Evidence map›Paper›PMID 31890041›Full record

ArticleDiabetology & metabolic syndrome2019

Efficacy and safety of evogliptin in the treatment of type 2 diabetes mellitus in a Brazilian population: a randomized bridging study.

Cintia Cercato, Joao Soares Felício, Luis Augusto Tavares Russo, Joao Lindolfo Cunha Borges, Joao Salles, Patricia Muskat, Teresa Bonansea, Antonio Roberto Chacra, Freddy Goldberg Eliaschewitz, Adriana Costa Forti

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetology & metabolic syndrome, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 20% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
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 4 institutions in 1 country.

Cintia Cercato1Laboratório de Lípides (LIM 10) do Hospital das Clínicas (HCFMUSP) da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brasil, 155 Dr Enéas de Carvalho de Aguiar ave., São Paulo, SP 05403-000 Brazil.
Joao Soares FelícioHospital Universitário João de Barros Barreto (HUJBB), 4487 Mundurucus st., Belém, PA 66073-005 Brazil.
Luis Augusto Tavares RussoCCBR Brasil - Centro de Pesquisas e Análises Clínicas Ltda., 33 Mena Barreto st., Rio de Janeiro, RJ 22271-100 Brazil.
Joao Lindolfo Cunha BorgesCEM - Clínica de Endocrinologia e Metabologia Ltda., SHIS QI 09 Bloco E1 304/305, Brasília, DF 71625-175 Brazil.
Joao SallesInstituto de Pesquisa Clínica Ltda., 503 Marquês de Itú st., São Paulo, SP 01223-001 Brazil.
Patricia MuskatIMA - Instituto de Pesquisa Clínica e Medicina Avançada Ltda., 55 Américo Jacomino sq., São Paulo, SP 05437-010 Brazil.
Teresa BonanseaCentro Paulista de Investigação Clínica, 342 Moreira e Costa st., São Paulo, SP 04266-010 Brazil.
Antonio Roberto Chacra8Centro de Pesquisa Clínica em Diabetes da UNIFESP, 639 Estado de Israel st., São Paulo, SP 04022-001 Brazil.
Freddy Goldberg EliaschewitzCPCLIN - Centro de Pesquisas Clínicas Ltda., Avenida Angélica 2162, São Paulo, SP 01228-200 Brazil.
Adriana Costa FortiCentro de Estudos em Diabetes e Hipertensão (CEDH), 2434 Dr Jose Lourenço st., Fortaleza, CE 60115-282 Brazil.
Centro Paulista de Investigação Clinica · BRHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRHospital das Clínicas da Universidade Federal de Pernambuco · BRHospital Geral de Bonsucesso · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEvogliptin (EVO) is a potent and selective dipeptidyl peptidase-4 inhibitor (DPP4i) developed for the treatment of type 2 diabetes mellitus (T2DM). DPP4is are known to exhibit a better glucose-lowering effect in Asians compared to other ethnic groups. Once EVO's clinical development program was conducted in Asian patients, this bridging study was designed to validate for the Brazilian population the efficacy and safety of the approved dose regimen (once-daily 5.0 mg).

methodsIn this randomized, double-blind, double-dummy, parallel trial, 146 patients with T2DM with inadequate glycemic control on diet and exercise (7.5% ≤ HbA1c ≤ 10.5%) were randomly assigned to a 12-week once-daily treatment with EVO 2.5 mg (N = 35), EVO 5 mg (N = 36), EVO 10 mg (N = 36), or sitagliptin (SITA) 100 mg (N = 39). Absolute changes (Week 12-baseline) in HbA1c, fasting plasma glucose (FPG) and body weight (BW) were obtained. One-sided one sample t test was used to determine if mean HbA1c reduction in each group was < - 0.5% (beneficial metabolic response). An analysis of covariance estimated the change in HbA1c and FPG adjusted by baseline HbA1c, FPG, body mass index (BMI) and study site. Response rates to treatment were also established. No between-group statistical comparisons were planned.

resultsHbA1c mean reductions were - 1.26% (90% CI - 1.7%, - 0.8%), - 1.12% (90% CI - 1.4%, - 0.8%), - 1.29% (90% CI - 1.6%, - 1.0%), and - 1.15% (90% CI - 1.5%, - 0.8%) in groups EVO 2.5 mg, EVO 5 mg, EVO 10 mg, and SITA 100 mg, respectively. FPG levels showed a mean increase of 10.89 mg/dL in group EVO 2.5 mg, with significant mean reductions of - 18.94 mg/dL, - 21.17 mg/dL, and - 39.90 mg/dL in those treated with EVO 5 mg, EVO 10 mg, and SITA 100 mg, respectively. BW showed significant reductions of approximately 1 kg in patients treated with EVO 5 mg, EVO 10 mg, and SITA 100 mg. Mean adjusted reductions of HbA1c and FPG levels confirmed the significant clinical benefit of all study treatments. The clinical benefit of EVO's "target" dose (5 mg) was confirmed. No safety concerns were identified.

conclusionsThese results validate for the Brazilian population the approved dose regimen of EVO (once-daily 5 mg).

Indexed as

Bridging studyDipeptidyl peptidase-4 inhibitorEvogliptinType 2 diabetes treatment

Identifiers

PMID31890041
PMCPMC6923891
OpenAlexW2994897050

What OpenQuestion holds

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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.