The fixed combination insulin degludec / liraglutide (trade name: Xultophy) has been approved in Germany since September 2014 for the treatment of type 2 diabetes in adults. It is injected in addition to other blood-glucose lowering drugs if they do not provide adequate control of blood sugar levels.
Diabetes is a metabolic disease that affects many parts of the body. In type 2 diabetes, the pancreas can produce enough insulin at first, but the body’s cells gradually lose the ability to absorb and use it. If blood sugar levels cannot be lowered sufficiently through a change in diet and exercise habits, medication is used.
The combination of long-acting insulin degludec and liraglutide is intended to regulate blood sugar levels. The aim of treatment is to avoid strong fluctuations in blood sugar levels and the effects of high and low blood sugar in diabetes. It also aims to prevent complications that can result from blood sugar levels being too high.
Insulin degludec / liraglutide is injected once a day using a pre-filled pen. The individual dose depends on a number of factors including additional blood-sugar-reducing therapy, blood sugar levels and the targeted blood sugar level. It has to be adjusted individually.
Type 2 diabetes can be treated with a number of different blood-sugar lowering drugs such as metformin and insulin. These can either be used on their own (monotherapy) or in combination with each other.
In two reviews produced in 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the possible advantages and disadvantages of the drug combination insulin degludec /liraglutide for adults with type 2 diabetes when combined with oral blood-sugar-lowering drugs in comparison with conventional treatment.
One of the reviews focused on people whose blood sugar levels could not be sufficiently regulated by taking blood-sugar-lowering drugs, either on their own or in combination with basal insulin. The other review looked at people who were not sufficiently able to regulate their blood sugar levels by taking blood-sugar-lowering drugs in combination with incretin mimetics.
The manufacturer did not provide suitable data for either of the groups. It was therefore not possible to assess the advantages and disadvantages of the fixed combination of insulin degludec and liraglutide.
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, G-BA passed a resolution on the added benefit of insulin degludec / liraglutide (Xultophy).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Insulin degludec / liraglutide – Benefit assessment according to §35a Social Code Book V. Dossier assessment A15-15. Cologne: IQWiG. July 30, 2015.
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Insulin degludec / liraglutide (Addendum to Commission A15-15). Dossier assessment A15-36. Cologne: IQWiG. September 24, 2015.
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Insulin degludec / liraglutide (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V. Dossier assessment A15-30. Cologne: IQWiG. November 11, 2015.
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