PMID- 36763328
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230224
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 14
IP  - 2
DP  - 2023 Feb
TI  - Efficacy and Safety of Ertugliflozin Added to Metformin: A Pooled Population from 
      Asia with Type 2 Diabetes and Overweight or Obesity.
PG  - 319-334
LID - 10.1007/s13300-022-01345-6 [doi]
AB  - INTRODUCTION: The efficacy and safety of ertugliflozin have not been well 
      characterized in Asian populations with type 2 diabetes (T2D) and overweight or 
      obesity as defined by the Chinese Diabetes Society [body mass index 
      (BMI) >/= 24 kg/m(2)]. METHODS: These post hoc analyses of pooled data from two 
      randomized, double-blind, 26-week studies assessed the efficacy and safety of 
      ertugliflozin (5 mg or 15 mg) compared with placebo in participants from Asia 
      with T2D and baseline BMI >/= 24 kg/m(2), with inadequate glycemic control on 
      metformin. Longitudinal analyses were used to calculate least squares (LS) mean 
      [95% confidence interval (CI)] change from baseline in glycemic indices and body 
      weight. The proportions of participants achieving efficacy targets and 
      experiencing adverse events (AEs) were assessed. RESULTS: The 445 participants 
      had a mean age of 55.5 years, T2D duration 6.6 years, glycated hemoglobin (HbA1c) 
      8.1%, and BMI 27.6 kg/m(2). At week 26, placebo-adjusted LS mean (95% CI) changes 
      from baseline for ertugliflozin 5 mg and 15 mg, respectively, were - 0.78% 
      (- 0.95% to - 0.61%) and - 0.80% (- 0.98% to - 0.63%) for HbA1c, and - 1.74 kg 
      (- 2.29 kg to - 1.19 kg) and - 2.04 kg (- 2.60 kg to - 1.48 kg) for body weight. 
      A greater proportion of participants receiving ertugliflozin 5 mg and 15 mg 
      versus placebo, respectively, achieved HbA1c < 7.0% (42.1% and 46.3% vs. 13.9%), 
      body weight reduction >/= 5% (35.5% and 38.3% vs. 11.1%), and systolic blood 
      pressure < 130 mmHg (42.4% and 34.5% vs. 21.7%). The proportion of participants 
      with AEs was 52.6% (ertugliflozin 5 mg), 52.3% (ertugliflozin 15 mg), and 55.6% 
      (placebo). CONCLUSIONS: In participants from Asia with T2D inadequately 
      controlled by metformin monotherapy, and BMI >/=24 kg/m(2), ertugliflozin (5 mg or 
      15 mg) resulted in greater glycemic and body weight reductions compared with 
      placebo and was generally well tolerated. TRIAL REGISTRATION: Clinicaltrials.gov 
      identifiers NCT02033889, NCT02630706.
CI  - (c) 2023. Pfizer Inc., Merck & Co., Inc., Rahway, NJ, USA and its affiliates, and 
      Linong Ji.
FAU - Ji, Linong
AU  - Ji L
AD  - Endocrinology and Metabolism, Peking University People's Hospital, Beijing, 
      China.
FAU - Liu, Jie
AU  - Liu J
AD  - Global Clinical Development, MRL, Merck & Co., Inc., Rahway, NJ, USA.
FAU - Xu, Zhi Jin
AU  - Xu ZJ
AUID- ORCID: 0000-0002-5916-1605
AD  - Biostatistics, Merck & Co., Inc., Rahway, NJ, USA.
FAU - Wei, Zhiqi
AU  - Wei Z
AD  - Global Medical Affairs, MRL, MSD China, Shanghai, China.
FAU - Zhang, Ruya
AU  - Zhang R
AD  - Global Medical Affairs, MRL, MSD China, Shanghai, China.
FAU - Malkani, Seema
AU  - Malkani S
AD  - Global Medical and Scientific Affairs, MRL, Merck & Co., Inc., Rahway, NJ, USA.
FAU - Cater, Nilo B
AU  - Cater NB
AUID- ORCID: 0000-0001-5868-8643
AD  - Global Medical Affairs, Pfizer Inc., New York, NY, USA. Nilo.Cater@pfizer.com.
FAU - Frederich, Robert
AU  - Frederich R
AUID- ORCID: 0000-0002-5175-3112
AD  - Clinical Development and Operations, Pfizer Inc., Groton, CT, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02033889
SI  - ClinicalTrials.gov/NCT02630706
PT  - Journal Article
DEP - 20230203
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC9944172
OTO - NOTNLM
OT  - Asia
OT  - Ertugliflozin
OT  - Obese
OT  - Overweight
OT  - Type 2 diabetes
EDAT- 2023/02/11 06:00
MHDA- 2023/02/11 06:01
PMCR- 2023/02/03
CRDT- 2023/02/10 11:23
PHST- 2022/10/13 00:00 [received]
PHST- 2022/11/11 00:00 [accepted]
PHST- 2023/02/11 06:00 [pubmed]
PHST- 2023/02/11 06:01 [medline]
PHST- 2023/02/10 11:23 [entrez]
PHST- 2023/02/03 00:00 [pmc-release]
AID - 10.1007/s13300-022-01345-6 [pii]
AID - 1345 [pii]
AID - 10.1007/s13300-022-01345-6 [doi]
PST - ppublish
SO  - Diabetes Ther. 2023 Feb;14(2):319-334. doi: 10.1007/s13300-022-01345-6. Epub 2023 
      Feb 3.