diabetes drugs

Trulicity - dulaglutide

What is Trulicity - dulaglutide and what is it used for?

Trulicity is an antidiabetic medicine used in adult patients with type 2 diabetes mellitus to control the level of glucose (sugar) in the blood. Trulicity can be used as the only therapy when diet and exercise alone do not provide adequate control of blood glucose levels in patients who cannot take metformin (another antidiabetic medicine). Trulicity can also be used as an adjunctive therapy in combination with other antidiabetic medicines, including insulin, when these medicines, together with diet and exercise, do not provide adequate blood glucose control. Trulicity contains the active ingredient dulaglutide.

How is Trulicity - dulaglutide used?

Trulicity is available in pre-filled pens (0.75 mg and 1.5 mg) containing a solution for subcutaneous injection. The medicine can only be obtained with a prescription. Patients self-administer the medicine (after being properly trained) by subcutaneous injection in the abdomen or thigh. The recommended dose is 0.75 mg once a week if the medicine is used on its own and 1.5 mg once a week if it is used as combination therapy (although your doctor may start with the lowest dose in patients potentially more at risk, such as those over 75 years of age). If the medicine is used in combination with a type of antidiabetic medicine called a sulphonylurea or with insulin, it may be necessary to reduce the dose of the sulphonylurea or insulin in order to avoid hypoglycaemia (low blood glucose concentration). For more information, see the package leaflet.

How does Trulicity - dulaglutide work?

Type 2 diabetes is a disease in which the pancreas does not produce enough insulin to control the level of glucose in the blood or where the body is unable to use insulin effectively. The active substance in Trulicity, dulaglutide, is a "GLP-1 receptor agonist". It works by attaching to the receptors of a substance, called the glucagon-like peptide 1 (GLP-1), which are found on the surface of pancreatic cells, stimulating them to release insulin. After the Trulicity injection, dulaglutide reaches the receptors in the pancreas, activating them. This causes the release of insulin and helps reduce blood glucose levels and control type 2 diabetes.

What benefit has Trulicity - dulaglutide shown during the studies?

The benefits of Trulicity were examined in 5 main studies involving over 4 500 patients with type 2 diabetes mellitus. In these studies, Trulicity was compared with placebo (a dummy treatment) or with other antidiabetic medicines used on its own. or as an additional medicine in various combination therapies. Information from a sixth study, which was presented during the procedure, was also considered. The main measure of effectiveness was the change in the level of glycosylated hemoglobin (HbA1c), the percentage of hemoglobin in the blood that binds to glucose. HbA1c gives an indication of the effectiveness of blood glucose control. The mean HbA1c of patients at baseline was between 7.6% and 8.5% and patients were treated for at least 52 weeks. Trulicity was more effective than metformin in reducing HbA1c levels when used as monotherapy; moreover, it was more effective than exenatide antidiabetic medicines (given twice a day) or sitagliptin, as well as at least comparable to insulin glargine, when used as an adjunctive therapy to other treatments. After 26 weeks of treatment, Trulicity reduced HbA1c by 0.71-1.59% at the lowest dose and 0.78-1.64% at the highest dose. This is considered to be clinically significant. The benefits have been shown to have been maintained during a long-term treatment. Approximately 51% of patients treated with the lowest dose and 60% of patients treated with the highest dose of Trulicity achieved a target HbA1c value of less than 7.0%, a better result in general than those achieved with treatments alternative.

What is the risk associated with Trulicity - dulaglutide?

The most common side effects with Trulicity (which may affect more than 1 in 10 people) are nausea, vomiting and diarrhea. For the full list of all side effects and restrictions with Trulicity, see the package leaflet.

Why has Trulicity - dulaglutide been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Trulicity's benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee noted that the medicinal product, when used in combination with other drugs, produces a significant and clinically relevant effect in the control of blood glucose. The medicine was more effective when given at the weekly dose of 1.5 mg instead of 0.75 mg. However, if used in monotherapy in patients who cannot take metformin, or if given in very elderly subjects (over 75 years of age), the benefit / risk ratio was better with the lower dose. As for safety, the effects of prolonged use and safety in vulnerable groups of the population such as very old patients should be monitored, but no particularly alarming specific aspects have emerged and the risks are considered similar to those of other medicines belonging to this class. Furthermore, Trulicity has the advantage of being given once a week.

What measures are being taken to ensure the safe and effective use of Trulicity - dulaglutide?

A risk management plan has been developed to ensure that Trulicity is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Trulicity, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.

More information on Trulicity - dulaglutide

On 21 November 2014, the European Commission issued a marketing authorization for Trulicity, valid throughout the European Union. For more information about treatment with Trulicity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 11-2014.