Introduction

Sitagliptin (trade name: Januvia or Xelevia) has been approved in Germany since March 2007 for the treatment of type 2 diabetes in adults who can't lower their blood sugar levels enough through exercise and diet alone. It can be combined with other blood-sugar-lowering drugs such as metformin, sulfonylurea or insulin, and is also an option if metformin is not well tolerated.

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

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

Sitagliptin is taken once a day in tablet form at a dose of 100 mg. If sitagliptin is combined with sulfonylurea, metformin or insulin, their doses may have to be adjusted to prevent hypoglycemia.

Other treatments

Type 2 diabetes can be treated with a number of different medicines, either used alone or in combination with each other. These medicines include metformin, sulfonylureas and insulin.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) last looked into whether sitagliptin has any advantages or disadvantages compared with the standard treatments – when sitagliptin is used alone or in combination with metformin, sulfonylureas or insulin.

The only relevant data provided by the manufacturer was taken from studies comparing the combination sitagliptin/metformin with the combination sulfonylurea/metformin. In these studies, sitagliptin/metformin was either compared with glimepiride/metformin or with glipizide/metformin.

The manufacturer also provided IQWiG with the results of the TECOS study. But the data from this study wasn't suitable for answering the questions addressed by the IQWiG researchers.

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Research summaries

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 the reviews and the hearings received, the G-BA passed a resolution on the added benefit of sitagliptin (Januvia or Xelevia).