Evidence map›Paper›PMID 29282633›Full record

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

Ertugliflozin Compared with Glimepiride in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin: The VERTIS SU Randomized Study.

Priscilla Hollander, Jie Liu, Julie Hill, Jeremy Johnson, Zhi Wei Jiang, Gregory Golm, Susan Huyck, Steven G Terra, James P Mancuso, Samuel S Engel and 1 more

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 reports registered trial NCT01999218. Cited by 53 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 13 pooled it
9.6field-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.

NCT01999218 phase3completed

A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Ertugliflozin (MK-8835/PF-04971729) Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

Ran2013Enrolled1,326Registered outcomes6Posted comparisons12ConditionsType 2 Diabetes MellitusArmsErtugliflozin 10 mg, Ertugliflozin 5 mg, Glimerpiride, Metformin, Placebo to Ertugliflozin
PMID 30760125other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 13 syntheses or guidelines pooled it, 108 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

11 authors at 2 institutions in 1 country.

Priscilla HollanderBaylor Endocrine Center, Dallas, TX, USA.
Jie LiuMerck & Co., Inc., Kenilworth, NJ, USA.
Julie HillMerck & Co., Inc., Kenilworth, NJ, USA.
Jeremy JohnsonMerck & Co., Inc., Kenilworth, NJ, USA.
Zhi Wei JiangMSD R&D (China) Co., Ltd, Beijing, China.
Gregory GolmMerck & 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.
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) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study assessed the safety and efficacy of ertugliflozin (an oral sodium-glucose cotransporter 2 inhibitor) vs. glimepiride in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin.

methodsThis phase III, double-blind, non-inferiority study (NCT01999218) randomized patients with HbA1c ≥ 7.0% and ≤ 9.0% on stable metformin ≥ 1500 mg/day 1:1:1 to ertugliflozin 15 or 5 mg once-daily (QD), or glimepiride (titrated from 1 mg QD). The primary hypothesis was that ertugliflozin 15 mg was non-inferior to glimepiride on HbA1c (non-inferiority criterion: upper bound of the 95% confidence interval [CI] about the treatment difference < 0.3%).

resultsMean baseline HbA1c of randomized patients (N = 1326) was 7.8%. Mean and median doses of glimepiride were 3.0 mg/day throughout the study. At week 52, the least squares mean change (95% CI) from baseline in HbA1c was - 0.6% (- 0.7, - 0.5), - 0.6% (- 0.6, - 0.5), and - 0.7% (- 0.8, - 0.7) in the ertugliflozin 15 mg, ertugliflozin 5 mg, and glimepiride groups, respectively. The between-group difference for ertugliflozin 15 mg and glimepiride of 0.1% (- 0.0, 0.2) met the pre-specified non-inferiority criterion. Relative to glimepiride, greater body weight and systolic blood pressure (SBP) reductions were observed with ertugliflozin. The overall incidence of adverse events (AEs) was similar across groups. The incidence of symptomatic hypoglycemia and genital mycotic infection (GMI) were, respectively, lower and higher with ertugliflozin relative to glimepiride. The incidences of urinary tract infection and hypovolemia AEs were not meaningfully different among the groups.

conclusionsErtugliflozin 15 mg was non-inferior to glimepiride in reducing HbA1c when added to metformin in patients with T2DM. Ertugliflozin had an acceptable safety profile and resulted in less hypoglycemia and more GMIs than glimepiride. CLINICAL

trial registrationClinicaltrials.gov NCT01999218.

Indexed as

ErtugliflozinGlycemic controlSodium-glucose cotransporter 2 inhibitorSulfonylureaType 2 diabetes mellitus

Identifiers

PMID29282633
PMCPMC5801240
OpenAlexW2776047972

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.