What is Suliqua - Insulin glargine - Lixisenatide and what is it used for?
Suliqua is a medicine used together with metformin (another antidiabetes medicine) for the treatment of adults with type 2 diabetes. It is used when the levels of glucose (sugar) in the blood are not adequately controlled by metformin alone or by a combination of metformin with another medicine (another hypoglycemic medicine taken orally or a long-acting insulin).
The active ingredients of Suliqua are insulin glargine and lixisenatide
How is Suliqua used - Insulin glargine - Lixisenatide?
Suliqua is available as prefilled disposable pens in two different dosages and can only be obtained with a prescription. It is given by subcutaneous injection in the abdomen, thigh or upper arm.
Suliqua is given once a day, preferably at the same time. Before starting treatment with Suliqua, the patient's insulin and anti-diabetic medicines other than metformin must be discontinued. The dose is individually adapted to each patient. To find the minimum effective dosage the blood glucose level of the patient must be regularly monitored.
For more information, see the package leaflet.
How does Suliqua - Insulin glargine - Lixisenatide work?
Type 2 diabetes is a disease in which the level of glucose in the blood is high because the body does not produce enough insulin or because it is unable to use insulin effectively.
One of the active ingredients present in Suliqua, insulin glargine, is a replacement insulin that has the same mechanisms of action as the insulin naturally produced by the body and promotes the penetration of glucose into the cells from the blood, thereby controlling its blood level. After the injection, insulin glargine enters the bloodstream more slowly than human insulin and its action is therefore longer lasting.
The other active ingredient in Suliqua, lixisenatide, belongs to the group of antidiabetic medicines called GLP-1 agonists. It acts in a similar way to GLP-1 (a hormone produced in the intestine) by increasing the amount of insulin released by the pancreas in response to food. In this way it helps control blood glucose levels.
By controlling the level of glucose in the blood, the symptoms of diabetes are reduced and complications are avoided
What benefit has Suliqua - Insulin glargine - Lixisenatide shown during the studies?
Suliqua has been shown to be effective in blood glucose control in two main studies involving 1 906 patients with type 2 diabetes. In both studies the main measure of effectiveness was the change, after 30 weeks of treatment, in the blood concentration of a substance called glycosylated hemoglobin (HbA1c), which provides an indication of the effectiveness of blood glucose control.
The first study involved 1 170 patients in whom blood glucose was not adequately controlled by metformin in combination or not with other oral antidiabetic medicines. By participating in the study, all patients had to stop treatment with other antidiabetic medicines and took Suliqua or insulin glargine or lixisenatide, all with metformin. The results showed that Suliqua is more effective in controlling blood glucose levels than either component: mean HbA1c at the beginning of the study was 8.1%, after 30 weeks of treatment it decreased to 6, 5% in the Suliqua group, compared to 6.8% in the insulin glargine group and 7.3% in the lixisenatide group. A reduction in HbA1c levels means an improvement in the control of blood sugar levels.
The second study involved 736 patients in whom blood glucose was not adequately controlled with a long-acting insulin such as insulin glargine or not with one or two oral antidiabetic medicines. Patients involved in the study had to stop all treatments with orally administered medicines, except metformin, and were then treated with Suliqua or insulin glargine. Before patients started taking Suliqua or insulin glargine, the average HbA1c was 8.1%. After 30 weeks of treatment, mean HbA1c decreased to 6.9% in the Suliqua group and 7.5% in insulin glargine patients.
What are the risks associated with Suliqua - Insulin glargine - Lixisenatide?
The most common side effect of Suliqua (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose); digestive system problems are common and include diarrhea, vomiting and nausea. For the full list of all side effects reported with Suliqua and its limitations, see the package leaflet.
Why has Suliqua - Insulin glargine - Lixisenatide been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Suliqua's benefits are greater than its risks and recommended that it be approved for use in the EU.
The CHMP concluded that treatments in combination with a long-acting insulin and a GLP-1 agonist such as Suliqua constitute an important treatment option for patients who are eligible for insulin intake or who require a intensive insulin therapy. In these patients, Suliqua was effective in controlling glucose levels and reduced the risk of problems related to intensive insulin therapy such as hypoglycemia and weight gain. In terms of safety, no new problems emerged regarding the association of insulin glargine and lixisenatide in Suliqua compared to the components used separately.
What measures are being taken to ensure the safe and effective use of Suliqua - Insulin glargine - Lixisenatide?
The company that markets Suliqua will provide healthcare professionals and patients with informational materials containing clarifications on how to use the medicine safely in order to reduce the risk of medication errors.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Suliqua have also been included in the summary of product characteristics and the package leaflet.
Further information on Suliqua - Insulin glargine - Lixisenatide
On 11 January 2017, the European Commission issued a marketing authorization for Suliqua, valid throughout the European Union.
For the full EPI of Suliqua, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Suliqua therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 12-2016.
