PMID- 29282633
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231105
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 9
IP  - 1
DP  - 2018 Feb
TI  - Ertugliflozin Compared with Glimepiride in Patients with Type 2 Diabetes Mellitus 
      Inadequately Controlled on Metformin: The VERTIS SU Randomized Study.
PG  - 193-207
LID - 10.1007/s13300-017-0354-4 [doi]
AB  - INTRODUCTION: This study assessed the safety and efficacy of ertugliflozin (an 
      oral sodium-glucose cotransporter 2 inhibitor) vs. glimepiride in patients with 
      type 2 diabetes mellitus (T2DM) inadequately controlled on metformin. METHODS: 
      This phase III, double-blind, non-inferiority study (NCT01999218) randomized 
      patients with HbA1c >/= 7.0% and </= 9.0% on stable metformin >/= 1500 mg/day 1:1:1 to 
      ertugliflozin 15 or 5 mg once-daily (QD), or glimepiride (titrated from 1 mg QD). 
      The primary hypothesis was that ertugliflozin 15 mg was non-inferior to 
      glimepiride on HbA1c (non-inferiority criterion: upper bound of the 95% 
      confidence interval [CI] about the treatment difference < 0.3%). RESULTS: Mean 
      baseline HbA1c of randomized patients (N = 1326) was 7.8%. Mean and median doses 
      of glimepiride were 3.0 mg/day throughout the study. At week 52, the least 
      squares mean change (95% CI) from baseline in HbA1c was - 0.6% (- 0.7, - 0.5), 
      - 0.6% (- 0.6, - 0.5), and - 0.7% (- 0.8, - 0.7) in the ertugliflozin 15 mg, 
      ertugliflozin 5 mg, and glimepiride groups, respectively. The between-group 
      difference for ertugliflozin 15 mg and glimepiride of 0.1% (- 0.0, 0.2) met the 
      pre-specified non-inferiority criterion. Relative to glimepiride, greater body 
      weight and systolic blood pressure (SBP) reductions were observed with 
      ertugliflozin. The overall incidence of adverse events (AEs) was similar across 
      groups. The incidence of symptomatic hypoglycemia and genital mycotic infection 
      (GMI) were, respectively, lower and higher with ertugliflozin relative to 
      glimepiride. The incidences of urinary tract infection and hypovolemia AEs were 
      not meaningfully different among the groups. CONCLUSIONS: Ertugliflozin 15 mg was 
      non-inferior to glimepiride in reducing HbA1c when added to metformin in patients 
      with T2DM. Ertugliflozin had an acceptable safety profile and resulted in less 
      hypoglycemia and more GMIs than glimepiride. CLINICAL TRIAL REGISTRATION: 
      Clinicaltrials.gov NCT01999218.
FAU - Hollander, Priscilla
AU  - Hollander P
AD  - Baylor Endocrine Center, Dallas, TX, USA.
FAU - Liu, Jie
AU  - Liu J
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Hill, Julie
AU  - Hill J
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Johnson, Jeremy
AU  - Johnson J
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Jiang, Zhi Wei
AU  - Jiang ZW
AD  - MSD R&D (China) Co., Ltd, Beijing, China.
FAU - Golm, Gregory
AU  - Golm G
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Huyck, Susan
AU  - Huyck S
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Terra, Steven G
AU  - Terra SG
AD  - Pfizer Inc., Andover, MA, USA.
FAU - Mancuso, James P
AU  - Mancuso JP
AD  - Pfizer Inc., Groton, CT, USA.
FAU - Engel, Samuel S
AU  - Engel SS
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Lauring, Brett
AU  - Lauring B
AUID- ORCID: 0000-0002-9680-7452
AD  - Merck & Co., Inc., Kenilworth, NJ, USA. brett_lauring@merck.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT01999218
PT  - Journal Article
DEP - 20171227
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC5801240
OTO - NOTNLM
OT  - Ertugliflozin
OT  - Glycemic control
OT  - Sodium-glucose cotransporter 2 inhibitor
OT  - Sulfonylurea
OT  - Type 2 diabetes mellitus
EDAT- 2017/12/29 06:00
MHDA- 2017/12/29 06:01
PMCR- 2017/12/27
CRDT- 2017/12/29 06:00
PHST- 2017/11/16 00:00 [received]
PHST- 2017/12/29 06:00 [pubmed]
PHST- 2017/12/29 06:01 [medline]
PHST- 2017/12/29 06:00 [entrez]
PHST- 2017/12/27 00:00 [pmc-release]
AID - 10.1007/s13300-017-0354-4 [pii]
AID - 354 [pii]
AID - 10.1007/s13300-017-0354-4 [doi]
PST - ppublish
SO  - Diabetes Ther. 2018 Feb;9(1):193-207. doi: 10.1007/s13300-017-0354-4. Epub 2017 
      Dec 27.