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Trulicity is licensed for the treatment of type II diabetes when diet and exercise provide inadequate glycaemic control. It can be used as monotherapy when metformin is inappropriate, or in combination with other glucose-lowering medicinal products, including insulin, when these alone are inadequate.1
PHARMACOLOGY
Further information
View Trulicity drug record
Manufacturer details
Dulaglutide is a long-acting GLP-1 receptor agonist. It improves glycaemic control by lowering fasting, pre-meal and postprandial glucose concentrations. The antihyperglycaemic effect starts after the first dose and is sustained throughout the once-weekly dosing interval, as a result of the prolonged half-life of 4.7 days.1
CLINICAL STUDIES
The safety and efficacy of dulaglutide were evaluated in six randomised, controlled, phase III trials involving 5,171 patients with type II diabetes. The primary endpoint in all studies was mean change in HbA1c.1
Monotherapy (AWARD-3)
Treatment with dulaglutide monotherapy (1.5mg once weekly) resulted in an HbA1c reduction of -0.78% at week 26 compared with a reduction of -0.56% for metformin (1.5–2g daily). Once-weekly dulaglutide at either dose (750 microgram and 1.5mg) was superior to metformin in terms of HbA1c reduction at 26 weeks (p<0.0025 for both).2
Vs sitagliptin (AWARD-5)
Another study compared dulaglutide 1.5mg and 750 microgram with sitagliptin 100mg daily in metformin-treated patients with inadequate glycaemic control. At week 52, both dulaglutide doses produced superior glycaemic control to sitagliptin, with mean HbA1c reductions of 1.1% and 0.87% versus 0.39%, respectively (p.0.001 for both comparisons).3
Vs liraglutide (AWARD-6)
In a non-inferiority study, patients with inadequately controlled diabetes receiving metformin (≥1.5g/day) were randomly assigned to receive once-weekly dulaglutide 1.5mg (n=299) or once-daily liraglutide 1.8mg (n=300). Dulaglutide showed non-inferiority to liraglutide for HbA1c reduction at week 26.4
With metformin and sulfonylurea
Dulaglutide was compared with insulin glargine in patients receiving metformin and a sulfonylurea. Dulaglutide 1.5mg was superior to insulin glargine in lowering HbA1c at week 52 and the benefit was maintained until trial end (78 weeks). In addition, dulaglutide 750 microgram was non-inferior to insulin glargine.1
With metformin and pioglitazone (AWARD-1)
When added to metformin and pioglitazone, dulaglutide at doses of both 1.5mg and 750 microgram showed superiority to placebo and twice-daily exenatide for HbA1c reduction at 26 weeks.5
With prandial insulin (AWARD-2)
Patients were randomised to dulaglutide once weekly or insulin glargine once daily, both in combination with prandial insulin lispro three times daily, with or without metformin. At 26 weeks, both doses of dulaglutide were superior to insulin glargine in lowering HbA1c.1
Safety profile
The most commonly reported adverse effects of dulaglutide were nausea, vomiting and diarrhoea.1
Hypoglycaemia
The incidence of symptomatic hypoglycaemia in patients treated with dulaglutide was 0.14-0.62 events per patient per year when used as monotherapy, in combination with metformin or with metformin plus pioglitazone.1
Higher rates of symptomatic hypoglycaemia were observed when dulaglutide was given in combination with a sulfonylurea plus metformin or prandial insulin. As with other GLP-1 agonists, prescribers adding dulaglutide to a patient's regimen may need to reduce the dose of concomitant sulfonylurea or insulin, to reduce the risk of hypoglycaemia.1
References
