Improved patient-reported outcomes with iGlarLixi versus premix BIAsp 30 in people with type 2 diabetes in the SoliMix trial

William H. Polonsky; Francesco Giorgino; Julio Rosenstock; Katherine Whitmire; Elisheva Lew; Mathieu Coudert; Agustina Alvarez; Charlie Nicholls; Rory J. McCrimmon

doi:10.1111/dom.14822

Improved patient-reported outcomes with iGlarLixi versus premix BIAsp 30 in people with type 2 diabetes in the SoliMix trial

William H. Polonsky (Lead / Corresponding author)
, Francesco Giorgino
, Julio Rosenstock
, Katherine Whitmire
, Elisheva Lew
, Mathieu Coudert
, Agustina Alvarez
, Charlie Nicholls
, Rory J. McCrimmon

Research output: Contribution to journal › Article › peer-review

16 Citations (Scopus)

308 Downloads (Pure)

Abstract

Aim: To assess patient-reported outcomes (PROs) in the SoliMix trial, which compared the efficacy and safety of iGlarLixi versus BIAsp 30 in people with type 2 diabetes (T2D).

Materials and Methods: SoliMix (EudraCT: 2017-003370-13), a 26-week, open-label study, randomized (1:1) 887 adults with T2D and HbA1c ≥7.5%-≤10.0% (≥58-≤86 mmol/mol) on basal insulin plus oral antihyperglycaemic drugs (OADs) to once-daily iGlarLixi or twice-daily premix insulin, BIAsp 30. PROs were assessed using the Treatment-Related Impact Measure Diabetes (TRIM-D) and Global Treatment Effectiveness Evaluation (GTEE) questionnaires.

Results: Over 26 weeks, iGlarLixi showed greater improvement from baseline versus BIAsp 30 in total TRIM-D score (least squares mean difference [95% confidence interval]: 5.08 [3.69, 6.47]; effect size: 0.32) and in each TRIM-D domain, with the greatest differences seen in diabetes management (8.47 [6.11, 10.84]) and treatment burden (6.95 [4.83, 9.07]). GTEE scores showed a greater proportion of participants and physicians rated a complete or marked improvement of diabetes control with iGlarLixi (80.5%, 82.8%) versus BIAsp 30 (63.3%, 65.1%) at week 26. Post hoc analyses showed that after adjusting for HbA1c, body weight and hypoglycaemia outcomes, iGlarLixi continued to show greater improvements in TRIM-D total scores versus BIAsp 30.

Conclusions: In addition to better glycaemic control, weight benefit and less hypoglycaemia, once-daily iGlarLixi provided improved diabetes management, treatment burden and perceived effectiveness versus twice-daily premix BIAsp 30, further supporting iGlarLixi as an advanced treatment option in people with suboptimally controlled T2D on basal insulin plus OADs.

Original language	English
Pages (from-to)	2364-2372
Number of pages	9
Journal	Diabetes, Obesity and Metabolism
Volume	24
Issue number	12
Early online date	23 Aug 2022
DOIs	https://doi.org/10.1111/dom.14822
Publication status	Published - Dec 2022

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

basal insulin
GLP-1 analogue
glycaemic control
iGlarLixi
patient-reported outcomes
type 2 diabetes

ASJC Scopus subject areas

Endocrinology
Internal Medicine
Endocrinology, Diabetes and Metabolism

Access to Document

10.1111/dom.14822Licence: CC BY-NC

Final Published VersionFinal published version, 1.23 MBLicence: CC BY-NC

Cite this

@article{3e28bae5142b4d02b565e17271fba0d5,

title = "Improved patient-reported outcomes with iGlarLixi versus premix BIAsp 30 in people with type 2 diabetes in the SoliMix trial",

