Evidence map›Paper›PMID 30614616›Full record

Trial reportDiabetes, obesity & metabolism2019

Long-term efficacy and safety of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: 104-week VERTIS MET trial.

Silvina Gallo, Bernard Charbonnel, Allison Goldman, Harry Shi, Susan Huyck, Amanda Darekar, Brett Lauring, Steven G Terra

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02033889. Cited by 45 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 12 pooled it
6.2field-weighted citation impact, top 3% 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
PMID 28857451other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 12 syntheses or guidelines pooled it, 63 citations in OpenAlex.

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  8. 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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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

8 authors at 5 institutions in 4 countries.

Silvina GalloPfizer Deutschland GmbH, Berlin, Germany.
Bernard CharbonnelUniversity of Nantes, Nantes, France.
Allison GoldmanPfizer Inc., Collegeville, Pennsylvania.ORCID 0000-0002-5452-8375
Harry ShiPfizer Inc., New York, New York.
Susan HuyckMerck & Co., Inc., Kenilworth, New Jersey.
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) · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USNantes Université · FRPfizer (Germany) · DEPfizer (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate the long-term efficacy and safety of ertugliflozin in adults with type 2 diabetes mellitus inadequately controlled on metformin. MATERIALS AND

methodsA 104-week Phase III, randomized double-blind study with a 26-week placebo-controlled period (Phase A) and a 78-week period (Phase B) where blinded glimepiride was added to non-rescued placebo participants with fasting fingerstick glucose ≥6.1 mmol/L. Results through week 104 are reported.

resultsMean (standard error) change in HbA1c from baseline was -0.7% (0.07) and -1.0% (0.07) at week 52; -0.6% (0.08) and -0.9% (0.08) at week 104 for ertugliflozin 5 and 15 mg. At week 52, 34.8% and 36.6% participants had HbA1c <7.0%, and 24.6% and 33.7% at week 104, for ertugliflozin 5 and 15 mg. Ertugliflozin reduced fasting plasma glucose (FPG), body weight and systolic blood pressure (SBP) from baseline through week 104. The incidence of female genital mycotic infections (GMIs) was higher with ertugliflozin, and symptomatic hypoglycaemia was lower for ertugliflozin versus placebo/glimepiride. Minimal bone mineral density (BMD) changes were observed, similar to placebo/glimepiride, except at total hip where reduction in BMD was greater with ertugliflozin 15 mg versus placebo/glimepiride: difference in least squares means (95% CI) -0.50% (-0.95, -0.04) at week 52 and -0.84% (-1.44, -0.24) at week 104.

conclusionsErtugliflozin maintained improvements from baseline in HbA1c, FPG, body weight and SBP through week 104. Ertugliflozin was well tolerated, with non-clinically relevant changes in BMD. Compared with placebo/glimepiride, ertugliflozin increased female GMIs, but reduced the incidence of symptomatic hypoglycaemia. ClinicalTrials.gov Identifier: NCT02033889.

Indexed as

AgedBlood GlucoseBone DensityBridged Bicyclo Compounds, HeterocyclicDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsMaleMetforminMiddle AgedMycosesReproductive Tract InfectionsBlood GlucoseBridged Bicyclo Compounds, HeterocyclicertugliflozinglimepirideGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsMetforminSulfonylurea Compoundsbone mineral densitydurabilityertugliflozintype 2 diabetes mellitus

Identifiers

PMID30614616
PMCPMC6593724
OpenAlexW2908815907

What OpenQuestion holds

Texttitle and abstract
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.