Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The VERTIS FACTORIAL randomized trial Article

Industry Collaboration International Collaboration

cited authors

  • Pratley, Richard E., Eldor, Roy, Raji, Annaswamy, Golm, Gregory, Huyck, Susan B., Qiu, Yanping, Sunga, Sheila, Johnson, Jeremy, Terra, Steven G., Mancuso, James P., Engel, Samuel S., Lauring, Brett

funding text

  • Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NewJersey, in collaboration with Pfizer Inc.

abstract

  • Aim: To evaluate the efficacy and safety of ertugliflozin and sitagliptin co-administration vs the individual agents in patients with type 2 diabetes who are inadequately controlled with metformin. Methods: In this study (Clinicaltrials.gov NCT02099110), patients with glycated haemoglobin (HbA1c) >= 7.5% and <= 11.0% (>= 58 and <= 97 mmol/mol) with metformin >= 1500 mg/d (n = 1233) were randomized to ertugliflozin 5 (E5) or 15 (E15) mg/d, sitagliptin 100 mg/d (S100) or to coadministration of E5/S100 or E15/S100. The primary endpoint was change from baseline in HbA1c at Week 26. Results: At Week 26, least squares mean HbA1c reductions from baseline were greater with E5/S100 (-1.5%) and E15/S100 (-1.5%) than with individual agents (-1.0%, -1.1% and -1.1% for E5, E15 and S100, respectively; P<.001 for all comparisons). HbA1c<7.0% (<53 mmol/mol) was achieved by 26.4%, 31.9%, 32.8%, 52.3% and 49.2% of patients in the E5, E15, S100, E5/S100 and E15/S100 groups, respectively. Fasting plasma glucose reductions were significantly greater with E5/S100 and E15/S100 compared with individual agents. Body weight and systolic blood pressure (SBP) significantly decreased with E5/S100 and E15/S100 vs S100 alone. Glycaemic control, body weight and SBP effects of ertugliflozin were maintained to Week 52. Genital mycotic infections were more common among ertugliflozin-treated patients compared with those treated with S100. Incidences of symptomatic hypoglycaemia and adverse events related to hypovolaemia or urinary tract infection were similar among groups. Conclusions: In patients with uncontrolled type 2 diabetes while using metformin, coadministration of ertugliflozin and sitagliptin provided more effective glycaemic control through 52 weeks compared with the individual agents.

authors

Publication Date

  • May 1, 2018

webpage

published in

category

start page

  • 1111

end page

  • 1120

volume

  • 20

issue

  • 5

WoS Citations

  • 12

WoS References

  • 27