title: Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone.
abstract: To conduct a phase III study to evaluate the efficacy and safety of ertugliflozin monotherapy in people with type 2 diabetes.
  
  
  
  This was a 52-week, double-blind, multicentre, randomized, parallel-group study with a 26-week, placebo-controlled treatment period (phase A), followed by a 26-week active-controlled treatment period (phase B) in 461 men and women, aged ≥18 years with inadequate glycaemic control (glycated haemoglobin [HbA1c] concentration 7.0% to 10.5% [53-91 mmol/mol], inclusive) despite diet and exercise. Results from phase A are reported in the present paper. The primary endpoint was the change in HbA1c from baseline to week 26.
  
  
  
  At week 26, the placebo-adjusted least squares mean HbA1c changes from baseline were -0.99% and -1.16% for the ertugliflozin 5 and 15 mg doses, respectively ( P  < .001 for both doses). The odds of having HbA1c <7.0% (53 mmol/mol) were significantly greater in the ertugliflozin 5 and 15 mg groups compared with the placebo group. Both doses of ertugliflozin significantly lowered fasting plasma glucose and 2-hour postprandial glucose levels and body weight. The placebo-adjusted differences in changes from baseline in systolic blood pressure were not statistically significant. A higher incidence of genital mycotic infections occurred in men and women treated with ertugliflozin compared with placebo. There was no significant difference between treatments in the proportion of participants with symptomatic hypoglycaemia or adverse events associated with urinary tract infection or hypovolaemia.
  
  
  
  Ertugliflozin 5 and 15 mg treatment for 26 weeks provides effective glycaemic control, reduces body weight and is generally well tolerated, when used as monotherapy.
authors.affiliation: Pfizer, Andover, Massachusetts.
authors.forename: Steven G
authors.identifier: 0000-0002-5815-6193
authors.initials: SG
authors.lastname: Terra
authors.affiliation: Pfizer, Collegeville, Pennsylvania.
authors.forename: Kristen
authors.initials: K
authors.lastname: Focht
authors.affiliation: Diabetes Research Centre, University of Leicester, Leicester, UK.
authors.forename: Melanie
authors.identifier: 0000-0002-9987-9371
authors.initials: M
authors.lastname: Davies
authors.affiliation: National Research Institute, Los Angeles, California.
authors.forename: Juan
authors.initials: J
authors.lastname: Frias
authors.affiliation: University of Pavia and IRCCS Policlinico San Matteo Foundation, Pavia, Italy.
authors.forename: Giuseppe
authors.identifier: 0000-0003-3573-4760
authors.initials: G
authors.lastname: Derosa
authors.affiliation: Pfizer Ltd, Tadworth, UK.
authors.forename: Amanda
authors.initials: A
authors.lastname: Darekar
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey.
authors.forename: Gregory
authors.initials: G
authors.lastname: Golm
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Johnson
authors.affiliation: Pfizer, Paris, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Saur
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey.
authors.forename: Brett
authors.initials: B
authors.lastname: Lauring
authors.affiliation: University of Tennessee Health Sciences Center, Memphis, Tennessee.
authors.forename: Sam
authors.initials: S
authors.lastname: Dagogo-Jack
mesh_terms: D019440:Anti-Obesity Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy / Q000009:adverse effects; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000276:immunology / Q000378:metabolism / Q000628:therapy; D003927:Diet, Diabetic; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D015444:Exercise; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007003:Hypoglycemia / Q000139:chemically induced / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018928:Immunity, Mucosal / Q000187:drug effects; D015994:Incidence; D008297:Male; D049990:Membrane Transport Modulators / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009181:Mycoses / Q000453:epidemiology / Q000276:immunology / Q000382:microbiology; D050177:Overweight / Q000188:drug therapy / Q000276:immunology / Q000378:metabolism / Q000628:therapy; D060737:Reproductive Tract Infections / Q000453:epidemiology / Q000276:immunology / Q000382:microbiology; D051297:Sodium-Glucose Transporter 2 / Q000378:metabolism; D000077203:Sodium-Glucose Transporter 2 Inhibitors
chemical_list: D019440:Anti-Obesity Agents; D019086:Bridged Bicyclo Compounds, Heterocyclic; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D049990:Membrane Transport Modulators; D051297:Sodium-Glucose Transporter 2; D000077203:Sodium-Glucose Transporter 2 Inhibitors; C517652:hemoglobin A1c protein, human; C570288:ertugliflozin
keywords: 
  SGLT2
  ; ertugliflozin; monotherapy; type 2 diabetes mellitus