PMID- 29313282
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 9
IP  - 1
DP  - 2018 Feb
TI  - Ertugliflozin and Sitagliptin Co-initiation in Patients with Type 2 Diabetes: The 
      VERTIS SITA Randomized Study.
PG  - 253-268
LID - 10.1007/s13300-017-0358-0 [doi]
AB  - INTRODUCTION: Ertugliflozin is an oral sodium-glucose cotransporter 2 inhibitor 
      that is being developed to treat type 2 diabetes mellitus (T2DM). This study 
      assessed the efficacy and safety of co-initiation of ertugliflozin and 
      sitagliptin compared with placebo in patients with T2DM inadequately controlled 
      on diet and exercise. METHODS: In this phase III, randomized, double-blind, 
      multicenter, placebo-controlled 26-week study (NCT02226003), patients with T2DM 
      and glycated hemoglobin (HbA1c) 8.0-10.5% on diet/exercise were randomized 1:1:1 
      to ertugliflozin 5 mg once daily (QD) and sitagliptin 100 mg QD (E5/S100), 
      ertugliflozin 15 mg QD and sitagliptin 100 mg QD (E15/S100), or placebo. The 
      primary efficacy endpoint was the change from baseline in HbA1c at week 26. 
      RESULTS: The mean baseline HbA1c of the randomized patients (n = 291) was 8.9%. 
      At week 26, both ertugliflozin/sitagliptin treatments provided significant 
      reductions from baseline in HbA1c compared with placebo [least squares mean HbA1c 
      change (95% confidence intervals) from baseline was - 0.4% (- 0.7, - 0.2), - 1.6% 
      (- 1.8, - 1.4), and - 1.7% (- 1.9, - 1.5) for placebo, E5/S100, and E15/S100, 
      respectively]. At week 26, 8.3%, 35.7%, and 31.3% of patients receiving placebo, 
      E5/S100, and E15/S100, respectively, had HbA1c < 7.0%. Significant reductions in 
      fasting plasma glucose, 2-h post-prandial glucose, body weight, and systolic 
      blood pressure were observed with both ertugliflozin/sitagliptin groups compared 
      with placebo. The incidence of adverse events (AEs) was similar across the 
      groups. The incidences of the pre-specified AEs of urinary tract infection, 
      genital mycotic infection, symptomatic hypoglycemia, and hypovolemia were low and 
      not meaningfully different across groups. CONCLUSION: Co-initiation of 
      ertugliflozin with sitagliptin in patients with T2DM inadequately controlled on 
      diet and exercise provided a clinically meaningful improvement in glycemic 
      control over 26 weeks. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov 
      NCT02226003.
FAU - Miller, Sam
AU  - Miller S
AD  - SAM Clinical Research Center, San Antonio, TX, USA.
FAU - Krumins, Tania
AU  - Krumins T
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Zhou, Haojin
AU  - Zhou H
AD  - MSD R&D (China) Co., Ltd., Beijing, China.
FAU - Huyck, Susan
AU  - Huyck S
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Johnson, Jeremy
AU  - Johnson J
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Golm, Gregory
AU  - Golm G
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/NCT02226003
PT  - Journal Article
DEP - 20180108
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC5801244
OTO - NOTNLM
OT  - Ertugliflozin
OT  - Glycemic control
OT  - SGLT2 inhibitor
OT  - Sitagliptin
OT  - Type 2 diabetes mellitus
EDAT- 2018/01/10 06:00
MHDA- 2018/01/10 06:01
PMCR- 2018/01/08
CRDT- 2018/01/10 06:00
PHST- 2017/11/16 00:00 [received]
PHST- 2018/01/10 06:00 [pubmed]
PHST- 2018/01/10 06:01 [medline]
PHST- 2018/01/10 06:00 [entrez]
PHST- 2018/01/08 00:00 [pmc-release]
AID - 10.1007/s13300-017-0358-0 [pii]
AID - 358 [pii]
AID - 10.1007/s13300-017-0358-0 [doi]
PST - ppublish
SO  - Diabetes Ther. 2018 Feb;9(1):253-268. doi: 10.1007/s13300-017-0358-0. Epub 2018 
      Jan 8.