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Mexican population sub-analysis of the lixilan clinical program with the fixed ratio combination of insulin glargine and lixisenatide (iGlarLixi).
J Diabetes Complications. 2020 Aug; 34(8):107389.JD

Abstract

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.

Authors+Show Affiliations

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.Medical Diabetes Division, Sanofi México, Avenida Universidad 1738, Col. Coyoacán Centro, Coyoacán 04000, CDMX, Mexico.. Electronic address: miriam.diaz@sanofi.com.Medical Diabetes Division, Sanofi México, Avenida Universidad 1738, Col. Coyoacán Centro, Coyoacán 04000, CDMX, Mexico.. Electronic address: JuanFrancisco.Llamas@sanofi.com.Medical Diabetes Division, Sanofi México, Avenida Universidad 1738, Col. Coyoacán Centro, Coyoacán 04000, CDMX, Mexico.. Electronic address: Karla.Fernandez@sanofi.com.Medical Diabetes Division, Sanofi México, Avenida Universidad 1738, Col. Coyoacán Centro, Coyoacán 04000, CDMX, Mexico.. Electronic address: MariaElena.Sanudo@sanofi.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32561160

Citation

González-Gálvez, G, et al. "Mexican Population Sub-analysis of the Lixilan Clinical Program With the Fixed Ratio Combination of Insulin Glargine and Lixisenatide (iGlarLixi)." Journal of Diabetes and Its Complications, vol. 34, no. 8, 2020, p. 107389.
González-Gálvez G, Díaz-Toscano ML, Llamas-Moreno JF, et al. Mexican population sub-analysis of the lixilan clinical program with the fixed ratio combination of insulin glargine and lixisenatide (iGlarLixi). J Diabetes Complicat. 2020;34(8):107389.
González-Gálvez, G., Díaz-Toscano, M. L., Llamas-Moreno, J. F., Fernández-Rodarte, K., & Sañudo-Maury, M. E. (2020). Mexican population sub-analysis of the lixilan clinical program with the fixed ratio combination of insulin glargine and lixisenatide (iGlarLixi). Journal of Diabetes and Its Complications, 34(8), 107389. https://doi.org/10.1016/j.jdiacomp.2019.05.020
González-Gálvez G, et al. Mexican Population Sub-analysis of the Lixilan Clinical Program With the Fixed Ratio Combination of Insulin Glargine and Lixisenatide (iGlarLixi). J Diabetes Complicat. 2020;34(8):107389. PubMed PMID: 32561160.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Mexican population sub-analysis of the lixilan clinical program with the fixed ratio combination of insulin glargine and lixisenatide (iGlarLixi). AU - González-Gálvez,G, AU - Díaz-Toscano,M L, AU - Llamas-Moreno,J F, AU - Fernández-Rodarte,K, AU - Sañudo-Maury,M E, Y1 - 2019/05/31/ PY - 2018/11/28/received PY - 2019/04/30/revised PY - 2019/05/25/accepted PY - 2020/6/21/pubmed PY - 2020/6/21/medline PY - 2020/6/21/entrez KW - Insulin glargine KW - LixiLan KW - Lixisenatide KW - Mexican population KW - T2DM KW - iGlarLixi SP - 107389 EP - 107389 JF - Journal of diabetes and its complications JO - J. Diabetes Complicat. VL - 34 IS - 8 N2 - 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. SN - 1873-460X UR - https://www.unboundmedicine.com/medline/citation/32561160/Mexican_population_sub-analysis_of_the_lixilan_clinical_program_with_the_fixed_ratio_combination_of_insulin_glargine_and_lixisenatide_(iGlarLixi) L2 - https://linkinghub.elsevier.com/retrieve/pii/S1056-8727(18)31286-8 DB - PRIME DP - Unbound Medicine ER -
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