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

Autor: Cercato C; 1Laboratório 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., Felício JS; Hospital Universitário João de Barros Barreto (HUJBB), 4487 Mundurucus st., Belém, PA 66073-005 Brazil., Russo LAT; CCBR Brasil - Centro de Pesquisas e Análises Clínicas Ltda., 33 Mena Barreto st., Rio de Janeiro, RJ 22271-100 Brazil., Borges JLC; CEM - Clínica de Endocrinologia e Metabologia Ltda., SHIS QI 09 Bloco E1 304/305, Brasília, DF 71625-175 Brazil., Salles J; Instituto de Pesquisa Clínica Ltda., 503 Marquês de Itú st., São Paulo, SP 01223-001 Brazil., Muskat P; IMA - Instituto de Pesquisa Clínica e Medicina Avançada Ltda., 55 Américo Jacomino sq., São Paulo, SP 05437-010 Brazil., Bonansea T; Centro Paulista de Investigação Clínica, 342 Moreira e Costa st., São Paulo, SP 04266-010 Brazil., Chacra AR; 8Centro de Pesquisa Clínica em Diabetes da UNIFESP, 639 Estado de Israel st., São Paulo, SP 04022-001 Brazil., Eliaschewitz FG; CPCLIN - Centro de Pesquisas Clínicas Ltda., Avenida Angélica 2162, São Paulo, SP 01228-200 Brazil., Forti AC; Centro de Estudos em Diabetes e Hipertensão (CEDH), 2434 Dr Jose Lourenço st., Fortaleza, CE 60115-282 Brazil.
Jazyk: angličtina
Zdroj: Diabetology & metabolic syndrome [Diabetol Metab Syndr] 2019 Dec 19; Vol. 11, pp. 107. Date of Electronic Publication: 2019 Dec 19 (Print Publication: 2019).
DOI: 10.1186/s13098-019-0505-z
Abstrakt: Background: Evogliptin (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).
Methods: In 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.
Results: HbA1c 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.
Conclusions: These results validate for the Brazilian population the approved dose regimen of EVO (once-daily 5 mg). Trial registration ClinicalTrials.gov Identifier: NCT02689362 (first posted on 02/23/2016).
Competing Interests: Competing interestsACF, JSF, JLCB, CC—Received financial support for the research and is a speaker for Eurofarma Laboratórios S.A. LATR, JS, PM, TB, ARC, FE—Received financial support for the research.
(© The Author(s) 2019.)
Databáze: MEDLINE
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