Higher-dose dulaglutide reduces HbA1c, body weight in type 2
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Adults with poorly controlled type 2 diabetes assigned higher, investigational doses of the GLP-1 receptor agonist dulaglutide experienced greater improvements in glycemic response and body weight compared with those assigned the currently approved dose of 1.5 mg weekly, with no new safety signals observed, according to findings from the AWARD-11 trial published in the Journal of the Endocrine Society.

Data from 1,842 adults with type 2 diabetes inadequately controlled with metformin therapy (mean age, 57 years; mean diabetes duration, 7.6 years; mean HbA1c, 8.6%; mean BMI, 34.2 kg/m²), randomly assigned once-weekly dulaglutide 1.5 mg (Trulicity, Eli Lilly; n = 612), dulaglutide 3 mg (n = 616) and dulaglutide 4.5 mg (n = 614) for 36 weeks was analysed. All participants initiated once-weekly dulaglutide 0.75 mg for 4 weeks, followed by a stepwise dose escalation every 4 weeks to the randomized dose of 1.5 mg, 3 mg or 4.5 mg.

Using the efficacy estimand, researchers found that the 3 mg and 4.5 mg doses of dulaglutide were superior to the 1.5 mg dose for change in HbA1c from baseline. Mean reductions from baseline were 1.53% for the 1.5 mg dose, 1.71% for the 3 mg dose and 1.87% for the 4.5 mg dose.

The percentage of participants achieving an HbA1c of 7% across study groups was 57% for the 1.5 mg group, 65% for the 3 mg group and 71% for the 4.5 mg group. Mean body weight reductions from baseline were 3.1 kg for the 1.5 mg group, 4 kg for the 3 mg group and 4.7 kg for the 4.5 mg group.

Using the treatment-regimen estimand, each of the doses led to HbA1c and body weight reductions; however, only the 4.5 mg dose showed superiority compared with the 1.5 mg dose, according to researchers.

Source: https://academic.oup.com/jes/article/4/Supplement_1/OR26-08/5833134?searchresult=1
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