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Similar glycaemic control with less nocturnal hypoglycaemia in a 38-week trial comparing the IDegAsp co-formulation with insulin glargine U100 and insulin aspart in basal insulin-treated subjects with type 2 diabetes mellitus.
- Source :
-
Diabetes research and clinical practice [Diabetes Res Clin Pract] 2019 Jan; Vol. 147, pp. 157-165. Date of Electronic Publication: 2018 Nov 16. - Publication Year :
- 2019
-
Abstract
- Aims: To confirm non-inferiority of insulin degludec/insulin aspart (IDegAsp) once-daily (OD) versus insulin glargine (IGlar) U100 OD + insulin aspart (IAsp) OD for HbA <subscript>1c</subscript> after 26 weeks, and compare efficacy and safety between groups at W26 + W38.<br />Methods: A 38-week, randomised, open-label, treat-to-target (HbA <subscript>1c</subscript> < 7.0%) trial in adults with type 2 diabetes mellitus (on basal insulin ± oral antidiabetic drugs; HbA <subscript>1c</subscript> 7.0-10.0%). Randomisation (1:1): IDegAsp or IGlar U100 + IAsp. Intensification to IDegAsp twice daily (BID) was permitted at W26 + W32, or with additional IAsp injections at W26 (maximum IAsp BID) or W32 (maximum IAsp three-times daily).<br />Results: For W0-W26, mean percentage-change (standard deviation) HbA <subscript>1c</subscript> was: IDegAsp, -1.1 (0.9); IGlar U100 + IAsp, -1.1 (0.8); estimated treatment difference: 0.07% (95% confidence interval [CI]: -0.06; 0.21) confirmed non-inferiority. At W26 and W38, target HbA <subscript>1c</subscript> achievement, and mean fasting and postprandial glucose were similar across groups. At W38, more subjects achieved target HbA <subscript>1c</subscript> without hypoglycaemia with IDegAsp (22.5%) than with IGlar U100 + IAsp (21.1%), with significantly fewer nocturnal episodes (W0-W38, estimated rate ratio: 0.61 [95% CI: 0.40; 0.93]). Safety profiles were similar across treatment groups throughout.<br />Conclusions: IDegAsp OD/BID are effective treatment intensification options versus multiple injection basal-bolus therapies, achieving similar glycaemic control, with significantly less nocturnal hypoglycaemia.<br /> (Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.)
- Subjects :
- Diabetes Mellitus, Type 2 pathology
Female
Humans
Hypoglycemia pathology
Hypoglycemic Agents pharmacology
Insulin Aspart pharmacology
Insulin Glargine pharmacology
Male
Middle Aged
Diabetes Mellitus, Type 2 drug therapy
Hypoglycemia etiology
Hypoglycemic Agents therapeutic use
Insulin Aspart therapeutic use
Insulin Glargine therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1872-8227
- Volume :
- 147
- Database :
- MEDLINE
- Journal :
- Diabetes research and clinical practice
- Publication Type :
- Academic Journal
- Accession number :
- 30448451
- Full Text :
- https://doi.org/10.1016/j.diabres.2018.10.024