Dulaglutide, a GLP-1 receptor agonist, is indicated as monotherapy for the treatment of type 2 diabetes in patients intolerant to metformin. It is also indicated in combination with other antidiabetics, including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
Trulicity is administered once weekly. Trulicity is available in both 1.5 mg and 0.75 mg doses to be injected using a pre-filled ready-to-use injection pen with a hidden needle. The lower dose of 0.75 mg will, however, not be marketed before the end of 2015.
The clinical studies conducted over 26-52 weeks demonstrated dulaglutide to be just as effective or superior to the comparator products in lowering of HbA1c, when used as mono-therapy or in combination with other antidiabetics or insulin. Studies are presently being conducted on hard endpoints such as micro- and macro-vascular complications as well as reduction of mortality. However, no data are available yet.
The most common adverse reactions are nausea, vomiting and diarrhoea. Incidents of hypoglycaemia have been observed at rates varying with the diabetic treatment given concurrently with dulaglutide. The occurrence of severe hypoglycaemia was higher in combination with either insulin or a sulphonylurea. Like other GLP-1 analogues, dulaglutide is suspected to increase the risk of acute pancreatitis.
It is IRF’s overall assessment that no clear clinical advantages have been demonstrated to recommend dulaglutide over any of the other GLP-1 analogues, which are all considered of equal standing. However, it is possible that 1.5 mg dulaglutide has an efficacy advantage over exenatide.
Thus, there is no logical first-line agent within this group, and the choice of GLP-1 analogue should be based on an individual assessment of risk factors, patient profile and preferences, practical matters as well as the price of treatment.
Trulicity was marketed on 27 April 2015. Unlike the other GLP-1 analogues, Trulicity has not been granted general conditional reimbursement, and only single reimbursement may be applied for.