Evidence map›Paper›PMID 29313282›Full record

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

Ertugliflozin and Sitagliptin Co-initiation in Patients with Type 2 Diabetes: The VERTIS SITA Randomized Study.

Sam Miller, Tania Krumins, Haojin Zhou, Susan Huyck, Jeremy Johnson, Gregory Golm, Steven G Terra, James P Mancuso, Samuel S Engel, Brett Lauring

2 registry-linked trialsAbstract 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 2 registered trials, which are not on this map. Cited by 48 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 7 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.

NCT02226003 phase3completednot on this map

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Initial Combination of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Subjects With T2DM With Inadequate Glycemic Control on Diet and Exercise

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2014 to 2016Enrolled291ConditionsType 2 Diabetes MellitusArmsErtugliflozin, Sitagliptin, Placebo to Ertugliflozin, Placebo to Sitagliptin, Glimepiride
NCT05556291 completednot on this mapstarted 2022, after this paper: background citation

Efficacy, Safety & Tolerability of Combination of Ertugliflozin and Sitagliptin in Patients With Type II Diabetes Mellitus

TypeobservationalSponsorGetz PharmaRan2022 to 2024Enrolled190ConditionsEfficacy, Safety, TolerabilityArmsCombinations of Oral Blood Glucose Lowering Drugs
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 7 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

10 authors.

Sam MillerSAM Clinical Research Center, San Antonio, TX, USA.
Tania KruminsMerck & Co., Inc., Kenilworth, NJ, USA.
Haojin ZhouMSD R&D (China) Co., Ltd., Beijing, China.
Susan HuyckMerck & Co., Inc., Kenilworth, NJ, USA.
Jeremy JohnsonMerck & Co., Inc., Kenilworth, NJ, USA.
Gregory GolmMerck & 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

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionErtugliflozin is an oral sodium-glucose cotransporter 2 inhibitor that is being developed to treat type 2 diabetes mellitus (T2DM). This study assessed the efficacy and safety of co-initiation of ertugliflozin and sitagliptin compared with placebo in patients with T2DM inadequately controlled on diet and exercise.

methodsIn this phase III, randomized, double-blind, multicenter, placebo-controlled 26-week study (NCT02226003), patients with T2DM and glycated hemoglobin (HbA1c) 8.0-10.5% on diet/exercise were randomized 1:1:1 to ertugliflozin 5 mg once daily (QD) and sitagliptin 100 mg QD (E5/S100), ertugliflozin 15 mg QD and sitagliptin 100 mg QD (E15/S100), or placebo. The primary efficacy endpoint was the change from baseline in HbA1c at week 26.

resultsThe mean baseline HbA1c of the randomized patients (n = 291) was 8.9%. At week 26, both ertugliflozin/sitagliptin treatments provided significant reductions from baseline in HbA1c compared with placebo [least squares mean HbA1c change (95% confidence intervals) from baseline was - 0.4% (- 0.7, - 0.2), - 1.6% (- 1.8, - 1.4), and - 1.7% (- 1.9, - 1.5) for placebo, E5/S100, and E15/S100, respectively]. At week 26, 8.3%, 35.7%, and 31.3% of patients receiving placebo, E5/S100, and E15/S100, respectively, had HbA1c < 7.0%. Significant reductions in fasting plasma glucose, 2-h post-prandial glucose, body weight, and systolic blood pressure were observed with both ertugliflozin/sitagliptin groups compared with placebo. The incidence of adverse events (AEs) was similar across the groups. The incidences of the pre-specified AEs of urinary tract infection, genital mycotic infection, symptomatic hypoglycemia, and hypovolemia were low and not meaningfully different across groups.

conclusionCo-initiation of ertugliflozin with sitagliptin in patients with T2DM inadequately controlled on diet and exercise provided a clinically meaningful improvement in glycemic control over 26 weeks. CLINICAL

trial registrationClinicaltrials.gov NCT02226003.

Indexed as

ErtugliflozinGlycemic controlSGLT2 inhibitorSitagliptinType 2 diabetes mellitus

Identifiers

PMID29313282
PMCPMC5801244

What Socratic 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 Socratic graph.