PMID- 28857451
OWN - NLM
STAT- MEDLINE
DCOM- 20181211
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 20
IP  - 3
DP  - 2018 Mar
TI  - Effect of ertugliflozin on glucose control, body weight, blood pressure and bone 
      density in type 2 diabetes mellitus inadequately controlled on metformin 
      monotherapy (VERTIS MET).
PG  - 520-529
LID - 10.1111/dom.13103 [doi]
AB  - AIM: We evaluated the efficacy and safety of ertugliflozin, an SGLT2 inhibitor, 
      in type 2 diabetes mellitus (T2DM) inadequately controlled (HbA1c, 7.0%-10.5%) 
      with metformin monotherapy (>/=1500 mg/d for >/=8 weeks). METHODS: This was a 
      double-blind, 26-week, multicentre study with ongoing 78-week extension 
      (ClinicalTrials.gov identifier: NCT02033889). A total of 621 participants were 
      randomized 1:1:1 to placebo, or ertugliflozin 5 or 15 mg/d. The primary endpoint 
      was change from baseline at week 26 in HbA1c. Secondary efficacy endpoints were 
      change from baseline at week 26 in fasting plasma glucose (FPG), body weight, 
      systolic/diastolic blood pressure (SBP/DBP) and number of participants with HbA1c 
      <7.0% (53 mmol/mol). Pre-specified adverse events (AEs) of special interest and 
      percent change from baseline in bone mineral density (BMD) were also assessed at 
      week 26. RESULTS: At week 26, the placebo-adjusted least-squares mean change from 
      baseline HbA1c (8.1%) was -0.7% and -0.9% for ertugliflozin 5 and 15 mg, 
      respectively (both P < .001), to final means of 7.3% and 7.2%, respectively. The 
      odds of HbA1c <7.0% were significantly greater in both ertugliflozin groups vs 
      placebo. Ertugliflozin significantly reduced FPG, body weight, SBP and DBP vs 
      placebo. The incidence of genital mycotic infections was higher in the 
      ertugliflozin groups (female subjects: placebo, 0.9%; ertugliflozin 5 mg, 5.5%; 
      ertugliflozin 15 mg, 6.3% [P = .032]; male subjects: 0%; 3.1%; 3.2%, 
      respectively), as was the incidence of urinary tract infections and symptomatic 
      hypoglycaemia. The incidence of hypovolaemia AEs was similar across groups. 
      Ertugliflozin had no adverse impact on BMD at week 26. CONCLUSIONS: Ertugliflozin 
      added to metformin in patients with inadequately controlled T2DM improved 
      glycaemic control, reduced body weight and BP, but increased the incidence of 
      genital mycotic infections.
CI  - (c) 2017 John Wiley & Sons Ltd.
FAU - Rosenstock, Julio
AU  - Rosenstock J
AD  - Dallas Diabetes Research Center at Medical City, Dallas, Texas.
FAU - Frias, Juan
AU  - Frias J
AD  - National Research Institute, Los Angeles, California.
FAU - Pall, Denes
AU  - Pall D
AD  - University of Debrecen, Debrecen, Hungary.
FAU - Charbonnel, Bernard
AU  - Charbonnel B
AD  - University of Nantes, Nantes, France.
FAU - Pascu, Raluca
AU  - Pascu R
AD  - Pfizer, Paris, France.
FAU - Saur, Didier
AU  - Saur D
AD  - Pfizer, Paris, France.
FAU - Darekar, Amanda
AU  - Darekar A
AD  - Pfizer, Tadworth, UK.
FAU - Huyck, Susan
AU  - Huyck S
AD  - Merck & Co., Inc, Kenilworth, New Jersey.
FAU - Shi, Harry
AU  - Shi H
AD  - Pfizer Inc, New York, New York.
FAU - Lauring, Brett
AU  - Lauring B
AUID- ORCID: 0000-0002-9680-7452
AD  - Merck & Co., Inc, Kenilworth, New Jersey.
FAU - Terra, Steven G
AU  - Terra SG
AUID- ORCID: 0000-0002-5815-6193
AD  - Pfizer Inc, Andover, Massachusetts.
LA  - eng
SI  - ClinicalTrials.gov/NCT02033889
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20171002
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Bridged Bicyclo Compounds, Heterocyclic)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 6C282481IP (ertugliflozin)
RN  - 9100L32L2N (Metformin)
SB  - IM
EIN - Diabetes Obes Metab. 2018 Nov;20(11):2708. PMID: 30295414
MH  - Adult
MH  - Aged
MH  - Blood Glucose/drug effects/metabolism
MH  - Blood Pressure/drug effects
MH  - Bone Density/drug effects
MH  - Bridged Bicyclo Compounds, Heterocyclic/*administration & dosage
MH  - Diabetes Mellitus, Type 2/blood/physiopathology/*prevention & control
MH  - Double-Blind Method
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage
MH  - Male
MH  - Metformin/administration & dosage
MH  - Middle Aged
MH  - Sodium-Glucose Transporter 2 Inhibitors/*administration & dosage
MH  - Treatment Outcome
MH  - Weight Loss/drug effects
MH  - Young Adult
OTO - NOTNLM
OT  - SGLT2 inhibitor
OT  - bone mineral density
OT  - ertugliflozin
OT  - type 2 diabetes mellitus
EDAT- 2017/09/01 06:00
MHDA- 2018/12/12 06:00
CRDT- 2017/09/01 06:00
PHST- 2017/08/03 00:00 [received]
PHST- 2017/08/23 00:00 [revised]
PHST- 2017/08/24 00:00 [accepted]
PHST- 2017/09/01 06:00 [pubmed]
PHST- 2018/12/12 06:00 [medline]
PHST- 2017/09/01 06:00 [entrez]
AID - 10.1111/dom.13103 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2018 Mar;20(3):520-529. doi: 10.1111/dom.13103. Epub 2017 
      Oct 2.