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

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...

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Published in:Diabetology and metabolic syndrome 2019-12, Vol.11 (1), p.107-107, Article 107
Main Authors: Cercato, Cintia, Felício, Joao Soares, Russo, Luis Augusto Tavares, Borges, Joao Lindolfo Cunha, Salles, Joao, Muskat, Patricia, Bonansea, Teresa, Chacra, Antonio Roberto, Eliaschewitz, Freddy Goldberg, Forti, Adriana Costa
Format: Article
Language:English
Subjects:
Asians
Body weight
Bridging study
Clinical trials
Comparative analysis
Diabetes mellitus
Diabetes therapy
Dipeptidyl peptidase-4 inhibitor
Drug therapy
Evogliptin
Fasting
Glucose
Glycosylated hemoglobin
Hypoglycemic agents
Medical research
Sitagliptin
Type 2 diabetes
Type 2 diabetes treatment
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Summary: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). 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 
ISSN:1758-5996
1758-5996
DOI:10.1186/s13098-019-0505-z