Xigduo - dapagliflozin, metformin

What is Xigduo and what is it used for - dapagliflozin, metformin?

Xigduo is a medicine containing the active substances dapagliflozin and metformin. It is used as an adjunct to diet and exercise to control blood glucose (sugar) levels in adult patients with type 2 diabetes mellitus not adequately controlled on metformin alone; it is also used in combination with other medicines. antidiabetics, including insulin, when these medicines, in combination with metformin, do not provide adequate control of diabetes. Xigduo can also be used as a replacement for dapagliflozin and metformin taken as separate tablets.

How is Xigduo used - dapagliflozin, metformin?

Xigduo is available as tablets (5 mg dapagliflozin / 850 mg metformin and 5 mg dapagliflozin / 1 000 mg metformin) and can only be obtained with a prescription. The recommended dose is one tablet twice a day, with meals. The dosage should be chosen so that patients receive a total daily dose of the medicinal product equivalent to dapagliflozin 10 mg in addition to the metformin dose (or the nearest therapeutically appropriate dose) already administered. When Xigduo is used in combination with insulin, your doctor may decide to lower the insulin dose to reduce the risk of hypoglycaemia (low blood glucose).

How does Xigduo work - dapagliflozin, metformin?

Type 2 diabetes is a disease in which the pancreas does not produce enough insulin to control blood glucose levels or in which the body is unable to use insulin effectively, which leads to increased levels blood glucose. Xigduo contains two different active ingredients, each with a different mechanism of action:

  • dapagliflozin works by blocking a protein found in the kidneys called sodium-glucose cotransporter type 2 (SGLT2). SGLT2 is a protein responsible for the reabsorption of glucose into the bloodstream (bloodstream) from urine, when the blood is filtered into the kidneys. By blocking the action of SGLT2, dapagliflozin induces the elimination of more glucose through the urine and, as a result, the reduction in the concentration of glucose in the blood. Dapagliflozin was authorized in the European Union (EU) under the name of Forxiga in 2012;
  • metformin works primarily by inhibiting the production of glucose and reducing its absorption in the intestine. It has been available in the EU since the 1950s.

Thanks to the combined action of the two active ingredients, the blood glucose rate is reduced and this serves to control type 2 diabetes.

What benefit has Xigduo - dapagliflozin, metformin shown during the studies?

Dapagliflozin, in combination with metformin, was evaluated in 6 main studies involving 3,200 adults with type 2 diabetes. Most of these data had already been used in the Forxiga application for authorization. In one main study when used at a dose of 5 mg twice daily in combination with metformin (in the same combination as Xigduo), dapagliflozin decreased HbA1c levels by 0.65% compared to 0.30% seen in the placebo group (a dummy treatment) and metformin after 16 weeks. HbA1c (glycosylated hemoglobin) is a substance in the blood that gives an indication of how well the blood glucose is controlled. The other two studies showed that dapagliflozin taken with metformin and another antidiabetic medicine (sitagliptin or insulin) for 24 weeks further reduced HbA1c levels: compared to the combination of placebo and metformin, the combination of dapagl iflozin and metformin induced a reduction in HbA1c levels of 0.40% more when combined with sitagliptin and 0.61% more when combined with insulin. Further studies confirmed that different combinations of dapagliflozin and metformin decreased HbA1c levels more than combinations of placebo and comparable doses of metformin, and that compared to the antidiabetic drug glipizide (a type of medicine known as a sulphonylurea) the combination of dapagliflozin and metformin did demonstrated at least equal efficacy in reducing HbA1c levels. In a sixth study, it was found that after 24 weeks of treatment, patients taking dapagliflozin plus metformin had a weight loss of approximately 2 kg more than those taking placebo and metformin.

What is the risk associated with Xigduo - dapagliflozin, metformin?

The most common side effects with Xigduo (which may affect more than 1 in 10 people) are hypoglycaemia (if the medicine is used in combination with insulin or a sulphonylurea) and gastrointestinal symptoms (stomach and bowel symptoms). For the full list of all side effects reported with Xigduo, see the package leaflet. Xigduo is contraindicated in patients administered to:

  • diabetic ketoacidosis (increased blood levels of a type of acid called "ketones") or diabetic pre-coma (a dangerous condition that can occur in people with diabetes);
  • reduced liver function;
  • moderate or severe changes in kidney function or acute conditions that could alter kidney function, including dehydration, severe infection or shock;
  • diseases that can cause tissue hypoxia (decreased oxygen levels in body tissues);
  • alcoholism.

For the full list of restrictions, see the package leaflet.

Why has Xigduo - dapagliflozin, metformin been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Xigduo's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted that Xigduo is effective in controlling the blood glucose levels and which also induces weight loss, which is considered an advantage in diabetic patients. The CHMP also noted that the administration of the combination of dapagliflozin and metformin in a "single tablet could represent an" additional therapeutic option for people with type 2 diabetes and improve adherence to therapy. Regarding the safety profile, it was considered similar to the safety profile of dapagliflozin.

What measures are being taken to ensure the safe and effective use of Xigduo - dapagliflozin, metformin?

A risk management plan has been developed to ensure that Xigduo is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Xigduo, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Xigduo - dapagliflozin, metformin

On 16.01.2014 the European Commission granted a "Marketing Authorization" for Xigduo, valid throughout the European Union. For more information on therapy with Xigduo, read the package leaflet (included with the EPAR) or consult your doctor or the pharmacist. Last update of this summary: 01-2014.

The information on Xigduo - dapagliflozin, metformin published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.

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