 2 diabetes because of the metformin component.

Before starting Xigduo XR, doctors should check kidney function and fluid status. The dose will depend on what the patient is already taking and how well their kidneys work. As with any medicine, patients should talk to their doctor about whether Xigduo XR is right for them and what side effects to watch for.

What this means for you:
Xigduo XR is a new once-daily pill for type 2 diabetes that also helps protect the heart and kidneys in some adults.

Study Details

Study typeFda approval
PublishedOct 2014
View Original Abstract ↓
1 INDICATIONS AND USAGE XIGDUO XR is a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Dapagliflozin, when used as a component of XIGDUO XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: • Sustained eGFR decline, end‑stage kidney disease, (CV) death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. • CV death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure. • Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. Limitations of Use • XIGDUO XR is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2) ] . • Because of the metformin HCl component, the use of XIGDUO XR is limited to patients with type 2 diabetes mellitus for all indications. • XIGDUO XR is 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. XIGDUO XR is not expected to be effective in these populations. XIGDUO XR is a combination of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. ( 1 ) Dapagliflozin when used as a component of XIGDUO XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: • Sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. ( 1 ) • CV death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure. ( 1 ) • Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. ( 1 ) Limitations of use : • Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 ) • Because of the metformin HCl component, the use of XIGDUO XR is limited to patients with type 2 diabetes mellitus for all indications. ( 1 ) • 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 the treatment of kidney disease. XIGDUO XR is not expected to be effective in these populations. ( 1 )
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