Introduction

The fixed-dose combination of insulin glargine / lixisenatide (trade name: Suliqua) has been approved in Germany since January 2017 for the treatment of type 2 diabetes in adults. It is used in addition to metformin if metformin alone or in combination with other medications does not provide adequate control of blood sugar levels.

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

The fixed-dose combination of insulin glargine / lixisenatide helps to prevent strong fluctuations in blood sugar levels and the unpleasant effects of high and low blood sugar. It can also help to prevent the complications that may develop if blood sugar levels are too high.

Application

The active ingredients insulin glargine / lixisenatide are injected under the skin using a pre-filled pen once daily, one hour before a meal. The dose prescribed will depend on a number of factors, including previous 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 drugs such as metformin, empagliflozin, liraglutide or human insulin. These can either be used on their own (monotherapy) or in combination with each other.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether the fixed combination of insulin glargine / lixisenatide has advantages or disadvantages compared to the standard treatments.

The manufacturer provided one study involving a total of 544 people with usable data. These people had been unable to sufficiently control their blood sugar levels using metformin in combination with another blood-sugar-lowering tablet. In the study, half the participants received the fixed-dose combination insulin glargine / lixisenatide in addition to metformin. The other half received metformin and insulin glargine. The following results were found after about 30 weeks of treatment:

What are the advantages of insulin glargine / lixisenatide?

  • No advantages were found compared with the standard treatment.

What are the disadvantages of insulin glargine / lixisenatide?

  • Gastrointestinal diseases: Here the study suggests that insulin glargine / lixisenatide has a disadvantage. In the group that received the fixed-dose combination, about 23 out of 100 people experienced symptoms such as diarrhea, nausea or vomiting. In the group that received insulin glargine, this happened in about 12 out of 100 people.

No difference

  • Life expectancy: Over the course of the study, a total of 3 people passed away.
  • Complications of diabetes: Complications such as heart attacks or strokes were very rare in both groups.
  • Serious side effects: About 4 out of 100 people in each group had severe side effects.
  • There was no difference between the treatments in terms of the following aspects either:
    • General health
    • Treatment stopped due to side effects
    • Severe and moderate hypoglycemia
    • Kidney dysfunction

What remains unanswered?

  • The manufacturer didn't provide any suitable data about health-related quality of life.

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 this review and the hearings received, the G-BA passed a resolution on the added benefit of the fixed-dose combination insulin glargine / lixisenatide (Suliqua).