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Mexican population sub-analysis of the lixilan clinical program with the fixed ratio combination of insulin glargine and lixisenatide (iGlarLixi).
González-Gálvez, G; Díaz-Toscano, M L; Llamas-Moreno, J F; Fernández-Rodarte, K; Sañudo-Maury, M E.
Afiliação
  • González-Gálvez G; Jalisco Institute of Diabetes and Obesity Research S. C., CUCS University of Guadalajara, Endocrinology Department, Hospital Civil de Guadalajara "Dr. Juan I. Menchaca,", Guadalajara, Mexico.
  • Díaz-Toscano ML; Medical Diabetes Division, Sanofi México, Avenida Universidad 1738, Col. Coyoacán Centro, Coyoacán 04000, CDMX, Mexico.. Electronic address: miriam.diaz@sanofi.com.
  • Llamas-Moreno JF; Medical Diabetes Division, Sanofi México, Avenida Universidad 1738, Col. Coyoacán Centro, Coyoacán 04000, CDMX, Mexico.. Electronic address: JuanFrancisco.Llamas@sanofi.com.
  • Fernández-Rodarte K; Medical Diabetes Division, Sanofi México, Avenida Universidad 1738, Col. Coyoacán Centro, Coyoacán 04000, CDMX, Mexico.. Electronic address: Karla.Fernandez@sanofi.com.
  • Sañudo-Maury ME; Medical Diabetes Division, Sanofi México, Avenida Universidad 1738, Col. Coyoacán Centro, Coyoacán 04000, CDMX, Mexico.. Electronic address: MariaElena.Sanudo@sanofi.com.
J Diabetes Complications ; 34(8): 107389, 2020 08.
Article em En | MEDLINE | ID: mdl-32561160
AIM: To evaluate the efficacy and safety of iGlarLixi in Mexican patients with type 2 diabetes who participated in the LixiLan clinical trials and compare results with the rest of the patients. METHODS: Data was collected for Mexican patients who participated in either of three studies: phase 2 trial LixiLan-POC, that compared iGlarLixi vs insulin glargine (iGlar) on inadequately controlled patients with metformin; phase 3 trial LixiLan-O, comparing iGlarLixi vs iGlar and lixisenatide on inadequately controlled patients with oral antidiabetic agents; and finally the phase 3 trial LixiLan-L, comparing iGlarLixi vs iGlar on inadequately controlled patients with basal insulin. The primary endpoint was the change in HbA1c from baseline to end of treatment. RESULTS: In the Mexican population, treatment with iGlarLixi significantly improved HbA1c compared with each component alone achieving an average of 6.5%; (6.17%, 6.63% and 6.73% for the LixiLan-POC, O and L studies respectively) and an average HbA1c reduction from baseline of 1.6%, for the three studies at end of treatment period. CONCLUSION: The efficacy and safety profile of iGlarLixi demonstrate a fair or better composite endpoint of HbA1c without hypoglycemia and no weight gain compared to overall trial population, which could help improve Mexican patients' outcomes.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Peptídeos / Diabetes Mellitus Tipo 2 / Insulina Glargina / Hipoglicemiantes Tipo de estudo: Clinical_trials Limite: Aged / Female / Humans / Male / Middle aged País/Região como assunto: Mexico Idioma: En Revista: J Diabetes Complications Assunto da revista: ENDOCRINOLOGIA Ano de publicação: 2020 Tipo de documento: Article País de afiliação: México País de publicação: Estados Unidos
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Peptídeos / Diabetes Mellitus Tipo 2 / Insulina Glargina / Hipoglicemiantes Tipo de estudo: Clinical_trials Limite: Aged / Female / Humans / Male / Middle aged País/Região como assunto: Mexico Idioma: En Revista: J Diabetes Complications Assunto da revista: ENDOCRINOLOGIA Ano de publicação: 2020 Tipo de documento: Article País de afiliação: México País de publicação: Estados Unidos