Introduction

The fixed combination of empagliflozin and metformin (trade name: Synjardy) has been approved in Germany since May 2015 for the treatment of type 2 diabetes in adults who cannot control their blood sugar levels enough through exercise and diet alone.

Diabetes is a metabolic disease that affects many parts of the body. In type 2 diabetes, the pancreas can produce enough insulin at first, but the body’s cells gradually lose the ability to absorb and use it. If blood sugar levels cannot be lowered sufficiently through a change in diet and exercise habits, blood sugar lowering medication is used.

The combination is suitable for people who do not benefit enough from taking metformin alone and for people who are already taking empagliflozin and metformin as separate tablets. The combination can also be used with other blood-sugar-lowering drugs, including insulin, if metformin and those drugs are not enough.

The treatment aims to avoid strong fluctuations in blood sugar levels and prevent problems caused by high and low blood sugar. A further goal of this treatment is to help prevent the development of long-term complications that can arise if your blood sugar levels are too high.

Application

Empagliflozin / metformin is taken twice daily as a tablet. The drug is available in the following doses:

  • 5 mg empagliflozin / 850 mg metformin
  • 5 mg empagliflozin / 1000 mg metformin
  • 12.5 mg empagliflozin / 850 mg metformin
  • 12.5 .g empagliflozin / 1,000 mg metformin

The individual dose prescribed will depend on a number of factors, including additional blood-sugar-lowering treatment, blood sugar levels and the target blood sugar level. It has to be adjusted individually.

Other treatments

Type 2 diabetes can be treated with a number of different blood-sugar-lowering medicines, either taken alone or together. These drugs include metformin, sulfonylurea and insulin.

Assessment

In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of empagliflozin / metformin compared with the standard therapies for people with type 2 diabetes.

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

More information

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