Evidence map›Paper›PMID 29419917›Full record

Trial reportDiabetes, obesity & metabolism2018

Long-term efficacy and safety of ertugliflozin monotherapy in patients with inadequately controlled T2DM despite diet and exercise: VERTIS MONO extension study.

Ronnie Aronson, Juan Frias, Allison Goldman, Amanda Darekar, Brett Lauring, Steven G Terra

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC 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. It reports registered trial NCT01958671. Cited by 46 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 9 pooled it
9.3field-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.

NCT01958671 phase3completed

A Phase 3, Randomized, Double-blind, Placebo-controlled, 26-week Multicenter Study With a 26-Week Extension to Evaluate the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise

Ran2013Enrolled461Registered outcomes12Posted comparisons18ConditionsType 2 Diabetes MellitusArmsErtugliflozin 10 mg, Ertugliflozin 5 mg, Glimepiride, Metformin, Placebo to Ertugliflozin
PMID 28116776other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 9 syntheses or guidelines pooled it, 96 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 3 countries.

Ronnie AronsonLMC Diabetes and Endocrinology, East York, Canada.ORCID 0000-0002-8976-2321
Juan FriasNational Research Institute, Los Angeles, California.ORCID 0000-0001-9486-1255
Allison GoldmanPfizer, Inc., Collegeville, Pennsylvania.ORCID 0000-0002-5452-8375
Amanda DarekarPfizer Ltd., Tadworth, UK.
Brett LauringMerck & Co., Inc., Kenilworth, New Jersey.ORCID 0000-0002-9680-7452
Steven G TerraPfizer, Inc., Andover, Massachusetts.ORCID 0000-0002-5815-6193
Pfizer (United States) · USLMC Diabetes & Endocrinology (Canada) · CAMerck & Co., Inc., Rahway, NJ, USA (United States) · USNational Research Institute · USPfizer (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThis phase III, multicentre, randomized study (ClinicalTrials.gov; NCT01958671) evaluated the efficacy and safety of ertugliflozin monotherapy in adults with inadequately controlled type 2 diabetes (glycated haemoglobin [HbA1c], 7.0% to 10.5% [53-91 mmol/mol]) despite diet and exercise. MATERIALS AND

methodsThe 52-week study comprised a 26-week, double-blind, placebo-controlled period (Phase A) during which 461 participants received placebo, ertugliflozin 5 mg/d or ertugliflozin 15 mg/d. This was followed by a 26-week active-controlled period (Phase B) during which participants in the placebo group who had not received glycaemic rescue therapy had blinded metformin added. Results to Week 52 are reported. Because of the use of metformin in Phase B, no statistical comparisons of efficacy were made between the ertugliflozin and placebo/metformin groups at Week 52.

resultsThe mean (standard error) change from baseline to Week 52 in HbA1c was -0.9% (0.1) and -1.0% (0.1) in the ertugliflozin 5 and 15 mg groups, respectively. The proportions of participants with HbA1c <7.0% at Week 52 were 25.6% and 28.5%, respectively. Ertugliflozin reduced fasting plasma glucose, body weight and systolic blood pressure (SBP). The incidence of genital mycotic infections (GMIs) in females was significantly higher in both ertugliflozin groups (5 mg, 26.9%; 15 mg, 29.0%) vs the placebo/metformin group (9.9%), and in males was significantly higher in the 15 mg group (7.8%) vs the placebo/metformin group (1.2%). Ertugliflozin was not associated with increased incidence of urinary tract infections, symptomatic hypoglycaemia or hypovolaemia adverse events compared with placebo/metformin.

conclusionsErtugliflozin treatment over 52 weeks improved glycaemic control and reduced body weight and SBP, but increased GMIs.

Indexed as

AdolescentAdultAgedBlood GlucoseBridged Bicyclo Compounds, HeterocyclicDiabetes Mellitus, Type 2Double-Blind MethodExercise TherapyFemaleGlycated HemoglobinHumansHypoglycemic AgentsMaleMiddle AgedSodium-Glucose Transporter 2 InhibitorsTreatment OutcomeBlood GlucoseBridged Bicyclo Compounds, HeterocyclicertugliflozinGlycated HemoglobinHypoglycemic AgentsSodium-Glucose Transporter 2 InhibitorsertugliflozinmonotherapySGLT2 inhibitortype 2 diabetes mellitus

Identifiers

PMID29419917
PMCPMC5969239
OpenAlexW2790160447

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.