Introduction

The fixed-dose combination of empagliflozin and linagliptin (trade name: Glyxambi) has been approved in Germany since November 2016 for the treatment of type 2 diabetes in adults who can’t control their blood sugar levels enough through diet, exercise and two other blood-sugar-lowering drugs.

Diabetes is a metabolic disease that affects many parts of the body. In type 2 diabetes, the pancreas initially does produce enough insulin, but the cells of the body become increasingly unable to absorb and use it. If blood sugar levels can’t be lowered enough through changes in diet and exercise habits, blood-sugar-lowering drugs are used.

Treatment with this fixed-dose combination of empagliflozin and linagliptin is suitable for people who don’t benefit enough from taking one of the commonly used sulfonylureas or metformin, and also for people who are already taking empagliflozin and linagliptin separately. The aim of this treatment in type 2 diabetes is to avoid strong fluctuations in blood sugar levels and the effects of high and low blood sugar. A further goal of this treatment is to prevent long-term complications that may arise if blood sugar levels are too high.

Application

The fixed-dose combination is available in tablet form, in two different doses: Each tablet contains either 10 or 25 mg of empagliflozin and 5 mg of linagliptin. The tablets are taken once a day. The dose depends on the person's blood sugar levels.

Other treatments

Type 2 diabetes can be treated with a number of different medicines, either taken alone or in combination with each other. These medications include metformin, empagliflozin, liraglutide, sulfonylurea and insulin.

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to look into the advantages and disadvantages of empagliflozin / linagliptin when compared with the standard treatments.

But the manufacturer didn’t 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 the fixed-dose combination of empagliflozin and linagliptin (Glyxambi).