Trulicity
Authorised
This medicine is authorised for use in the European Union
dulaglutide
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Trulicity is a medicine used in adults and children from 10 years of age with type 2 diabetes. It is used in addition to appropriate diet and exercise.
Trulicity is used:
- on its own when use of metformin (another medicine for type 2 diabetes) is not recommended;
- as an ‘add-on’ to other diabetes medicines.
Trulicity contains the active substance dulaglutide.
Trulicity can only be obtained with a prescription. It is available as prefilled pens containing a solution to be injected under the skin in the abdomen (belly), in the thigh or in the upper arm.
For more information about using Trulicity, see the package leaflet or contact your doctor or pharmacist.
The active substance in Trulicity, dulaglutide, is a ‘GLP-1 receptor agonist’. It acts in the same way as GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food. This helps to control blood glucose levels and symptoms of type 2 diabetes.
In adults, the effectiveness of Trulicity has been studied in 5 main studies involving over 4,500 patients with type 2 diabetes. In these studies, Trulicity was compared with placebo (a dummy treatment) or with other diabetes medicines when used alone or as an add-on to various combination treatments. Information from a supportive study sent with the application was also considered.
The main measure of effectiveness was the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached to it. HbA1c gives an indication of how well blood glucose is controlled. The patients’ HbA1c at baseline ranged from 7.6 to 8.5% and patients were treated for at least 52 weeks.
Trulicity was more effective than metformin at reducing HbA1c levels when used alone, and it was more effective than the diabetes medicines exenatide (given twice daily) or sitagliptin, and at least as good as insulin glargine, when used as add-on to other treatments.
After 26 weeks of treatment, Trulicity reduced HbA1c by between 0.71 and 1.59 percentage points at the lower dose, and by between 0.78 and 1.64 percentage points at the higher dose. This was considered clinically meaningful and there was evidence that HbA1c levels remained low during long-term treatment. About 51% of those given the lower dose and 60% of patients given the higher dose of Trulicity achieved a target HbA1c below 7.0% and this was generally more than the proportion achieving this target with alternative treatments.
A further study in 9,901 adults with type 2 diabetes found Trulicity effective at reducing major harmful effects on the heart and the circulatory system. Stroke, heart attack or death from heart of circulatory problems occurred in 12.0% of patients receiving Trulicity over about 5 years compared with 13.4% of patients receiving placebo.
The benefits of Trulicity were also investigated in one main study involving 154 children from 10 years of age with type 2 diabetes. After 26 weeks of treatment, patients on Trulicity had a reduction in HbA1c levels of 0.7 percentage points, versus an increase of 0.6 percentage points for patients on placebo. This difference between Trulicity and placebo was considered clinically meaningful.
The most common side effects with Trulicity (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting and diarrhoea. For the full list of side effects and restrictions of Trulicity, see the package leaflet.
The European Medicines Agency decided that Trulicity’s benefits are greater than its risks and it can be authorised for use in the EU. The medicine was effective for treating type 2 diabetes: it improved control of blood sugar levels in adults and children from 10 years of age and was shown to reduce harmful effects on the heart and blood circulation in adults. In addition, Trulicity has the advantage that it can be given once a week. The medicine’s side effects are considered manageable.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trulicity have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Trulicity are continuously monitored. Side effects reported with Trulicity are carefully evaluated and any necessary action taken to protect patients.
Trulicity received a marketing authorisation valid throughout the EU on 21 November 2014.
Product information
Latest procedure affecting product information:
IAIN/0072
27/09/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Trulicity
- Active substance
- dulaglutide
- International non-proprietary name (INN) or common name
- dulaglutide
- Therapeutic area (MeSH)
- Diabetes Mellitus, Type 2
- Anatomical therapeutic chemical (ATC) code
- A10BJ05
Pharmacotherapeutic group
- Drugs used in diabetes
- Blood glucose lowering drugs, excl. insulins
Therapeutic indication
Trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
- in addition to other medicinal products for the treatment of diabetes.
For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
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