Fixed-dose combination of dapagliflozin and metformin (Xigduo) for the treatment of type 2 diabetes

Introduction

The fixed-dose combination of the active ingredients dapagliflozin and metformin (trade name: Xigduo) has been approved in Germany since January 2014 for the treatment of type 2 diabetes in adults who can't lower their blood sugar levels enough through diet and exercise alone.

Diabetes is a metabolic disease that affects many parts of the body. In type 2 diabetes, the still produces enough insulin at first, but the body’s cells gradually lose the ability to absorb and use the insulin. If blood sugar levels cannot be lowered enough by changes in diet and exercise habits, blood-sugar-lowering medications are used.

The combination is suitable for people in whom metformin alone isn't helping enough or for people who already take dapagliflozin and metformin as separate tablets. It can also be used together with other blood-sugar-lowering drugs, including insulin, if metformin and those drugs are not enough.

Application

The fixed-dose combination dapagliflozin / metformin is taken twice daily as a tablet. One tablet contains 5 mg of dapagliflozin and 850 mg or 1,000 mg of metformin, depending on how high the previous dose of metformin was. If this fixed-dose combination is taken together with other blood-sugar-lowering tablets or insulin, their dosages may have to be adjusted by a doctor to prevent hypoglycemia.

Other treatments

Various medications are available for the treatment of type 2 diabetes in adults. They can either be used alone or in combination with each other, and include metformin, sulphonylureas and insulin.

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) last looked into whether dapagliflozin / metformin has any advantages or disadvantages when compared with the standard treatments.

But the manufacturer did not provide any suitable data with which to do the assessment.

More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of these reviews and the hearings received, the G-BA passed a resolution on the added benefit of the fixed-dose combination dapagliflozin / metformin(Xigduo).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Dapagliflozin/metformin – Benefit assessment according to § 35a Social Code Book V. Dossier assessment; Commission A14-07. May 12, 2014. (IQWiG reports; Volume 220).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Dapagliflozin/metformin (type 2 diabetes mellitus) – Benefit assessment according to § 35a Social Code Book V. Dossier assessment; Commission A17-66. March 28, 2018. (IQWiG reports; Volume 611).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany) . Dapagliflozin/metformin (type 2 diabetes mellitus) – Benefit assessment according to § 35a Social Code Book V. Dossier assessment; Commission A19-52. September 27, 2019. (IQWiG reports; Volume 819).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Updated on October 18, 2019
Next planned update: 2022

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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