This article is more than 5 years old. Information may no longer be current.
Add-on oral ertugliflozin may delay progression to injection therapies in type 2 diabetes
Click Here to Manage Email Alerts
Ertugliflozin added to metformin and sitagliptin therapy in adults with type 2 diabetes was safe and effective for reducing HbA1c levels, according to findings from the VERTIS SITA2 study.
“Current American Diabetes Association guidelines for treatment of patients with type 2 diabetes recommend lifestyle modification plus metformin at diagnosis,” Samuel Dagogo-Jack, MD, an Endocrine Today Editorial Board member from the University of Tennessee Health Science Center in Memphis, told Endocrine Today. “If control is not established by 3 months, the recommendation is to add a second drug to metformin, and to further add a third drug if two drugs fail to control diabetes. In many patients requiring triple therapy for diabetes control, an injectable drug has traditionally been part of the regimen. Few clinical trials have rigorously tested the efficacy of triple oral agents on diabetes. The introduction of SGLT2 inhibitors provided an opportunity for conducting such a study.”
Dagogo-Jack and colleagues evaluated data from VERTIS SITA2 on 464 adults (mean age, 59.1 years) with type 2 diabetes prescribed both metformin (≥ 1,500 mg per day) and sitagliptin (100 mg per day; Januvia, Merck) randomly assigned to add-on ertugliflozin (Merck/Pfizer) 5 mg per day, ertugliflozin 15 mg per day or placebo. The primary outcome was change in HbA1c at 26 weeks; the study was continued until week 52.
HbA1c changes from baseline to week 26 were greater in the ertugliflozin groups compared with the placebo group (P < .001 for both comparisons). HbA1c less than 7% was achieved by 39.9% of participants in the 15-mg group, 32.1% in the 5-mg group and 17% in the placebo group. From baseline to week 26, greater reductions in fasting plasma glucose, body weight and systolic blood pressure were observed in the ertugliflozin groups compared with the placebo group. At week 52, changes in HbA1c, FPG, body weight and systolic BP were sustained.
Incidences of serious adverse events and adverse events that led to discontinuation of medication were low and similar across the treatment groups. For 26 weeks, incidences of symptomatic hypoglycemia, hypoglycemia and hypovolemia were low and similar across the three groups.
“The VERTIS SITA2 study tested triple oral therapy with metformin, sitagliptin and ertugliflozin vs. placebo in patients who were inadequately controlled with two drugs,” Dagogo-Jack said. “The randomized controlled design and the multicenter geographical dispersal sites make this quite a robust study. Patients whose diabetes is inadequately controlled with two oral agents have fairly refractory diabetes. Many such patients have historically been considered candidates for insulin injection. Thus, the findings of 0.8% reduction in HbA1c and ADA target achievement in nearly 40% of patients, following addition of a third oral agent, is impressive and somewhat surprising.” – by Amber Cox
For more information:
Corresponding author Brett Lauring, ME, PhD, can be reached at brett_lauring@merck.com.
Disclosures: Dagogo-Jack reports he is a principal investigator/co-investigator for clinical trials contracts to the University of Tennessee from AstraZeneca, Boehringer Ingelheim and Novo Nordisk; and serves as a consultant and is on the advisory board for Amgen, AstraZeneca, Boehringer Ingelheim, Janssen Pharmaceuticals, Kenilworth, Merck, Novo Nordisk and Sanofi. Please see the study for all other authors’ relevant financial disclosures.
Click Here to Manage Email Alerts