March 28, 2016
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Trulicity reduces HbA1c, body weight in type 2 diabetes

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Adults with type 2 diabetes assigned the glucagon-like peptide-1 receptor agonist Trulicity experienced dose-dependent reductions in body weight and HbA1c over 26 weeks; however, the relationship between weight loss and HbA1c reduction was weak, according to an analysis of the six AWARD trials.

Guillermo E. Umpierrez, MD, professor of medicine in the division of endocrinology, metabolism at Emory University School of Medicine, and colleagues analyzed data from 5,171 adults with type 2 diabetes participating in one of the six randomized controlled AWARD trials, ranging from 26 to 104 weeks. All studies evaluated the safety and efficacy of Trulicity (dulaglutide, Eli Lilly and Company) and were designed to assess superiority of dulaglutide vs. placebo or noninferiority of dulaglutide vs. active comparators. Researchers analyzed the trials separately due to differences in design and background therapies, using data at 26 weeks, and evaluated the effect of baseline characteristics on weight and HbA1c response.

Within the cohort, 1,719 participants were assigned 1.5 mg dulaglutide; 1,417 were assigned 0.75 mg. Across studies, between 87% and 97% of participants assigned 1.5 mg dulaglutide saw a reduction in HbA1c; between 83% and 95% of participants assigned 0.75 mg saw an HbA1c reduction. Between 57% and 88% of participants assigned 1.5 mg dulaglutide lost weight; between 43% and 84% of participants assigned 0.75 mg lost weight. Between 55% and 83% of participants assigned 1.5 mg dulaglutide experienced both weight loss and a reduction in HbA1c, whereas 41% to 79% of participants assigned 0.75 mg experienced both. Researchers noted a weak and inconsistent correlation between changes in body weight and HbA1c (correlation coefficient range, –0.223 to 0.267) in participants assigned dulaglutide.

“In the additional pooled analyses, as expected by the individual study results, we found weak correlation coefficient values of 0.254 and 0.237 upon combining monotherapy and add-on-to-metformin studies and no correlations upon combining studies with concomitant therapies associated with weight gain,” the researchers wrote. “This finding helps explain the variations in correlations between studies with different background therapies.”

Sex, age, duration of diabetes, HbA1c, body weight and BMI were not related to different combinations of weight and HbA1c responses, according to researchers. – by Regina Schaffer

Disclosure: Eli Lilly and Company sponsored this study. Umpierrez reports receiving past research grant support, consulting fees or honoraria from AstraZeneca, Boehringer Ingelheim, Merck, Novo Nordisk, Regeneron and Sanofi. Please see the full study for the other authors’ relevant financial disclosures.