Evidence map›Paper›PMID 28857451›Full record

Trial reportDiabetes, obesity & metabolism2018

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, Dénes Páll, Bernard Charbonnel, Raluca Pascu, Didier Saur, Amanda Darekar, Susan Huyck, Harry Shi, Brett Lauring and 1 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It reports registered trial NCT02033889. Cited by 98 papers, 27 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
98citing papers in PubMed, 27 pooled it
14.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02033889 phase3completed

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study With a 78-Week Extension To Evaluate The Efficacy And Safety Of Ertugliflozin In Subjects With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monotherapy.

Ran2013Enrolled621Registered outcomes49Posted comparisons42ConditionsType 2 Diabetes MellitusArmsBasal Insulin, Ertugliflozin 15 mg, Ertugliflozin 5 mg, Glimepiride, Metformin
Open the trial in the graph
3 · Its place in the literature

Who cites it

98 citing papers in PubMed, 27 syntheses or guidelines pooled it, 188 citations in OpenAlex.

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  12. Effect of SGLT2 inhibitors on fractures, BMD, and bone metabolism markers in patients with type 2 diabetes mellitus: a systematic review and meta-analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2023
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38 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 4 countries.

Julio RosenstockDallas Diabetes Research Center at Medical City, Dallas, Texas.
Juan FriasNational Research Institute, Los Angeles, California.
Dénes PállUniversity of Debrecen, Debrecen, Hungary.
Bernard CharbonnelUniversity of Nantes, Nantes, France.
Raluca PascuPfizer, Paris, France.
Didier SaurPfizer, Paris, France.
Amanda DarekarPfizer, Tadworth, UK.
Susan HuyckMerck & Co., Inc, Kenilworth, New Jersey.
Harry ShiPfizer Inc, New York, New York.
Brett LauringMerck & Co., Inc, Kenilworth, New Jersey.ORCID 0000-0002-9680-7452
Steven G TerraPfizer Inc, Andover, Massachusetts.ORCID 0000-0002-5815-6193
Merck & Co., Inc., Rahway, NJ, USA (United States) · USPfizer (France) · FRPfizer (United States) · USDallas Diabetes Research Center · USNantes Université · FRNational Research Institute · USPfizer (United Kingdom) · GBUniversity of Debrecen · HU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimWe 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).

methodsThis 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.

resultsAt 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.

conclusionsErtugliflozin 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.

Indexed as

AdultAgedBlood GlucoseBlood PressureBone DensityBridged Bicyclo Compounds, HeterocyclicDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlycated HemoglobinHumansHypoglycemic AgentsMaleMetforminMiddle AgedSodium-Glucose Transporter 2 InhibitorsBlood GlucoseBridged Bicyclo Compounds, HeterocyclicertugliflozinGlycated HemoglobinHypoglycemic AgentsMetforminSodium-Glucose Transporter 2 Inhibitorsbone mineral densityertugliflozinSGLT2 inhibitortype 2 diabetes mellitus

Identifiers

PMID28857451
OpenAlexW2752384709

What Socratic holds

Texttitle and abstract
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.