Evidence map›Paper›PMID 29159457›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2018

Ertugliflozin in Patients with Stage 3 Chronic Kidney Disease and Type 2 Diabetes Mellitus: The VERTIS RENAL Randomized Study.

George Grunberger, Sarah Camp, Jeremy Johnson, Susan Huyck, Steven G Terra, James P Mancuso, Zhi Wei Jiang, Gregory Golm, Samuel S Engel, Brett Lauring

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01986855 (A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ertugliflozin), which is not on this map. Cited by 90 papers, 38 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 38 pooled it
9.9field-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.

NCT01986855 phase3completednot on this map

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Background Antihyperglycemic Therapy

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2013 to 2016Enrolled468ConditionsType 2 Diabetes MellitusArmsErtugliflozin 5 mg, Placebo 5 mg, Ertugliflozin 10 mg, Placebo 10 mg
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 38 syntheses or guidelines pooled it, 149 citations in OpenAlex.

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30 more citing papers are in PubMed but not listed here.

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

10 authors at 3 institutions in 1 country.

George GrunbergerGrunberger Diabetes Institute, Bloomfield Hills, MI, USA.
Sarah CampMerck & Co., Inc., Kenilworth, NJ, USA.
Jeremy JohnsonMerck & Co., Inc., Kenilworth, NJ, USA.
Susan HuyckMerck & Co., Inc., Kenilworth, NJ, USA.
Steven G TerraPfizer Inc., Andover, MA, USA.
James P MancusoPfizer Inc., Groton, CT, USA.
Zhi Wei JiangMSD China, Beijing, China.
Gregory GolmMerck & Co., Inc., Kenilworth, NJ, USA.
Samuel S EngelMerck & Co., Inc., Kenilworth, NJ, USA.
Brett LauringMerck & Co., Inc., Kenilworth, NJ, USA. brett_lauring@merck.com.ORCID http://orcid.org/0000-0002-9680-7452
Merck & Co., Inc., Rahway, NJ, USA (United States) · USPfizer (United States) · USGrunberger Diabetes Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionErtugliflozin is a sodium-glucose cotransporter 2 inhibitor in development for type 2 diabetes mellitus (T2DM). The safety and efficacy of ertugliflozin were evaluated over 52 weeks in patients with chronic kidney disease (CKD).

methodsIn this double-blind randomized study (NCT01986855), patients with glycated hemoglobin (A1C) 7.0-10.5% and stage 3 CKD [estimated glomerular filtration rate (eGFR) ≥ 30 to < 60 mL/min/1.73 m

results468 patients were randomized (baseline mean A1C 8.2%). At week 26, reductions from baseline in A1C were observed across groups in the overall cohort [least squares mean changes (95% confidence interval) - 0.3% (- 0.4, - 0.1), - 0.3% (- 0.4, - 0.1), and - 0.4% (- 0.6, - 0.3) for placebo and for ertugliflozin 5 mg and 15 mg, respectively]. Prohibited use of metformin was identified in ~ 17% of patients and impacted evaluation of the primary endpoint. Greater reductions from baseline in body weight, fasting plasma glucose, and systolic blood pressure were observed with ertugliflozin versus placebo at week 26 (stage 3A CKD cohort). The incidences of urinary tract infections, genital mycotic infections, and hypoglycemia adverse events were not meaningfully different between groups. The incidence of hypovolemia-related adverse events was higher with ertugliflozin relative to placebo.

conclusionAlthough surreptitious metformin use impacted the primary analysis, reductions in blood glucose and body weight were observed with ertugliflozin in patients with T2DM and stage 3 CKD; ertugliflozin had an acceptable safety profile.

fundingMerck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and Pfizer Inc.

trial registrationClinicaltrials.gov identifier NCT01986855.

Indexed as

Chronic kidney diseaseErtugliflozinGlycemic controlSGLT2 inhibitorType 2 diabetes

Identifiers

PMID29159457
PMCPMC5801223
OpenAlexW2769581384

What OpenQuestion holds

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LicenceCC BY-NC
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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.