abstract = "Aim: To assess patient-reported outcomes (PROs) in the SoliMix trial, which compared the efficacy and safety of iGlarLixi versus BIAsp 30 in people with type 2 diabetes (T2D). Materials and Methods: SoliMix (EudraCT: 2017-003370-13), a 26-week, open-label study, randomized (1:1) 887 adults with T2D and HbA1c ≥7.5\%-≤10.0\% (≥58-≤86 mmol/mol) on basal insulin plus oral antihyperglycaemic drugs (OADs) to once-daily iGlarLixi or twice-daily premix insulin, BIAsp 30. PROs were assessed using the Treatment-Related Impact Measure Diabetes (TRIM-D) and Global Treatment Effectiveness Evaluation (GTEE) questionnaires. Results: Over 26 weeks, iGlarLixi showed greater improvement from baseline versus BIAsp 30 in total TRIM-D score (least squares mean difference [95\% confidence interval]: 5.08 [3.69, 6.47]; effect size: 0.32) and in each TRIM-D domain, with the greatest differences seen in diabetes management (8.47 [6.11, 10.84]) and treatment burden (6.95 [4.83, 9.07]). GTEE scores showed a greater proportion of participants and physicians rated a complete or marked improvement of diabetes control with iGlarLixi (80.5\%, 82.8\%) versus BIAsp 30 (63.3\%, 65.1\%) at week 26. Post hoc analyses showed that after adjusting for HbA1c, body weight and hypoglycaemia outcomes, iGlarLixi continued to show greater improvements in TRIM-D total scores versus BIAsp 30. Conclusions: In addition to better glycaemic control, weight benefit and less hypoglycaemia, once-daily iGlarLixi provided improved diabetes management, treatment burden and perceived effectiveness versus twice-daily premix BIAsp 30, further supporting iGlarLixi as an advanced treatment option in people with suboptimally controlled T2D on basal insulin plus OADs.",

keywords = "basal insulin, GLP-1 analogue, glycaemic control, iGlarLixi, patient-reported outcomes, type 2 diabetes",

author = "Polonsky, \{William H.\} and Francesco Giorgino and Julio Rosenstock and Katherine Whitmire and Elisheva Lew and Mathieu Coudert and Agustina Alvarez and Charlie Nicholls and McCrimmon, \{Rory J.\}",

note = "Funding Information: Sanofi Copyright Information: {\textcopyright} 2022 The Authors. Diabetes, Obesity and Metabolism published by John Wiley \& Sons Ltd.",

year = "2022",

month = dec,

doi = "10.1111/dom.14822",

language = "English",

volume = "24",

pages = "2364--2372",

journal = "Diabetes, Obesity and Metabolism",

issn = "1462-8902",

publisher = "Wiley",

number = "12",

}

Improved patient-reported outcomes with iGlarLixi versus premix BIAsp 30 in people with type 2 diabetes in the SoliMix trial. / Polonsky, William H. (Lead / Corresponding author); Giorgino, Francesco; Rosenstock, Julio et al.
In: Diabetes, Obesity and Metabolism, Vol. 24, No. 12, 12.2022, p. 2364-2372.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Improved patient-reported outcomes with iGlarLixi versus premix BIAsp 30 in people with type 2 diabetes in the SoliMix trial

AU - Polonsky, William H.

AU - Giorgino, Francesco

AU - Rosenstock, Julio

AU - Whitmire, Katherine

AU - Lew, Elisheva

AU - Coudert, Mathieu

AU - Alvarez, Agustina

AU - Nicholls, Charlie

AU - McCrimmon, Rory J.

