Advancing therapy with iGlarLixi versus premix BIAsp 30 in basal insulin-treated type 2 diabetes: Design and baseline characteristics of the SoliMix randomized controlled trial.
GLP-1 analogue
basal insulin
glycaemic control
insulin therapy
randomized trial
type 2 diabetes
Journal
Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645
Informations de publication
Date de publication:
06 2021
06 2021
Historique:
revised:
01
02
2021
received:
30
11
2020
accepted:
15
02
2021
pubmed:
20
2
2021
medline:
10
7
2021
entrez:
19
2
2021
Statut:
ppublish
Résumé
Premix insulin is commonly used in some regions of the world, despite the higher risk of hypoglycaemia and weight gain compared with basal insulin, based on the premise that it offers a simplified insulin regimen. iGlarLixi is a once-daily titratable fixed-ratio formulation that combines basal insulin glargine 100 units/mL (iGlar) and the GLP-1 RA, lixisenatide, which offers a single-injection option for treatment intensification, with improved HbA1c reductions, similar hypoglycaemia risk and more favourable bodyweight profiles over iGlar alone. This randomized controlled study directly compares, for the first time, treatment intensification with iGlarLixi versus premix insulin analogue biphasic insulin aspart 30 (BIAsp 30) in adults with T2D inadequately controlled on basal insulin in combination with one or two oral antihyperglycaemic drugs. This was an open-label, active-controlled, comparative, parallel-group, multicentre, phase 3b study. In total, 887 adults with T2D uncontrolled on basal insulin were randomized to switch to either iGlarLixi once daily, or BIAsp 30 twice daily, for 26 weeks. Overall, 887 participants were enrolled (mean age 59.8 years, 50.2% female) from 89 centres in 17 countries. At baseline, 65.6% had a duration of T2D of 10 years or longer, and the mean HbA1c at baseline was 8.6%. The study directly compared the efficacy and safety of iGlarLixi versus BIAsp 30 in people with T2D uncontrolled on basal insulin and one or more oral antihyperglycaemic agents. These results provide robust clinical data that may inform clinicians in their therapeutic management of people with T2D uncontrolled on basal insulin requiring additional therapy.
Substances chimiques
Biphasic Insulins
0
Blood Glucose
0
Drug Combinations
0
Glycated Hemoglobin A
0
Hypoglycemic Agents
0
insulin aspart, insulin aspart protamine drug combination 30:70
0
Insulin Glargine
2ZM8CX04RZ
Insulin, Isophane
53027-39-7
Insulin Aspart
D933668QVX
Types de publication
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1221-1231Subventions
Organisme : Sponsorship for this study was funded by Sanofi, Paris, France
Commentaires et corrections
Type : ErratumIn
Informations de copyright
© 2021 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
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