Long-acting diabetes drug dulaglutide launches in UK
A new type II diabetes medicine dulaglutide (Trulicity) has been launched in the UK this week.
The drug is a GLP-1 receptor agonist and works as a once-weekly, injectable solution designed to improve glycaemic control in adults with type 2 diabetes.
The treatment was given European approval in December and has now been launched by the drug’s manufacturer Lilly. It will soon be added to NICE’s appraisal list and will likely receive its first round of draft guidance in the next three months.
The new licence sees the drug used in combination with other glucose-lowering medicines, including insulin, when these together with diet and exercise do not provide adequate glycaemic control.
It can also be used as a 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.
Dulaglutide 1.5mg once-weekly is recommended for those taking the drug in combination with other diabetes treatments.
The lower dose dulaglutide 0.75mg once-weekly is the recommended dose for patients taking it as monotherapy and can be considered as a starting dose (in combination with other diabetes treatments) for certain vulnerable populations, including patients aged 75 years of age and older.
The marketing authorisation is based, in part, on results from a number of studies, including six large Phase III clinical trials.
In the first five trials, the higher dose form of the drug was superior to placebo and four commonly used type 2 diabetes medicines in reducing average HbA1c levels.
The lower 0.75mg provided similar HbA1c reductions in one of the trials, and demonstrated superiority in the other four. In the sixth trial, dulaglutide 1.5mg showed similar HbA1c reductions to the highest approved dose of a commonly used once-daily GLP-1 receptor agonist.
The most frequently reported adverse events were gastrointestinal-related and, when used in combination with mealtime insulin or metformin plus glimepiride, documented symptomatic hypoglycaemia. These adverse events are consistent with those seen with other GLP -1 receptor agonists.
The launch means patients with type II diabetes now have an alternative to modified release exenatide (Bydureon), which has been available as a weekly injection in the UK for a number of years.
It will also compete with liraglutide [rDNA origin] injection (Victoza), which was the first GLP-1 one medicine to be to be NICE-approved for reducing HbA1c levels, although it must be taken daily.
But whether the second-in-class dulaglutide proves to be popular with patients will be down to whether the pen is easier to use than its UK market competitor.
Lilly has been keen to ensure its product does well, and says it has conducted new research among 500 people with type II diabetes which it says “uncovers some common misconceptions around what an injected treatment means for them”.
Its study found that 84% of those surveyed believe that an injectable medication is a sign that their diabetes is getting worse, and 66% believe that injected medications are inconvenient.
Debbie Hicks, a nurse consultant in diabetes in Barnet, Enfield & Haringey Mental Health Trust, said: “Once oral medications are no longer providing adequate control, healthcare professionals may consider an injectable therapy as part of a long-term plan.
“Anxiety about needles is something many GPs and diabetes nurse specialists hear from patients, but options are now available that can help make the injection experience more convenient and less stressful.
“In fact, once patients have made the sometimes difficult step to move onto injectable medicines, most people find that the process becomes second nature.”