Trulicity Overview
*Across clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose; the percentage of patients achieving A1C <7% ranged from 37% to 69% for 0.75 mg and 53% to 78% for 1.5 mg.1-5
Therapeutic indications: Trulicity is indicated in adults with type 2 diabetes mellitus to improve glycaemic control as:
Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.
Add-on therapyIn combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control
MonotherapyThe recommended dose is 0.75 mg once weekly.
Add-on therapy The recommended dose is 1.5 mg once weekly.
For potentially vulnerable populations, such as patients ≥ 75 years, 0.75 mg once weekly can be considered
as a starting dose.
When Trulicity is added to existing metformin and/or pioglitazone therapy, the current dose of metformin
and/or pioglitazone can be continued. When it is added to existing therapy of a sulphonylurea or prandial
insulin, a reduction in the dose of sulphonylurea or insulin may be considered to reduce the risk of
hypoglycaemia
Method of Administration: Trulicity is to be injected subcutaneously in the abdomen, thigh or upper arm. It should not be administered intravenously or intramuscularly. The dose can be administered at any time of day, with or without meals.
Contraindication: Hypersensitivity to the active substance or to any of the excipients. Also in patients with a personal or family history of MTC “medullary thyroid carcinoma“ and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) .
Undesirable Effects: The most frequently reported adverse reactions in clinical trials were gastrointestinal, including nausea, vomiting and diarrhoea. In general these reactions were mild or moderate in severity and transient in nature.
For more information, please refer to the full Summary of Product Characteristics