PY - 2022/12

Y1 - 2022/12

N2 - Aim: To assess patient-reported outcomes (PROs) in the SoliMix trial, which compared the efficacy and safety of iGlarLixi versus BIAsp 30 in people with type 2 diabetes (T2D). Materials and Methods: SoliMix (EudraCT: 2017-003370-13), a 26-week, open-label study, randomized (1:1) 887 adults with T2D and HbA1c ≥7.5%-≤10.0% (≥58-≤86 mmol/mol) on basal insulin plus oral antihyperglycaemic drugs (OADs) to once-daily iGlarLixi or twice-daily premix insulin, BIAsp 30. PROs were assessed using the Treatment-Related Impact Measure Diabetes (TRIM-D) and Global Treatment Effectiveness Evaluation (GTEE) questionnaires. Results: Over 26 weeks, iGlarLixi showed greater improvement from baseline versus BIAsp 30 in total TRIM-D score (least squares mean difference [95% confidence interval]: 5.08 [3.69, 6.47]; effect size: 0.32) and in each TRIM-D domain, with the greatest differences seen in diabetes management (8.47 [6.11, 10.84]) and treatment burden (6.95 [4.83, 9.07]). GTEE scores showed a greater proportion of participants and physicians rated a complete or marked improvement of diabetes control with iGlarLixi (80.5%, 82.8%) versus BIAsp 30 (63.3%, 65.1%) at week 26. Post hoc analyses showed that after adjusting for HbA1c, body weight and hypoglycaemia outcomes, iGlarLixi continued to show greater improvements in TRIM-D total scores versus BIAsp 30. Conclusions: In addition to better glycaemic control, weight benefit and less hypoglycaemia, once-daily iGlarLixi provided improved diabetes management, treatment burden and perceived effectiveness versus twice-daily premix BIAsp 30, further supporting iGlarLixi as an advanced treatment option in people with suboptimally controlled T2D on basal insulin plus OADs.

AB - Aim: To assess patient-reported outcomes (PROs) in the SoliMix trial, which compared the efficacy and safety of iGlarLixi versus BIAsp 30 in people with type 2 diabetes (T2D). Materials and Methods: SoliMix (EudraCT: 2017-003370-13), a 26-week, open-label study, randomized (1:1) 887 adults with T2D and HbA1c ≥7.5%-≤10.0% (≥58-≤86 mmol/mol) on basal insulin plus oral antihyperglycaemic drugs (OADs) to once-daily iGlarLixi or twice-daily premix insulin, BIAsp 30. PROs were assessed using the Treatment-Related Impact Measure Diabetes (TRIM-D) and Global Treatment Effectiveness Evaluation (GTEE) questionnaires. Results: Over 26 weeks, iGlarLixi showed greater improvement from baseline versus BIAsp 30 in total TRIM-D score (least squares mean difference [95% confidence interval]: 5.08 [3.69, 6.47]; effect size: 0.32) and in each TRIM-D domain, with the greatest differences seen in diabetes management (8.47 [6.11, 10.84]) and treatment burden (6.95 [4.83, 9.07]). GTEE scores showed a greater proportion of participants and physicians rated a complete or marked improvement of diabetes control with iGlarLixi (80.5%, 82.8%) versus BIAsp 30 (63.3%, 65.1%) at week 26. Post hoc analyses showed that after adjusting for HbA1c, body weight and hypoglycaemia outcomes, iGlarLixi continued to show greater improvements in TRIM-D total scores versus BIAsp 30. Conclusions: In addition to better glycaemic control, weight benefit and less hypoglycaemia, once-daily iGlarLixi provided improved diabetes management, treatment burden and perceived effectiveness versus twice-daily premix BIAsp 30, further supporting iGlarLixi as an advanced treatment option in people with suboptimally controlled T2D on basal insulin plus OADs.

KW - basal insulin

KW - GLP-1 analogue

KW - glycaemic control

KW - iGlarLixi

KW - patient-reported outcomes

KW - type 2 diabetes

UR - https://www.scopus.com/pages/publications/85136897014

U2 - 10.1111/dom.14822

DO - 10.1111/dom.14822

M3 - Article

C2 - 36053820

SN - 1462-8902

VL - 24

SP - 2364

EP - 2372

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

IS - 12

ER -

Improved patient-reported outcomes with iGlarLixi versus premix BIAsp 30 in people with type 2 diabetes in the SoliMix trial

Abstract

UN SDGs

Keywords

ASJC Scopus subject areas

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