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)

Julio Rosenstock, Juan Frias, D. Páll, Bernard Charbonnel, Raluca Pascu, Didier Saur, Amanda Darekar, Susan Huyck, Harry Shi, Brett Lauring, Steven G. Terra

Research output: Contribution to journalArticle

43 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)520-529
Number of pages10
JournalDiabetes, Obesity and Metabolism
Volume20
Issue number3
DOIs
Publication statusPublished - Mar 1 2018

Fingerprint

Metformin
Bone Density
Type 2 Diabetes Mellitus
Body Weight
Blood Pressure
Glucose
Placebos
Incidence
Fasting
5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-hydroxymethyl-6,8-dioxabicyclo(3.2.1)octane-2,3,4-triol
Hypovolemia
Anniversaries and Special Events
Infection
Least-Squares Analysis
Hypoglycemia
Urinary Tract Infections
Multicenter Studies
Safety

Keywords

  • bone mineral density
  • ertugliflozin
  • SGLT2 inhibitor
  • type 2 diabetes mellitus

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

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). / Rosenstock, Julio; Frias, Juan; Páll, D.; Charbonnel, Bernard; Pascu, Raluca; Saur, Didier; Darekar, Amanda; Huyck, Susan; Shi, Harry; Lauring, Brett; Terra, Steven G.

In: Diabetes, Obesity and Metabolism, Vol. 20, No. 3, 01.03.2018, p. 520-529.

Research output: Contribution to journalArticle

Rosenstock, Julio ; Frias, Juan ; Páll, D. ; Charbonnel, Bernard ; Pascu, Raluca ; Saur, Didier ; Darekar, Amanda ; Huyck, Susan ; Shi, Harry ; Lauring, Brett ; Terra, Steven G. / 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). In: Diabetes, Obesity and Metabolism. 2018 ; Vol. 20, No. 3. pp. 520-529.
@article{50f166fa993b44f499825249f4f8a3c9,
title = "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)",
abstract = "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.",
keywords = "bone mineral density, ertugliflozin, SGLT2 inhibitor, type 2 diabetes mellitus",
author = "Julio Rosenstock and Juan Frias and D. P{\'a}ll and Bernard Charbonnel and Raluca Pascu and Didier Saur and Amanda Darekar and Susan Huyck and Harry Shi and Brett Lauring and Terra, {Steven G.}",
year = "2018",
month = "3",
day = "1",
doi = "10.1111/dom.13103",
language = "English",
volume = "20",
pages = "520--529",
journal = "Diabetes, Obesity and Metabolism",
issn = "1462-8902",
publisher = "Wiley-Blackwell",
number = "3",

}

TY - JOUR

T1 - 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)

AU - Rosenstock, Julio

AU - Frias, Juan

AU - Páll, D.

AU - Charbonnel, Bernard

AU - Pascu, Raluca

AU - Saur, Didier

AU - Darekar, Amanda

AU - Huyck, Susan

AU - Shi, Harry

AU - Lauring, Brett

AU - Terra, Steven G.

PY - 2018/3/1

Y1 - 2018/3/1

N2 - 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.

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.

KW - bone mineral density

KW - ertugliflozin

KW - SGLT2 inhibitor

KW - type 2 diabetes mellitus

UR - http://www.scopus.com/inward/record.url?scp=85030632365&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85030632365&partnerID=8YFLogxK

U2 - 10.1111/dom.13103

DO - 10.1111/dom.13103

M3 - Article

C2 - 28857451

AN - SCOPUS:85030632365

VL - 20

SP - 520

EP - 529

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

SN - 1462-8902

IS - 3

ER -