Introduction

The fixed-dose combination 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.

As of March 2020, insulin glargine / lixisenatide has also been approved for use in people who take a flozin (SGLT-2 inhibitor) in addition to metformin. Flozins cause more sugar to leave the body in urine, lowering blood sugar levels.

Diabetes is a metabolic disease that affects many 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 through a change in diet and exercise habits, blood-sugar-lowering medication is used.

The fixed-dose combination 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 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) last looked into whether the fixed-dose combination of insulin glargine / lixisenatide has any advantages or disadvantages compared to the standard treatments.

The manufacturer didn't provide any studies in which patients had treatment with metformin and a flozin. So it was not possible to find out whether insulin glargine / lixisenatide has any advantages or disadvantages for people who are taking a flozin in addition to metformin.

In 2018 the manufacturer provided one study from which it was possible to use the data of 544 people. The blood sugar levels in these people were not controlled well enough with metformin in combination with another blood-sugar-lowering tablet besides a flozin. 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 the fixed-dose combination insulin glargine / lixisenatide?

  • There were no advantages compared to the standard treatment.

What are the disadvantages of insulin glargine / lixisenatide?

  • Gastrointestinal diseases: The study suggests that insulin glargine / lixisenatide has a disadvantage here. In the group that received this 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.
  • Severe 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:
    • Overall health
    • Treatment stopped due to side effects
    • Severe and non-severe hypoglycemia
    • Kidney dysfunction

What remains unanswered?

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

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 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).