Evidence map›Paper›PMID 28345162›Full record

Trial reportDiabetes, obesity & metabolism2017

Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study).

Yuichiro Yamada, Masayuki Senda, Yusuke Naito, Masahiro Tamura, Daisuke Watanabe, Yujin Shuto, Yoshihisa Urita

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IVComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02200991 (A Randomized, Multicenter, Open-Label, Parallel-Group, 28 Days Phase IV Study Comparing The Postprandial Plasma Glucose Profile of Lixisenatide With That of Sitagliptin Add-On to Insulin Glargine in Type 2 Diabetes Mellitus), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 32% 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.

NCT02200991 phase4completednot on this map

A Randomized, Multicenter, Open-Label, Parallel-Group, 28 Days Phase IV Study Comparing The Postprandial Plasma Glucose Profile of Lixisenatide With That of Sitagliptin Add-On to Insulin Glargine in Type 2 Diabetes Mellitus

TypeinterventionalSponsorSanofiRan2014 to 2015Enrolled136ConditionsType 2 Diabetes MellitusArmsLIXISENATIDE AVE0010, Sitagliptin, Insulin glargine HOE901
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Evolving Pharmacotherapeutic Strategies for Type 1 Diabetes Mellitus.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG
    Review
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

7 authors at 3 institutions in 1 country.

Yuichiro YamadaDepartment of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine and Faculty of Medicine, Akita, Japan.
Masayuki SendaMedical Affairs, Sanofi K.K., Tokyo, Japan.
Yusuke NaitoDiabetes and Cardiovascular Medical Operations, Sanofi K.K., Tokyo, Japan.ORCID 0000-0001-8033-6708
Masahiro TamuraDiabetes and Cardiovascular Medical Operations, Sanofi K.K., Tokyo, Japan.
Daisuke WatanabeBiostatistics and Programming, Sanofi K.K., Tokyo, Japan.
Yujin ShutoDiabetes and Cardiovascular Medical Operations, Sanofi K.K., Tokyo, Japan.
Yoshihisa UritaDepartment of General Medicine and Emergency Care, Toho University School of Medicine, Omori Hospital, Tokyo, Japan.
Sanofi (Japan) · JPAkita University · JPToho University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate the pharmacodynamics of lixisenatide once daily vs sitagliptin once daily in Japanese patients with type 2 diabetes receiving insulin glargine U100. MATERIALS AND

methodsThis multicentre, open-label, phase IV study (NEXTAGE Study; ClinicalTrials.gov number, NCT02200991) randomly assigned 136 patients to either lixisenatide once daily via subcutaneous injection (10 µg initially increased weekly by 5 up to 20 µg) or once-daily oral sitagliptin 50 mg. The primary endpoint was the change in postprandial glucose (PPG) exposure 4 hours after a standardized breakfast (PPG area under the plasma glucose concentration-time curve [AUC

resultsLixisenatide reduced PPG exposure to a statistically significantly greater extent than sitagliptin: least squares (LS) mean change from baseline in PPG AUC

conclusionLixisenatide reduced PPG significantly more than sitagliptin, when these agents were added to basal insulin glargine U100, and was well tolerated.

Indexed as

Glucagon-Like Peptide-1 Receptor AgonistsAdministration, OralAgedBiomarkersDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDose-Response Relationship, DrugDrug Administration ScheduleDrug ResistanceDrug Therapy, CombinationFemaleFollow-Up StudiesGastric EmptyingGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinBiomarkersDipeptidyl-Peptidase IV InhibitorsGLP1R protein, humanGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like Peptide-2 ReceptorGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin GlarginelixisenatidePeptidesSitagliptin Phosphategastric emptyingglucagon-like peptide 1 receptor agonistlixisenatidepostprandial glucoserandomized trialtype 2 diabetes mellitus

Identifiers

PMID28345162
PMCPMC5573929
OpenAlexW2602373503

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.