This article is more than 5 years old. Information may no longer be current.
Ertugliflozin improves glycemic control, body weight, without adverse bone effects
Click Here to Manage Email Alerts
Adults with poorly controlled type 2 diabetes assigned the SGLT2 inhibitor ertugliflozin along with metformin therapy saw reductions in HbA1c and body weight over 26 weeks, with no adverse effect on bone mineral density in the overall cohort or among postmenopausal women, study data show.
“With both doses of ertugliflozin, decreases in HbA1c were clinically relevant and consistent with reports for other SGLT2 inhibitors,” Julio Rosenstock, MD, director of the Dallas Diabetes Research Center at Medical City, and colleagues wrote. “Treatment with ertugliflozin also resulted in significant improvements relative to placebo in other glycemic measures, including FPG, and in the proportion of patients with an HbA1c < 7%.”
Rosenstock and colleagues analyzed data from 621 adults with type 2 diabetes and HbA1c between 7% and 10.5% inadequately controlled with metformin monotherapy (46.4% men; mean age, 57 years; mean diabetes duration, 8 years). After a 2-week placebo run-in period, researchers randomly assigned participants to 5 mg or 15 mg daily ertugliflozin (Merck/Pfizer) or placebo for 26 weeks. Participants were stratified into four groups: men, premenopausal women, women who were perimenopausal or postmenopausal for no more than 3 years, and women who were postmenopausal for at least 3 years. A 78-week extension is ongoing. Primary endpoint was change from baseline in HbA1c at week 26; secondary endpoints included change from baseline at week 26 in fasting plasma glucose, body weight, systolic and diastolic blood pressure and the proportion of participants with HbA1c 7% or less. Percent changes from baseline in BMD and adverse events were also assessed.
At 26 weeks, researchers observed HbA1c reductions in both ertugliflozin groups over placebo (P < .001). Compared with placebo, the placebo-adjusted least-squares mean change from baseline in HbA1c was –0.7% (95% CI, –0.9 to –0.5) for the 5-mg ertugliflozin dose and –0.9% for the 15-mg dose (95% CI, –1 to –0.7), with a final mean HbA1c of 7.3% and 7.2%, respectively, in both ertugliflozin groups.
Ertugliflozin also reduced FPG, body weight and BP vs. placebo, according to researchers. However, as with other SGLT2 inhibitors, the incidence of genital mycotic infections was increased in the ertugliflozin groups vs. placebo. Among women, 5.5% in the 5-mg dose group and 6.3% in the 15-mg dose group experienced genital mycotic infections compared with 0.9% of women in the placebo group. Among men, 3.1% in the 5-mg dose group and 3.2% in the 15-mg dose group experienced genital mycotic infections vs. no men in the placebo group. Overall adverse events were similar between groups, according to researchers.
Researchers observed no adverse effect on BMD at week 26; three participants — one in each group — had adjudication-confirmed fractures.
The researchers also noted small increases in HDL and LDL cholesterol with ertugliflozin, consistent with reports of other SGLT2 inhibitors. SGLT2 inhibitors have also been associated with transient increases in serum creatinine and decreases in estimated glomerular filtration rate. In this study, there was an initial decrease in eGFR at week 6 in both ertugliflozin groups; however, by week 26, values returned to baseline and were similar to placebo. – by Regina Schaffer
Disclosures: Pfizer and Merck funded this study. Engage Scientific, funded by Pfizer, provided editorial support. Please see the study for the authors’ relevant financial disclosures.
Click Here to Manage Email Alerts