Fixed-dose combination of ertugliflozin and sitagliptin (Steglujan) for the treatment of type 2 diabetes

Introduction

The fixed-dose combination of ertugliflozin and sitagliptin (trade name: Steglujan) has been approved in Germany since March 2018 for the treatment of type 2 diabetes in adults who can’t control their blood sugar levels enough through diet and exercise alone.

Diabetes is a metabolic disease that affects many different parts of the body. In type 2 diabetes, the initially does produce enough insulin, but the body’s cells gradually lose the ability 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.

The aim of this treatment is to avoid strong fluctuations in blood sugar levels and prevent problems caused by high and low blood sugar in people with diabetes. A further goal of this treatment is to prevent long-term complications that may arise if blood sugar levels are too high.

This fixed-dose combination of drugs is suitable for people who do not benefit enough from taking one of the commonly used sulfonylureas or metformin, and also for people who are already taking sitagliptin and ertugliflozin as separate tablets. The aim of treatment for type 2 diabetes is to avoid strong fluctuations in blood sugar levels and prevent 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 of ertugliflozin and sitagliptin are available as tablets in two doses: One tablet contains 100 mg of sitagliptin and either 5 mg or 15 mg of ertugliflozin. The dose used will depend on the 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 medicines include metformin, empagliflozin, liraglutide, sulfonylurea and insulin.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether the fixed-dose combination of ertugliflozin and sitagliptin has any advantages or disadvantages compared to 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 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 ertugliflozin and sitagliptin (Steglujan).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ertugliflozin/sitagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A18-31. September 6, 2018. (IQWiG reports; Volume 657).

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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Created on September 6, 2018
Next planned update: 2021

Authors/Publishers:

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

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