TY - JOUR
T1 - Efficacy and Safety of Ertugliflozin in Patients with Type 2 Diabetes Inadequately Controlled by Metformin and Sulfonylurea
T2 - A Sub-Study of VERTIS CV
AU - Budoff, Matthew J.
AU - Davis, Timothy M.E.
AU - Palmer, Alexandra G.
AU - Frederich, Robert
AU - Lawrence, David E.
AU - Liu, Jie
AU - Gantz, Ira
AU - Derosa, Giuseppe
N1 - Funding Information:
This study was sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA in collaboration with Pfizer Inc., New York, NY, USA. Journal rapid service fees were funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA in collaboration with Pfizer Inc., New York, NY, USA.
Funding Information:
Medical writing support was provided by Diane Hoffman, PhD, of Engage Scientific Solutions and was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, in collaboration with Pfizer Inc., New York, NY, USA.
Funding Information:
Alexandra G. Palmer, Robert Frederich, and David E. Lawrence are employees of Pfizer and own stock and/or stock options in Pfizer Inc., New York, NY, USA. Jie Liu and Ira Gantz are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD) and may own stock in Merck & Co., Inc., Kenilworth, NJ, USA. Matthew J. Budoff received grant support from MSD and Pfizer Inc related to the VERTIS CV trial, and has received speaker fees from Pfizer Inc. Timothy M.E. Davis has served on advisory boards for, and received research funding, speaker fees, and travel assistance to attend meetings from, MSD; he was a VERTIS CV local investigator; and has served on advisory boards for, and received speaker fees and travel assistance to attend meetings from, AstraZeneca, Boehringer Ingelheim, and Novo Nordisk. Giuseppe Derosa has nothing to disclose.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021
Y1 - 2021
N2 - Introduction: VERTIS CV is the cardiovascular outcome trial for the sodium–glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin. A sub-study was conducted to assess the efficacy and safety of ertugliflozin in patients with type 2 diabetes mellitus (T2DM) inadequately glycemic-controlled on metformin and a sulfonylurea (SU). Methods: Patients with T2DM, established atherosclerotic cardiovascular disease (ASCVD), and an HbA1c of 7.0–10.5% on stable metformin (≥ 1500 mg/day) and moderate to high SU doses were randomly assigned to once-daily ertugliflozin (5 or 15 mg) or placebo. The primary sub-study objectives were to assess the effect of ertugliflozin on HbA1c compared with placebo and to evaluate safety following 18 weeks of treatment. Key secondary endpoints included changes in fasting plasma glucose (FPG), body weight (BW), blood pressure (BP), and the proportion of patients achieving HbA1c < 7%. Results: Of the 8246 patients enrolled in VERTIS CV, 330 were eligible for this sub-study (ertugliflozin 5 mg, n = 100; ertugliflozin 15 mg, n = 113; placebo, n = 117). This subgroup had a mean (SD) age of 63.2 (8.4) years and T2DM duration of 11.4 (7.4) years. At week 18, ertugliflozin 5 mg and 15 mg were each associated with significantly greater least squares (LS) mean reductions from baseline in HbA1c relative to placebo (placebo-adjusted LS mean [95% CI] − 0.66% [− 0.89, − 0.43] and − 0.75% [− 0.98, − 0.53], respectively, p < 0.001 for each dose vs placebo). Ertugliflozin significantly reduced FPG and BW compared with placebo (p < 0.001), but not systolic BP. Adverse events were reported in 48.0%, 54.9%, and 47.0% of patients in the ertugliflozin 5 mg and 15 mg, and placebo groups. The incidences of symptomatic hypoglycemia were 11.0% (5 mg), 12.4% (15 mg), and 7.7% (placebo), and of severe hypoglycemia 2.0% (5 mg), 1.8% (15 mg), and 0.9% (placebo). Conclusions: In patients with T2DM and ASCVD, ertugliflozin added to metformin and SU improved glycemic control, reduced BW, and was generally well tolerated. Trial Registration: VERTIS CV ClinicalTrials.gov identifier, NCT01986881.
AB - Introduction: VERTIS CV is the cardiovascular outcome trial for the sodium–glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin. A sub-study was conducted to assess the efficacy and safety of ertugliflozin in patients with type 2 diabetes mellitus (T2DM) inadequately glycemic-controlled on metformin and a sulfonylurea (SU). Methods: Patients with T2DM, established atherosclerotic cardiovascular disease (ASCVD), and an HbA1c of 7.0–10.5% on stable metformin (≥ 1500 mg/day) and moderate to high SU doses were randomly assigned to once-daily ertugliflozin (5 or 15 mg) or placebo. The primary sub-study objectives were to assess the effect of ertugliflozin on HbA1c compared with placebo and to evaluate safety following 18 weeks of treatment. Key secondary endpoints included changes in fasting plasma glucose (FPG), body weight (BW), blood pressure (BP), and the proportion of patients achieving HbA1c < 7%. Results: Of the 8246 patients enrolled in VERTIS CV, 330 were eligible for this sub-study (ertugliflozin 5 mg, n = 100; ertugliflozin 15 mg, n = 113; placebo, n = 117). This subgroup had a mean (SD) age of 63.2 (8.4) years and T2DM duration of 11.4 (7.4) years. At week 18, ertugliflozin 5 mg and 15 mg were each associated with significantly greater least squares (LS) mean reductions from baseline in HbA1c relative to placebo (placebo-adjusted LS mean [95% CI] − 0.66% [− 0.89, − 0.43] and − 0.75% [− 0.98, − 0.53], respectively, p < 0.001 for each dose vs placebo). Ertugliflozin significantly reduced FPG and BW compared with placebo (p < 0.001), but not systolic BP. Adverse events were reported in 48.0%, 54.9%, and 47.0% of patients in the ertugliflozin 5 mg and 15 mg, and placebo groups. The incidences of symptomatic hypoglycemia were 11.0% (5 mg), 12.4% (15 mg), and 7.7% (placebo), and of severe hypoglycemia 2.0% (5 mg), 1.8% (15 mg), and 0.9% (placebo). Conclusions: In patients with T2DM and ASCVD, ertugliflozin added to metformin and SU improved glycemic control, reduced BW, and was generally well tolerated. Trial Registration: VERTIS CV ClinicalTrials.gov identifier, NCT01986881.
KW - Ertugliflozin
KW - Glycemic control
KW - HbA1c
KW - Metformin
KW - SGLT2 inhibitor
KW - Sulfonylurea
KW - Type 2 diabetes mellitus
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U2 - 10.1007/s13300-021-01033-x
DO - 10.1007/s13300-021-01033-x
M3 - Article
AN - SCOPUS:85102531206
SN - 1869-6953
JO - Diabetes Therapy
JF - Diabetes Therapy
ER -