@article{45c532791fa44620b79031de5eef89ce,
title = "Improvement in Patient-Reported Outcomes in Adults with Type 1 Diabetes Treated with Sotagliflozin plus Insulin Versus Insulin Alone",
abstract = "Background: Diabetes-related distress is common among persons affected by diabetes and is associated with suboptimal glycemic control and complications, thus constituting a relevant patient-report outcome (PRO). Improving glycemic control may reduce diabetes distress and improve treatment satisfaction. This post hoc analysis evaluated PRO data for a pooled cohort of adults with type 1 diabetes (T1D) receiving sotagliflozin as adjunct to optimized insulin in the inTandem1 and inTandem2 studies. Methods: Clinically meaningful changes in the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and the two-item Diabetes Distress Scale (DDS2) total and individual scores were examined in the pooled data from the first 24 weeks of the studies. Results: In the cohort of patients with a baseline DTSQs total score ?32 (?76% of entire cohort), nearly twice as many patients treated with sotagliflozin 200 (45.9%) or 400 mg (42.3%) experienced a >3-point improvement from baseline versus those treated with placebo (24%). Treatment with sotagliflozin led to statistically significant (P < 0.05) improvements across all DTSQs items. Approximately 42% of all patients were considered to have a high risk of diabetes distress (total DDS2 score ?6) at baseline following insulin optimization. More patients shifted from high to low risk with sotagliflozin compared with placebo (?40% vs. 23%; P ? 0.0002). The baseline-Adjusted difference in DDS2 from placebo was significantly (P < 0.001) reduced by-0.5 and-0.6 for sotagliflozin 200 and 400 mg, respectively. Conclusions: Patients with T1D treated with sotagliflozin in addition to optimized insulin therapy reported meaningful improvements in treatment satisfaction and diabetes distress. NCT02384941 and NCT02421510",
keywords = "Diabetes Distress Scale, Diabetes Treatment Satisfaction Questionnaire status version, Patient-reported outcomes, Sotagliflozin, Type 1 diabetes",
author = "Thomas Danne and Joish, {Vijay N.} and Marion Afonso and Phillip Banks and Sangeeta Sawhney and Pablo Lapuerta and Davies, {Michael J.} and Buse, {John B.} and Dee Lin and Matthew Reaney and Sophie Guillonneau and Snoek, {Frank J.} and Bailey, {Timothy S.} and Polonsky, {William H.}",
note = "Funding Information: V.N.J., P.L., M.J.D., P.B., and S.S. are employees of Lexicon Pharmaceuticals, Inc; authors who are employees of Lexicon Pharmaceuticals, Inc., may own common stock or may have been granted stock options or other equity incentive awards. D.L. was a postdoctoral fellow at Sanofi US, Inc., during the study and now is employed at Janssen Scientific Affairs, LLC. M.A., M.R., and S.G. are employees at Sanofi; authors who are employees of Sanofi may own common stock or may have been granted stock options or other equity incentive awards. T.S.B. has received research support from Abbott, Capillary Biomedical, Dexcom, Dia-some, Eli Lilly, Kowa, Lexicon, Medtronic, Medtrum, Novo Nordisk, REMD, Sanofi, Senseonics, ViaCyte, vTv Therapeutics, and Zealand Pharma; has received consulting honoraria from Abbott, LifeScan, Novo Nordisk, and Sanofi; and received speaking honoraria from Medtronic and Sanofi. J.B.B received contracted consulting fees paid to the University of North Carolina by Adocia, AstraZeneca, Dance Biopharm, Dexcom, Eli Lilly, Fractyl, GI Dynamics, Intarcia Therapeutics, Lexicon, MannKind, Metavention, NovaTarg, Novo Nordisk, Orexigen, PhaseBio, Sanofi, Senseonics, vTv Therapeutics, and Zafgen for 3 years, and by Adocia, As- traZeneca, Dance Biopharm, Eli Lilly, MannKind, Nova-Targ, Novo Nordisk, Senseonics, vTv Therapeutics, and Zafgen for 1 year. He received grant support from As-traZeneca, Eli Lilly, Intarcia Therapeutics, Johnson & Johnson, Lexicon, Medtronic, Novo Nordisk, Sanofi, Ther-acos, Tolerion, and vTv Therapeutics for 3 years and from Novo Nordisk, Sanofi, Tolerion, and vTv Therapeutics for 1 year. He is a consultant to Cirius Therapeutics Inc., CSL Behring, Mellitus Health, Neurimmune AG, Pendulum Therapeutics, and Stability Health; holds stock/stock options in Mellitus Health, Pendulum Therapeutics, PhaseBio, and Stability Health; and has received grant support from the National Institutes of Health (UL1TR002489, U01DK098246, UC4DK108612, U54DK118612), PCORI, and ADA. T.D. is a consultant, advisory board member, steering committee member/speaker for and has received research support from Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Dexcom, Eli Lilly, Insulet, Medtronic, Novo Nordisk, and Roche; and is a shareholder of DreaMed Diabetes Ltd. F.J.S is a consultant and advisory board member for Abbott, Eli Lilly, Novo Nordisk, and Roche Diabetes Care; has received research support from Sanofi; and his contracted consulting fees and grants are paid to the Amsterdam University Medical Centers. W.H.P. is a consultant and advisory board member for Abbott, Ascensia, AstraZeneca, Dexcom, Eli Lilly, Insulet, MannKind, Novo Nordisk, Onduo, Sanofi, Roche, and Xeris. Funding Information: This study was funded by Sanofi US, Inc., and Lexicon Pharmaceuticals, Inc., The authors received writing/editorial support provided by Grace Richmond, PhD, and Patricia Fonseca, PhD, of Excerpta Medica, funded by Sanofi US, Inc. Publisher Copyright: {\textcopyright} Thomas Danne, et al., 2021; Published by Mary Ann Liebert, Inc. 2021. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",
year = "2021",
month = jan,
day = "1",
doi = "https://doi.org/10.1089/dia.2020.0068",
language = "English",
volume = "23",
pages = "70--77",
journal = "Diabetes Technology and Therapeutics",
issn = "1520-9156",
publisher = "Mary Ann Liebert Inc.",
number = "1",
}