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Advancing Therapy in Suboptimally Controlled Basal Insulin–Treated Type 2 Diabetes: Clinical Outcomes With iGlarLixi Versus Premix BIAsp 30 in the SoliMix Randomized Controlled Trial

OBJECTIVE: To directly compare the efficacy and safety of a fixed-ratio combination, of insulin glargine 100 units/mL and the glucagon-like peptide 1 receptor agonist lixisenatide (iGlarLixi), with those of a premix insulin analog, biphasic aspart insulin 30 (30% insulin aspart and 70% insulin aspar...

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Autores principales: Rosenstock, Julio, Emral, Rifat, Sauque-Reyna, Leobardo, Mohan, Viswanathan, Trescolí, Carlos, Al Sifri, Saud, Lalic, Nebojsa, Alvarez, Agustina, Picard, Pascaline, Bonnemaire, Mireille, Demil, Nacima, McCrimmon, Rory J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Diabetes Association 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8740944/
https://www.ncbi.nlm.nih.gov/pubmed/34183429
http://dx.doi.org/10.2337/dc21-0393
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author Rosenstock, Julio
Emral, Rifat
Sauque-Reyna, Leobardo
Mohan, Viswanathan
Trescolí, Carlos
Al Sifri, Saud
Lalic, Nebojsa
Alvarez, Agustina
Picard, Pascaline
Bonnemaire, Mireille
Demil, Nacima
McCrimmon, Rory J.
author_facet Rosenstock, Julio
Emral, Rifat
Sauque-Reyna, Leobardo
Mohan, Viswanathan
Trescolí, Carlos
Al Sifri, Saud
Lalic, Nebojsa
Alvarez, Agustina
Picard, Pascaline
Bonnemaire, Mireille
Demil, Nacima
McCrimmon, Rory J.
author_sort Rosenstock, Julio
collection PubMed
description OBJECTIVE: To directly compare the efficacy and safety of a fixed-ratio combination, of insulin glargine 100 units/mL and the glucagon-like peptide 1 receptor agonist lixisenatide (iGlarLixi), with those of a premix insulin analog, biphasic aspart insulin 30 (30% insulin aspart and 70% insulin aspart protamine) (BIAsp 30) as treatment advancement in type 2 diabetes suboptimally controlled on basal insulin plus oral antihyperglycemic drugs (OADs). RESEARCH DESIGN AND METHODS: In SoliMix, a 26-week, open-label, multicenter study, adults with suboptimally controlled basal insulin–treated type 2 diabetes (HbA(1c) ≥7.5% and ≤10%) were randomized to once-daily iGlarLixi or twice-daily BIAsp 30. Primary efficacy end points were noninferiority in HbA(1c) reduction (margin 0.3%) or superiority in body weight change for iGlarLixi versus BIAsp 30. RESULTS: Both primary efficacy end points were met: after 26 weeks, baseline HbA(1c) (8.6%) was reduced by 1.3% with iGlarLixi and 1.1% with BIAsp 30, meeting noninferiority (least squares [LS] mean difference −0.2% [97.5% CI −0.4, −0.1]; P < 0.001). iGlarLixi was also superior to BIAsp 30 for body weight change (LS mean difference −1.9 kg [95% CI −2.3, −1.4]) and percentage of participants achieving HbA(1c) <7% without weight gain and HbA(1c) <7% without weight gain and without hypoglycemia (all P < 0.001). iGlarLixi was also superior versus BIAsp 30 for HbA(1c) reduction (P < 0.001). Incidence and rates of American Diabetes Association level 1 and 2 hypoglycemia were lower with iGlarLixi versus BIAsp 30. CONCLUSIONS: Once-daily iGlarLixi provided better glycemic control with weight benefit and less hypoglycemia than twice-daily premix BIAsp 30. iGlarLixi is a more efficacious, simpler, and well-tolerated alternative to premix BIAsp 30 in suboptimally controlled type 2 diabetes requiring treatment beyond basal insulin plus OAD therapy. VIDEO 1: [Figure: see text] [Figure: see text]
