Evidence map›Paper›PMID 30830724›Full record

Trial reportDiabetes, obesity & metabolism2019

Safety and efficacy of ertugliflozin in Asian patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: VERTIS Asia.

Linong Ji, Yanmei Liu, Heng Miao, Yongli Xie, Ming Yang, Wei Wang, Yuting Mu, Ping Yan, Sharon Pan, Brett Lauring and 4 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 NCT02630706. Cited by 37 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 15 pooled it
–field-weighted citation impact
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.

NCT02630706 phase3completed

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformin Monotherapy (VERTIS-ASIA)

Ran2015Enrolled506Registered outcomes34Posted comparisons36ConditionsType 2 Diabetes MellitusArmsErtugliflozin 15 mg, Ertugliflozin 5 mg, Glimepiride, Metformin, Placebo matching ertugliflozin
Open the trial in the graph
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 15 syntheses or guidelines pooled it.

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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

14 authors.

Linong JiPeking University People's Hospital, Beijing, China.ORCID 0000-0003-1305-1598
Yanmei LiuYancheng First People's Hospital, Yancheng, China.
Heng MiaoThe Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Yongli XiePingxiang People's Hospital, Pingxiang, China.
Ming YangPfizer (China) R&D Co., Shanghai, China.
Wei WangPfizer (China) R&D Co., Shanghai, China.
Yuting MuPfizer (China) R&D Co., Shanghai, China.
Ping YanPfizer (China) R&D Co., Shanghai, China.
Sharon PanPfizer Inc., New York, New York.
Brett LauringMerck & Co., Inc., Kenilworth, New Jersey.
Shu LiuMSD China, Beijing, China.
Susan HuyckMerck & Co., Inc., Kenilworth, New Jersey.
Yanping QiuMSD China, Beijing, China.
Steven G TerraPfizer Inc., Andover, Massachusetts.ORCID 0000-0002-5815-6193

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimPhase III, randomized, double-blind study evaluating the efficacy and safety of ertugliflozin in Asian patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin, including evaluation in the China subpopulation. MATERIALS AND

methodsA 26-week, double-blind study of 506 Asian patients (80.2% from mainland China), randomized 1:1:1 to placebo, ertugliflozin 5- or 15 mg, was performed. Primary endpoint was change from baseline in HbA1c at week 26. Secondary endpoints were change from baseline at week 26 in fasting plasma glucose (FPG), body weight (BW), systolic/diastolic blood pressure (SBP/DBP), and proportion of patients with HbA1c <7.0%. Hypotheses for the primary endpoint and FPG and BW secondary endpoints were tested in the China subpopulation.

resultsAt week 26, least squares mean (95% CI) change from baseline HbA1c was significantly greater with ertugliflozin 5- and 15 mg versus placebo: -1.0% (-1.1, -0.9), -0.9% (-1.0, -0.8), -0.2% (-0.3, -0.1), respectively. Ertugliflozin significantly reduced FPG, BW and SBP. Reductions in DBP with ertugliflozin were not significant. At week 26, 16.2%, 38.2% and 40.8% of patients had HbA1c <7.0% with placebo, ertugliflozin 5- and 15 mg, respectively. 59.3%, 56.5% and 53.3% of patients experienced adverse events with placebo, ertugliflozin 5- and 15 mg, respectively. Incidence of symptomatic hypoglycaemia was higher for ertugliflozin 15 mg vs placebo. Results in the China subpopulation were consistent.

conclusionsErtugliflozin significantly improved glycaemic control and reduced BW and SBP in Asian patients with T2DM. Ertugliflozin was generally well-tolerated. Results in the China subpopulation were consistent with the overall population. ClinicalTrials.gov: NCT02630706.

Indexed as

AgedAsia, EasternBridged Bicyclo Compounds, HeterocyclicDiabetes Mellitus, Type 2Drug-Related Side Effects and Adverse ReactionsFemaleHumansMaleMetforminMiddle AgedPhilippinesSodium-Glucose Transporter 2 InhibitorsBridged Bicyclo Compounds, HeterocyclicertugliflozinMetforminSodium-Glucose Transporter 2 InhibitorsAsiaertugliflozinSGLT2 inhibitortype 2 diabetes mellitus

Identifiers

PMID30830724
PMCPMC7379575

What Socratic 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 Socratic graph.