Objective: To confirm efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp), both with basal insulin degludec, in a pediatric population with type 1 diabetes.
Research Design And Methods: After a 12-week run-in, this treat-to-target, 26-week, multicenter trial randomized participants (1 to <18 years) to double-blind mealtime faster aspart ( = 260), mealtime IAsp ( = 258), or open-label postmeal faster aspart ( = 259). The primary end point was change from baseline in glycated hemoglobin (HbA) after 26 weeks of treatment. All available information regardless of treatment discontinuation was used for the evaluation of treatment effect.
Results: At week 26, mealtime and postmeal faster aspart were noninferior to IAsp regarding change from baseline in HbA ( < 0.001 for noninferiority [0.4% margin]), with a statistically significant difference in favor of mealtime faster aspart (estimated treatment difference -0.17% [95% CI -0.30; -0.03], -1.82 mmol/mol [-3.28; -0.36]; = 0.014). Change from baseline in 1-h postprandial glucose increment significantly favored mealtime faster aspart versus IAsp at breakfast, main evening meal, and over all meals ( < 0.01 for all). No statistically significant differences in the overall rate of severe or blood glucose-confirmed hypoglycemia were observed. Mean total daily insulin dose was 0.92 units/kg for mealtime faster aspart, 0.92 units/kg for postmeal faster aspart, and 0.88 units/kg for mealtime IAsp.
Conclusions: In children and adolescents with type 1 diabetes, mealtime and postmeal faster aspart with insulin degludec provided effective glycemic control with no additional safety risks versus IAsp. Mealtime faster aspart provided superior HbA control compared with IAsp.
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http://dx.doi.org/10.2337/dc19-0009 | DOI Listing |
Diabetes Obes Metab
December 2024
Novo Nordisk India Private Limited, Bangalore, India.
Aims: To investigate glycaemic control in Chinese adults with type 2 diabetes (T2D) initiating, or switching to insulin degludec/insulin aspart (IDegAsp), a co-formulation of basal, and bolus insulin, in a real-world setting.
Materials And Methods: A 20-week, prospective, single-arm, open-label, non-interventional study was conducted in Chinese adults with T2D initiating, or switching to IDegAsp after anti-hyperglycaemic treatment with oral antidiabetic drugs (OADs), other insulins, or glucagon-like peptide-1 receptor agonists. The primary endpoint was a change in HbA from baseline to end of the study; the secondary endpoints included a change in fasting plasma glucose and Diabetes Treatment Satisfaction Questionnaire (DTSQ) score.
Res Pharm Sci
October 2024
BioGenomics Ltd, Maharastra, India.
Background And Purpose: To compare the efficacy, safety, and immunogenicity of recombinant insulin aspart 100 U/mL manufactured by BioGenomics Limited (BGL-ASP) with innovator NovoRapid in type 2 diabetes mellitus patients (T2 DM).
Experimental Approach: This was a multicenter, open-label, randomized, parallel-group study in T2 DM patients, on premix human insulin therapy ± oral anti-diabetics. Besides self-monitored plasma glucose, fasting and post-prandial plasma glucose (FPG and PPG) were tested at baseline, week 12, and week 24.
J Diabetes Investig
December 2024
Novo Nordisk A/S, Søborg, Denmark.
Introduction: Insulin icodec is a basal insulin designed for once-weekly administration. This study assessed the pharmacological properties of icodec in Japanese individuals with type 1 diabetes (T1D).
Materials And Methods: In a randomized, open-label, crossover study, 24 Japanese individuals with T1D (20-64 years; glycated hemoglobin ≤9.
Endocr Pract
December 2024
Section of Endocrinology, Diabetes, Nutrition and Weight Management, Boston University Chobanian & Avedisian School of Medicine and Boston Medical Center. Boston MA, 02118. Electronic address:
Objective: Hyperglycemia in hospitalized patients is associated with increased morbidity and mortality. Basal-bolus insulin therapy is the treatment of choice for most patients. The efficacy of an ultrarapid vs.
View Article and Find Full Text PDFExpert Opin Pharmacother
December 2024
Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
Introduction: A stepwise coordinated multiple therapeutic targeted approach to the treatment of type 2 diabetes includes starting with lifestyle modification, oral antihyperglycemic agents, non-insulin injectables (Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), and both short and long-acting insulins. Ultra-long-acting insulins offer more convenient administration. As in any chronic disease, the introduction of a novel medication must balance safety, efficacy, financial cost, as well as improved patient convenience and adherence.
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