Evidence map›Paper›PMID 28448688›Full record

Trial reportDiabetes, obesity & metabolism2017

Efficacy and safety of evogliptin monotherapy in patients with type 2 diabetes and moderately elevated glycated haemoglobin levels after diet and exercise.

Juri Park, Sung Woo Park, Kun Ho Yoon, Sung Rae Kim, Kyu Jeung Ahn, Jae Hyuk Lee, Ji Oh Mok, Choon Hee Chung, Kyung Ah Han, Gwan Pyo Koh and 5 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
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. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 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

15 authors.

Juri ParkDepartment of Endocrinology and Metabolism, Division of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.ORCID 0000-0002-7463-8686
Sung Woo ParkDepartment of Endocrinology and Metabolism, Division of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.ORCID 0000-0002-8535-0565
Kun Ho YoonDepartment of Endocrinology and Metabolism, Division of Internal Medicine, Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea.
Sung Rae KimDepartment of Endocrinology and Metabolism, Division of Internal Medicine, Bucheon St. Mary's Hospital, Catholic University of Korea, Bucheon, Korea.
Kyu Jeung AhnDepartment of Endocrinology and Metabolism, Division of Internal Medicine, Kangdong Kyung Hee Hospital, Kyung Hee University School of Medicine, Seoul, Korea.
Jae Hyuk LeeDepartment of Endocrinology and Metabolism, Division of Internal Medicine, Myongji Hospital, Kwandong University College of Medicine, Koyang, Korea.
Ji Oh MokDepartment of Endocrinology and Metabolism, Division of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea.
Choon Hee ChungDepartment of Endocrinology and Metabolism, Division of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.ORCID 0000-0003-1144-7206
Kyung Ah HanDepartment of Endocrinology and Metabolism, Division of Internal Medicine, Eulji University School of Medicine, Daejeon, Korea.
Gwan Pyo KohDepartment of Endocrinology and Metabolism, Division of Internal Medicine, Jeju National University School of Medicine, Jeju, Korea.
Jun Goo KangDepartment of Endocrinology and Metabolism, Division of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea.
Chang Beom LeeDepartment of Endocrinology and Metabolism, Division of Internal Medicine, Hanyang University Guri Hospital, Hanyang University Medical School, Guri, Korea.
Seong Hwan KimDepartment of Cardiology, Division of Internal Medicine, Korea University Ansan Hospital, Ansan, Korea.
Na Young KwonDivision of Biostatistics, Clinical Development Team, Dong-A ST Co., LTD., Seoul, Korea.
Doo Man KimDepartment of Endocrinology and Metabolism, Division of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo evaluate the efficacy and safety of evogliptin, a newly developed dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes (T2D) inadequately controlled by diet and exercise. MATERIALS AND

methodsIn this randomized, double-blind, placebo-controlled, parallel-group, multicentre, phase III study, 160 patients with T2D were assigned to either evogliptin 5 mg or placebo for 24 weeks. The primary endpoint was the mean change in glycated haemoglobin (HbA1c) from baseline to week 24.

resultsThe mean baseline HbA1c levels were similar in the evogliptin and the placebo groups (7.20% ± 0.56% vs 7.20% ± 0.63%, respectively). At week 24, evogliptin significantly reduced HbA1c levels from baseline compared with placebo (-0.23% vs 0.05%, respectively, P < .0001). Additionally, the proportion of patients achieving HbA1c <6.5% was significantly higher in the evogliptin group than in the placebo group (33.3% vs 15.2%; P = .008). The overall incidence of adverse events, including hypoglycaemia, was similar in the 2 groups.

conclusionsIn this 24-week study, once-daily evogliptin monotherapy significantly improved glycaemic control and was well tolerated in patients with T2D.

Indexed as

AgedBlood GlucoseCombined Modality TherapyDiabetes Mellitus, Type 2Diet, DiabeticDipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodExerciseFemaleGlycated HemoglobinHumansHyperglycemiaHypoglycemiaInsulin ResistanceLost to Follow-UpMale4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-oneBlood GlucoseDipeptidyl-Peptidase IV InhibitorsGlycated Hemoglobinhemoglobin A1c protein, humanPiperazinesantidiabetic drugclinical trialDPP-4 inhibitorphase III studytype 2 diabetes

Identifiers

PMID28448688
PMCPMC5697645

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Registered trials

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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.