Efficacy and safety of evogliptin in the treatment of type 2 diabetes mellitus in a Brazilian population: a randomized bridging study
Autor: | Teresa Bonansea, João Eduardo Nunes Salles, Patricia Muskat, João Lindolfo C. Borges, Luis Augusto Tavares Russo, João Soares Felício, Adriana Costa e Forti, Freddy Goldberg Eliaschewitz, Cintia Cercato, Antonio Roberto Chacra |
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Rok vydání: | 2019 |
Předmět: |
medicine.medical_specialty
endocrine system diseases Endocrinology Diabetes and Metabolism Evogliptin 030209 endocrinology & metabolism Dipeptidyl peptidase-4 inhibitor 030204 cardiovascular system & hematology 03 medical and health sciences 0302 clinical medicine Internal medicine Diabetes mellitus Internal Medicine medicine lcsh:RC620-627 Glycemic business.industry Research Type 2 Diabetes Mellitus Bridging study medicine.disease lcsh:Nutritional diseases. Deficiency diseases Regimen Sitagliptin Type 2 diabetes treatment business Body mass index medicine.drug |
Zdroj: | Diabetology & Metabolic Syndrome Diabetology & Metabolic Syndrome, Vol 11, Iss 1, Pp 1-8 (2019) |
ISSN: | 1758-5996 |
Popis: | 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 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). |
Databáze: | OpenAIRE |
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