PMID- 32324065
OWN - NLM
STAT- MEDLINE
DCOM- 20210510
LR  - 20221207
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 36
IP  - 7
DP  - 2020 Jul
TI  - Efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 
      diabetes mellitus.
PG  - 1097-1106
LID - 10.1080/03007995.2020.1760227 [doi]
AB  - Objective: To assess the efficacy and safety of ertugliflozin in Hispanic/Latino 
      patients with type 2 diabetes (T2DM).Methods: Analysis of data from 
      Hispanic/Latino patients who participated in randomized, double-blind phase III 
      studies. Ertugliflozin efficacy was evaluated when initiated as a single agent 
      (as monotherapy or add-on therapy) and when initiated in combination with 
      sitagliptin. Least-squares mean change from baseline was calculated for glycated 
      hemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP). Safety 
      evaluation included overall and prespecified adverse events (AEs).Results: 
      Analyses included 1178 Hispanic/Latino patients. In a pooled analysis of three 
      placebo-controlled studies where ertugliflozin was initiated as a single agent, 
      the placebo-corrected change from baseline in HbA1c at week 26 for ertugliflozin 
      5 and 15 mg was -0.8 and -1.0%, respectively. In an active-comparator study, when 
      initiated as a single agent, the change from baseline in HbA1c at week 52 was 
      -0.5, -0.7, and -0.5% for ertugliflozin 5 mg, ertugliflozin 15 mg, and 
      glimepiride, respectively. In a placebo-controlled study, when initiated in 
      combination with sitagliptin, the placebo-corrected change from baseline in HbA1c 
      at week 26 for ertugliflozin 5 mg/sitagliptin and ertugliflozin 15 mg/sitagliptin 
      was -1.3 and -1.6%, respectively. In an active-comparator study, when initiated 
      in combination with sitagliptin, the change from baseline in HbA1c at week 26 was 
      -1.4, -1.6, and -0.9 for ertugliflozin 5 mg/sitagliptin, ertugliflozin 
      15 mg/sitagliptin, and sitagliptin alone, respectively. Reductions in BW and SBP 
      were observed with ertugliflozin as a single agent or combined with sitagliptin. 
      The incidences of overall and prespecified AEs in Hispanic/Latino patients were 
      generally consistent with the known safety profile of ertugliflozin.Conclusion: 
      Ertugliflozin, administered as a single agent or as a combination with 
      sitagliptin, improved HbA1c, BW, and SBP. Ertugliflozin was generally 
      well-tolerated in Hispanic/Latino patients with T2DM. Clinicaltrials.gov 
      identifiers: NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, 
      NCT02033889, and NCT02226003.
FAU - Liu, Jie
AU  - Liu J
AD  - Merck & Co., Inc, Kenilworth, NJ, USA.
FAU - Tarasenko, Lisa
AU  - Tarasenko L
AD  - Pfizer Inc., New York, NY, USA.
FAU - Pong, Annpey
AU  - Pong A
AD  - Merck & Co., Inc, Kenilworth, NJ, USA.
FAU - Huyck, Susan
AU  - Huyck S
AD  - Merck & Co., Inc, Kenilworth, NJ, USA.
FAU - Patel, Shrita
AU  - Patel S
AD  - Merck & Co., Inc, Kenilworth, NJ, USA.
FAU - Hickman, Anne
AU  - Hickman A
AD  - Pfizer Inc., Groton, CT, USA.
FAU - Mancuso, James P
AU  - Mancuso JP
AD  - Pfizer Inc., Groton, CT, USA.
FAU - Ellison, Misoo C
AU  - Ellison MC
AD  - Merck & Co., Inc, Kenilworth, NJ, USA.
FAU - Gantz, Ira
AU  - Gantz I
AD  - Merck & Co., Inc, Kenilworth, NJ, USA.
FAU - Terra, Steven G
AU  - Terra SG
AUID- ORCID: 0000-0002-5815-6193
AD  - Pfizer Inc., Andover, MA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01986855
SI  - ClinicalTrials.gov/NCT02033889
SI  - ClinicalTrials.gov/NCT01999218
SI  - ClinicalTrials.gov/NCT02226003
SI  - ClinicalTrials.gov/NCT01958671
SI  - ClinicalTrials.gov/NCT02036515
SI  - ClinicalTrials.gov/NCT02099110
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200513
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Bridged Bicyclo Compounds, Heterocyclic)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 6C282481IP (ertugliflozin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Bridged Bicyclo Compounds, Heterocyclic/adverse effects/*therapeutic use
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Hispanic or Latino
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Sodium-Glucose Transporter 2 Inhibitors/*therapeutic use
OTO - NOTNLM
OT  - HbA1c
OT  - Hispanic
OT  - Latino
OT  - SGLT2 inhibitor
OT  - ethnicity
OT  - type 2 diabetes
EDAT- 2020/04/24 06:00
MHDA- 2021/05/11 06:00
CRDT- 2020/04/24 06:00
PHST- 2020/04/24 06:00 [pubmed]
PHST- 2021/05/11 06:00 [medline]
PHST- 2020/04/24 06:00 [entrez]
AID - 10.1080/03007995.2020.1760227 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2020 Jul;36(7):1097-1106. doi: 10.1080/03007995.2020.1760227. 
      Epub 2020 May 13.