What is Suliqua - Insulin glargine - Lixisenatide and what is it used for?
Suliqua is a medicine used together with metformin (another diabetes medicine) to treat adults with type 2 diabetes. It is used when blood glucose (sugar) levels are not adequately controlled by metformin alone or by a 'combination of metformin with another medicine (another blood glucose lowering medicine taken by mouth or a' long-acting 'insulin).
The active substances in Suliqua are insulin glargine and lixisenatide
How is Suliqua - Insulin glargine - Lixisenatide used?
Suliqua is available as single-use pre-filled pens in two different strengths and can only be obtained with a prescription. It is given by injection under the skin 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 antidiabetic medicines other than metformin should be discontinued. The dose is individually adjusted for each patient. The patient's blood glucose level should be regularly monitored to find the lowest effective dose. .
For more information, see the package leaflet.
How does Suliqua - Insulin glargine - Lixisenatide work?
Type 2 diabetes is a disease in which the blood glucose level is high because the body does not make 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 produced naturally by the body" and promotes the penetration of glucose into cells from the blood, thus controlling its blood level. After injection, insulin glargine enters the bloodstream more slowly than human insulin and therefore its action is longer lasting.
The other active substance in Suliqua, lixisenatide, belongs to the group of antidiabetic medicines called GLP-1 agonists. It works in a similar way to GLP-1 (a hormone produced in the gut) by increasing the amount of insulin released by the pancreas in response. to food. In doing so, it promotes the control of 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 was shown to be effective in controlling blood glucose in two main studies involving 1,906 patients with type 2 diabetes. In both studies, the main measure of effectiveness was the change in the blood concentration of a substance called glycosylated hemoglobin (HbA1c), which gives an 'indication of how well the blood glucose is controlled.
The first study involved 1,170 patients whose blood glucose was not adequately controlled by metformin in combination or not with other antidiabetic medicines taken by mouth. Participating in the study, all patients had to stop their 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 both components: the mean HbA1c at the start of the study was 8.1%, after 30 weeks of treatment it decreased to 6, 5% in the Suliqua group, compared with 6.8% in the insulin glargine group and 7.3% in the lixisenatide group A reduction in HbA1c levels means an improvement in blood sugar control.
The second study involved 736 patients whose blood glucose was not adequately controlled on a "long-acting insulin such as insulin glargine in combination or not with one or two antidiabetic medicines taken by mouth. The patients in the study all had to stop. treatments with oral medications, except metformin, and were then treated with Suliqua or insulin glargine. Before patients started taking Suliqua or insulin glargine, mean HbA1c was 8.1%. At 30 weeks of treatment, mean HbA1c decreased to 6.9% in the Suliqua group and to 7.5% in patients taking insulin glargine.
What are the risks associated with Suliqua - Insulin glargine - Lixisenatide?
The most common side effect with 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 side effects reported with Suliqua and their restrictions, 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 are an" important treatment option for patients who are eligible to take insulin or who need an 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. combination of insulin glargine and lixisenatide in Suliqua versus 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 educational materials explaining how to use the medicine safely in order to reduce the risk of medication errors.
The recommendations and precautions to be observed by healthcare professionals and patients for Suliqua to be used safely and effectively have also been reported in the summary of product characteristics and package leaflet.
More information about Suliqua - Insulin glargine - Lixisenatide
On 11 January 2017, the European Commission issued a "marketing authorization" for Suliqua, valid throughout the European Union.
For the complete version of Suliqua's EPAR, 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 (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 12-2016.
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