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spelling pubmed-87409442022-01-10 Advancing Therapy in Suboptimally Controlled Basal Insulin–Treated Type 2 Diabetes: Clinical Outcomes With iGlarLixi Versus Premix BIAsp 30 in the SoliMix Randomized Controlled Trial Rosenstock, Julio Emral, Rifat Sauque-Reyna, Leobardo Mohan, Viswanathan Trescolí, Carlos Al Sifri, Saud Lalic, Nebojsa Alvarez, Agustina Picard, Pascaline Bonnemaire, Mireille Demil, Nacima McCrimmon, Rory J. Diabetes Care Emerging Therapies: Drugs and Regimens OBJECTIVE: To directly compare the efficacy and safety of a fixed-ratio combination, of insulin glargine 100 units/mL and the glucagon-like peptide 1 receptor agonist lixisenatide (iGlarLixi), with those of a premix insulin analog, biphasic aspart insulin 30 (30% insulin aspart and 70% insulin aspart protamine) (BIAsp 30) as treatment advancement in type 2 diabetes suboptimally controlled on basal insulin plus oral antihyperglycemic drugs (OADs). RESEARCH DESIGN AND METHODS: In SoliMix, a 26-week, open-label, multicenter study, adults with suboptimally controlled basal insulin–treated type 2 diabetes (HbA(1c) ≥7.5% and ≤10%) were randomized to once-daily iGlarLixi or twice-daily BIAsp 30. Primary efficacy end points were noninferiority in HbA(1c) reduction (margin 0.3%) or superiority in body weight change for iGlarLixi versus BIAsp 30. RESULTS: Both primary efficacy end points were met: after 26 weeks, baseline HbA(1c) (8.6%) was reduced by 1.3% with iGlarLixi and 1.1% with BIAsp 30, meeting noninferiority (least squares [LS] mean difference −0.2% [97.5% CI −0.4, −0.1]; P < 0.001). iGlarLixi was also superior to BIAsp 30 for body weight change (LS mean difference −1.9 kg [95% CI −2.3, −1.4]) and percentage of participants achieving HbA(1c) <7% without weight gain and HbA(1c) <7% without weight gain and without hypoglycemia (all P < 0.001). iGlarLixi was also superior versus BIAsp 30 for HbA(1c) reduction (P < 0.001). Incidence and rates of American Diabetes Association level 1 and 2 hypoglycemia were lower with iGlarLixi versus BIAsp 30. CONCLUSIONS: Once-daily iGlarLixi provided better glycemic control with weight benefit and less hypoglycemia than twice-daily premix BIAsp 30. iGlarLixi is a more efficacious, simpler, and well-tolerated alternative to premix BIAsp 30 in suboptimally controlled type 2 diabetes requiring treatment beyond basal insulin plus OAD therapy. VIDEO 1: [Figure: see text] [Figure: see text] American Diabetes Association 2021-10 2021-08-06 /pmc/articles/PMC8740944/ /pubmed/34183429 http://dx.doi.org/10.2337/dc21-0393 Text en © 2021 by the American Diabetes Association https://www.diabetesjournals.org/content/licenseReaders may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at https://www.diabetesjournals.org/content/license.
spellingShingle Emerging Therapies: Drugs and Regimens
Rosenstock, Julio
Emral, Rifat
Sauque-Reyna, Leobardo
Mohan, Viswanathan
Trescolí, Carlos
Al Sifri, Saud
Lalic, Nebojsa
Alvarez, Agustina
Picard, Pascaline
Bonnemaire, Mireille
Demil, Nacima
McCrimmon, Rory J.
Advancing Therapy in Suboptimally Controlled Basal Insulin–Treated Type 2 Diabetes: Clinical Outcomes With iGlarLixi Versus Premix BIAsp 30 in the SoliMix Randomized Controlled Trial
title Advancing Therapy in Suboptimally Controlled Basal Insulin–Treated Type 2 Diabetes: Clinical Outcomes With iGlarLixi Versus Premix BIAsp 30 in the SoliMix Randomized Controlled Trial
title_full Advancing Therapy in Suboptimally Controlled Basal Insulin–Treated Type 2 Diabetes: Clinical Outcomes With iGlarLixi Versus Premix BIAsp 30 in the SoliMix Randomized Controlled Trial
title_fullStr Advancing Therapy in Suboptimally Controlled Basal Insulin–Treated Type 2 Diabetes: Clinical Outcomes With iGlarLixi Versus Premix BIAsp 30 in the SoliMix Randomized Controlled Trial
title_full_unstemmed Advancing Therapy in Suboptimally Controlled Basal Insulin–Treated Type 2 Diabetes: Clinical Outcomes With iGlarLixi Versus Premix BIAsp 30 in the SoliMix Randomized Controlled Trial
title_short Advancing Therapy in Suboptimally Controlled Basal Insulin–Treated Type 2 Diabetes: Clinical Outcomes With iGlarLixi Versus Premix BIAsp 30 in the SoliMix Randomized Controlled Trial
title_sort advancing therapy in suboptimally controlled basal insulin–treated type 2 diabetes: clinical outcomes with iglarlixi versus premix biasp 30 in the solimix randomized controlled trial
topic Emerging Therapies: Drugs and Regimens
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8740944/
https://www.ncbi.nlm.nih.gov/pubmed/34183429
http://dx.doi.org/10.2337/dc21-0393
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