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


Journal

Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645

Informations de publication

Date de publication:
12 2022
Historique:
revised: 11 07 2022
received: 26 04 2022
accepted: 19 07 2022
pubmed: 3 9 2022
medline: 1 11 2022
entrez: 2 9 2022
Statut: ppublish

Résumé

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). 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. 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. 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.

Identifiants

pubmed: 36053820
doi: 10.1111/dom.14822
pmc: PMC9805099
doi:

Substances chimiques

insulin aspart, insulin aspart protamine drug combination 30:70 0
Glycated Hemoglobin A 0
Blood Glucose 0
Biphasic Insulins 0
Insulin Aspart D933668QVX
Hypoglycemic Agents 0
Insulin Glargine 2ZM8CX04RZ

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2364-2372

Informations de copyright

© 2022 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

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Auteurs

William H Polonsky (WH)

Behavioral Diabetes Institute, San Diego, California.

Francesco Giorgino (F)

Department of Emergency and Organ Transplantation, Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, University of Bari Aldo Moro, Bari, Italy.

Julio Rosenstock (J)

Dallas Diabetes Research Center at Medical City, Dallas, Texas.

Katherine Whitmire (K)

Southwest Medical Associates, Las Vegas, Nevada.

Elisheva Lew (E)

Sanofi, Chilly-Mazarin, France.

Mathieu Coudert (M)

Biostatistics and Programming Department, Sanofi, Chilly-Mazarin, France.

Agustina Alvarez (A)

Sanofi, Buenos Aires, Argentina.

Rory J McCrimmon (RJ)

Division of Systems Medicine, School of Medicine, University of Dundee, Dundee, UK.

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Classifications MeSH