Evidence map›Paper›PMID 28058750›Full record

Trial reportDiabetes, obesity & metabolism2017

Efficacy and safety of adding evogliptin versus sitagliptin for metformin-treated patients with type 2 diabetes: A 24-week randomized, controlled trial with open label extension.

Sang-Mo Hong, Cheol-Young Park, Dong-Min Hwang, Kyung Ah Han, Chang Beom Lee, Choon Hee Chung, Kun-Ho Yoon, Ji-Oh Mok, Kyong Soo Park, Sung-Woo Park

Open access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
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 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 11% 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.

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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 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

10 authors at 9 institutions in 3 countries.

Sang-Mo HongDepartment of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Republic of Korea.ORCID 0000-0002-8535-0565
Cheol-Young ParkDepartment of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Dong-Min HwangData Management and Clinical Statistics Team, Dong-A ST, Seoul, Republic of Korea.
Kyung Ah HanDepartment of Internal Medicine, Eulji University College of Medicine, Daejeon, Republic of Korea.
Chang Beom LeeDepartment of Internal Medicine, College of Medicine, Hanyang University, Seoul, Republic of Korea.
Choon Hee ChungDepartment of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.
Kun-Ho YoonDepartment of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Ji-Oh MokDepartment of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon-si, Republic of Korea.
Kyong Soo ParkDepartment of Internal Medicine, College of Medicine, Seoul National University, Seoul, Republic of Korea.
Sung-Woo ParkDepartment of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Kangbuk Samsung Hospital · KRCatholic University of Korea · KRDong-A ST (South Korea) · KREulji University · KRHallym University Dongtan Sacred Heart Hospital · KRHanyang University · KRSeoul National University · KRSoonchunhyang University · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThis trial consisted of a 24-week multicentre, randomized, double-blind, double-dummy, active-controlled study and a 52-week open label extension study to assess the efficacy and safety of evogliptin, a novel dipeptidyl peptidase-4 inhibitor, compared to sitagliptin in patients with type 2 diabetes who have inadequate glycaemic control with metformin alone.

methodsAdult patients with type 2 diabetes mellitus (N = 222) with HbA1c 6.5% to 11% who were receiving stable doses of metformin (≥1000 mg/d) were randomized 1:1 to add-on evogliptin 5 mg (N = 112) or sitagliptin 100 mg (N = 110) once daily for 24 weeks. The primary efficacy analysis consisted of a comparison of the change from baseline HbA1c at week 24. Non-inferiority was concluded if the upper limit of the 2-sided 95% confidence interval for the HbA1c difference between treatments was <0.35%.

resultsMean changes in HbA1c following addition of evogliptin or sitagliptin were -0.59% and -0.65%, respectively. The between-group difference was 0.06% (2-sided 95% confidence interval, -0.10 to 0.22), demonstrating non-inferiority. After the 52-week treatment, evogliptin caused a persistently decreased level of HbA1c (-0.44% ± 0.65%, P  < .0001). In general, both treatments were well tolerated, with incidences and types of adverse events comparable between the two groups. Hypoglycaemic events, mostly mild, were reported in 0.9% of patients treated with evogliptin and in 2.8% of patients treated with sitagliptin for 24 weeks.

conclusionsEvogliptin 5 mg added to metformin therapy effectively improved glycaemic control and was non-inferior to sitagliptin and well tolerated in patients with type 2 diabetes mellitus that was inadequately controlled by metformin alone.

Indexed as

AgedDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDrug MonitoringDrug ResistanceDrug Therapy, CombinationFemaleFollow-Up StudiesGlycated HemoglobinHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsIncidenceMaleMetformin4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-oneDipeptidyl-Peptidase IV InhibitorsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsMetforminPiperazinesSitagliptin Phosphatecombination therapyDPP-4 inhibitorevogliptinmetforminsitagliptintype 2 diabetes mellitus

Identifiers

PMID28058750
PMCPMC5412933
OpenAlexW2569951022

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.