Amongst sufferers with kind 2 diabetes who had poor glycemic management with metformin remedy, weekly dulaglutide resulted in clinically related weight reduction and glycated hemoglobin (HbA1c) discount. These findings, from a randomized, double-blind, parallel-arm research, have been printed in Diabetes Care.
Sufferers (N=1842) with kind 2 diabetes mellitus have been recruited from 203 websites in 15 nations for the Evaluation of Weekly Administration of LY2189265 in Diabetes-11 (AWARD-11) trial. Sufferers have been randomly assigned in a 1:1:1 ratio to obtain 1.5 (n=612), 3.0 (n=616), or 4.5 (n=614) mg weekly dulaglutide subcutaneous injection for a 2-week lead-in interval after which therapy for 52 weeks adopted by a 4-week security evaluation. Randomization occurred after stratifying sufferers by low (<8.5%) or excessive (³8.5%) HbA1c. All sufferers have been initiated on once-weekly 0.75 mg dulaglutide for 4 weeks, after which the dose was escalated to the randomized dose. Efficacy and security have been assessed.
Sufferers had a imply age of 57.1 (±10.0) years, and 48.8% have been girls. Sufferers had been identified a mean of seven.6 (±5.7) years in the past, their baseline HbA1c was 8.6% (±1.0%), and their physique mass index was 34.2 (±6.3) kg/m2.
At 36 weeks, the least-square imply change of HbA1c was -1.54%, -1.64%, and -1.77% for the low-, intermediate-, and high-dose teams, respectively. Sufferers within the 4.5-mg group confirmed the best enchancment of HbA1c, which was important in contrast with the 1.5-mg group (estimated therapy distinction [ETD], -0.24%; 95% CI, -0.36% to -0.11%; P <.001).
In contrast with the low-dose group, sufferers receiving 4.5 mg have been extra more likely to have lower than 7% (odds ratio [OR], 2.2; 95% CI, 1.7-3.0; P <.001) or 6.5% or much less (OR, 2.0; 95% CI, 1.5-2.6; P <.001) change of HbA1c at 36 weeks.
Physique weight was considerably decreased among the many 3.0-mg (ETD, -0.9; 95% CI, -1.4 to -0.4 kg; P =.001) and 4.5-mg (ETD, -1.6; 95% CI, -2.1 to -1.1 kg; P <.001) teams in contrast with the 1.5-mg cohort at 36 weeks.
Among the many low-, intermediate-, and high-dose recipients, the most typical opposed occasions have been nausea (14.2% vs 16.1% vs 17.3%), diarrhea (7.7% vs 12.0% vs 11.6%), and vomiting (6.4% vs 9.1% vs 10.1%), which brought about nearly all of drug discontinuations. Severe occasions (8.3% vs 6.8% vs 6.2%) and loss of life (0.5% vs 0.6% vs 0.7%) have been uncommon.
The outcomes of this research is probably not generalizable amongst a inhabitants of sufferers with kind 2 diabetes who will not be chubby or have superior glycemic management on metformin.
The research authors concluded 3.0 or 4.5 mg weekly subcutaneous injections of dulaglutide favorably lowered HbA1c concentrations and weight amongst sufferers with kind 2 diabetes and poor glycemic management with out elevated situations of great opposed occasions in contrast with the well-established dose of 1.5 mg dulaglutide.
Disclosure: A number of authors declared affiliations with business. Please check with the unique article for a full checklist of disclosures.
Frias J P, Bonora E, Ruiz L N, et al. Efficacy and security of dulaglutide 3.0 mg and 4.5 mg versus dulaglutide 1.5 mg in metformin-treated sufferers with kind 2 diabetes in a randomized managed trial (AWARD-11). Printed on-line January 4, 2021. Diabetes Care. doi:10.2337/dc20-1473