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

TY - JOUR

T1 - Advancing therapy in suboptimally controlled basal insulin-treated type 2 diabetes

T2 - Clinical outcomes with iGlarLixi versus premix BIAsp 30 in the SoliMix randomized controlled trial

AU - Rosenstock, Julio

AU - Emral, Rifat

AU - Sauque-Reyna, Leobardo

AU - Mohan, Viswanathan

AU - Trescolí, Carlos

AU - Al Sifri, Saud

AU - Lalic, Nebojsa

AU - Alvarez, Agustina

AU - Picard, Pascaline

AU - Bonnemaire, Mireille

AU - Demil, Nacima

AU - McCrimmon, Rory J.

N1 - Funding Information: Acknowledgments. The authors thank the study participants, trial staff, and investigators for their participation. The authors thank Elisabeth Souhami (Sanofi) for a courtesy review from a medical and scientific perspective, Mathieu Cou-dert (Sanofi) for a courtesy review from a statistical perspective, and Ana Merino-Trigo (Sanofi) for coordinating manuscript development, facilitating author discussions, and review of this manuscript. Editorial assistance was provided by Fishawack Communications Ltd., part of Fisha-wack Health. Duality of Interest. Sponsorship for this study was funded by Sanofi, Paris, France. Editorial assistance provided by Fishawack Communications Ltd. was funded by Sanofi. J.R. has served on advisory panels for Applied Therapeutics, Boehringer Ingelheim, Eli Lilly, Intarcia, Janssen, Novo Nordisk, Oramed, Sanofi, and Zealand and has received research support from Applied Therapeutics, AstraZeneca, Boehringer Ingel-heim, Eli Lilly, Genentech, GlaxoSmithKline, Intar-cia, Janssen, Lexicon, Merck, Novo Nordisk, Oramed, Pfizer, and Sanofi. R.E. has acted as an advisor and speaker for AstraZeneca, Boehringer Ingelheim, Lilly, Merck Sharp & Dohme (MSD), Novo Nordisk, and Sanofi. L.S.-R. has acted as an advisor and speaker for Novo Nordisk, Sanofi, and Boehringer Ingelheim. N.L. has acted as a speaker for Sanofi, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Merck. V.M. has served on advisory panels and has acted as a speaker for Abbott, Boehringer Ingel-heim, Eli Lilly, MSD, Novo Nordisk, Sanofi, and several Indian pharmaceutical companies. He has also received research grants from some of these companies. C.T. has been an investigator in clinical trials for Eli Lilly and Sanofi and has acted as a speaker for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Sanofi. S.A.S. has acted as an advisor and speaker for AstraZeneca, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Novo Nordisk, and Sanofi. A.A., M.B., and N.D. are employees of Sanofi and may hold shares and/or stock options in the company. P.P. is an employee of IviData LIFE SCIENCES working as an external contractor on behalf of Sanofi. R.J.M. has acted as an advisor and speaker for Sanofi and Novo Nordisk. No other potential conflicts of interest relevant to this article were reported. Author Contributions. All named authors meet the International Committee of Medical Journal Editors criteria for authorship for this article. All authors participated in the interpretation of the data and the writing, reviewing, and editing of the manuscript, and had final responsibility for approving the published version. J.R. and P.P. are the guarantors of this work and, as such, had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Prior Presentation. Parts of this study were presented in abstract form and as an oral presentation at the 81st Scientific Sessions of the American Diabetes Association, New Orleans, LA, 25–29 June 2021. Publisher Copyright: © 2021 by the American Diabetes Association.

PY - 2021/10

Y1 - 2021/10

N2 - Objective: To directly compare the efficacy and safety of a fixed-ratio combination, iGlarLixi, with a premix insulin analog (BIAsp 30) as treatment advancement in type 2 diabetes suboptimally controlled on basal insulin plus oral antihyperglycemic drugs (OADs). Research Design and Methods: SoliMix, a 26-week, open-label, multicenter study, randomized adults with suboptimally controlled basal insulin-treated type 2 diabetes (HbA1c ≥7.5 % and ≤10 %) to once-daily iGlarLixi or twice-daily BIAsp 30. Primary efficacy endpoints were non-inferiority in HbA1c reduction (margin 0.3 %) or superiority in bodyweight change for iGlarLixi versus BIAsp 30. Results: Both primary efficacy endpoints were met: after 26 weeks, baseline HbA1c (8.6 %) was reduced by 1.3 % with iGlarLixi and 1.1 % with BIAsp 30, meeting non-inferiority (least squares [LS] mean difference [97.5% CI]: -0.2 [-0.4, -0.1] %; p<0.001). iGlarLixi was also superior to BIAsp 30 for bodyweight change (LS mean difference [95% CI] -1.9 [-2.3, -1.4] kg) and percentage of participants achieving HbA1c <7 % without weight gain and HbA1c <7 % without weight gain and without hypoglycemia (all p<0.001). iGlarLixi was also superior versus BIAsp 30 for HbA1c reduction (p<0.001). Incidence and rates of ADA 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.

AB - Objective: To directly compare the efficacy and safety of a fixed-ratio combination, iGlarLixi, with a premix insulin analog (BIAsp 30) as treatment advancement in type 2 diabetes suboptimally controlled on basal insulin plus oral antihyperglycemic drugs (OADs). Research Design and Methods: SoliMix, a 26-week, open-label, multicenter study, randomized adults with suboptimally controlled basal insulin-treated type 2 diabetes (HbA1c ≥7.5 % and ≤10 %) to once-daily iGlarLixi or twice-daily BIAsp 30. Primary efficacy endpoints were non-inferiority in HbA1c reduction (margin 0.3 %) or superiority in bodyweight change for iGlarLixi versus BIAsp 30. Results: Both primary efficacy endpoints were met: after 26 weeks, baseline HbA1c (8.6 %) was reduced by 1.3 % with iGlarLixi and 1.1 % with BIAsp 30, meeting non-inferiority (least squares [LS] mean difference [97.5% CI]: -0.2 [-0.4, -0.1] %; p<0.001). iGlarLixi was also superior to BIAsp 30 for bodyweight change (LS mean difference [95% CI] -1.9 [-2.3, -1.4] kg) and percentage of participants achieving HbA1c <7 % without weight gain and HbA1c <7 % without weight gain and without hypoglycemia (all p<0.001). iGlarLixi was also superior versus BIAsp 30 for HbA1c reduction (p<0.001). Incidence and rates of ADA 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.

KW - Premix insulin

KW - basal insulins

KW - Type 2

KW - glycemic control

KW - GLP-1 agonist

KW - hypoglycemia

KW - bodyweight

KW - therapy

KW - therapy intensification

KW - GLP-1 RA

KW - fixed-ratio combination

UR - https://www.scopus.com/pages/publications/85114762701

U2 - 10.2337/dc21-0393

DO - 10.2337/dc21-0393

M3 - Article

C2 - 34183429

AN - SCOPUS:85114762701

SN - 0149-5992

VL - 44

SP - 2361

EP - 2370

JO - Diabetes Care

JF - Diabetes Care

IS - 10

ER -