Trial reportClinical drug investigation2024
Pharmacokinetic Properties of a Once-Weekly Fixed-Ratio Combination of Insulin Icodec and Semaglutide Compared with Separate Administration of Each Component in Individuals with Type 2 Diabetes Mellitus.
Trial report in Clinical drug investigation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03789578. Cited by 8 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Trial to Investigate Single Dose Pharmacokinetics of NNC0148-0287sema in a Fixed Ratio Compared With Insulin 287 and Semaglutide Given Separately in Subjects With Type 2 Diabetes
Open the trial in the graphWho cites it
8 citing papers in PubMed.
- Efficacy and Safety of Once-Weekly IcoSema Versus Once-Daily IDegLira in People with Type 2 Diabetes: Systematic Literature Review and Network Meta-analysis.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026Article
- Glycemic efficacy of insulin icodec and risk factors for hypoglycemia in patients with type 2 diabetes mellitus: a real-world study.Frontiers in physiology · 2026Article
- Semaglutide - properties, action and chromatographic analysis.Journal of diabetes and metabolic disorders · 2025Review
- Pharmacokinetic Characteristics of a Once-Weekly Combination Therapy of Insulin Icodec and Semaglutide Versus Its Separate Components in Chinese Individuals with Type 2 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025Article
- An overview of randomized clinical trials of fixed-ratio combinations of basal insulin plus GLP-1RA (injectable therapy): Lessons for advancing therapy in people with type 2 diabetes.Diabetes, obesity & metabolism · 2025Review
- Practical limitations of complex insulin therapies in type 2 diabetes: Focus on therapy simplification using fixed-ratio combinations of basal insulin and a glucagon-like peptide-1 receptor agonist.Diabetes, obesity & metabolism · 2025Review
- Fixed-ratio combination of GLP-1 receptor agonist and basal insulin: simplifying type 2 diabetes treatment.Endocrine · 2025Article
- Efficacy and Safety of Once-Weekly IcoSema in Adults With Type 2 Diabetes: A Systematic Review and Meta-Analysis.AACE endocrinology and diabetesArticle
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveIcoSema is being developed as a subcutaneous once-weekly fixed-ratio combination of the once-weekly basal insulin icodec and the once-weekly glucagon-like peptide-1 receptor agonist semaglutide. This study investigated the pharmacokinetics of icodec and semaglutide in IcoSema versus separate administration of each component in individuals with type 2 diabetes mellitus (T2DM).
methodsIn a randomised, double-blind, three-period crossover study, 31 individuals with T2DM (18-64 years, body weight 80-120 kg, glycosylated haemoglobin 6.0-8.5%) received single subcutaneous injections of IcoSema (175 U icodec, 0.5 mg semaglutide), icodec (175 U) or semaglutide (0.5 mg) with 6-9 weeks' washout. Pharmacokinetic blood samples were drawn up to 840 h post-dose.
resultsIcodec pharmacokinetics were unaffected by combining icodec with semaglutide. The 90% confidence interval (CI) of IcoSema/icodec was within 0.80-1.25 for total exposure (area under the curve from zero to last quantifiable observation; AUC
conclusionThe combination of icodec and semaglutide in IcoSema leads to a higher and earlier maximum semaglutide concentration, which will guide the dose recommendations for IcoSema. CLINICAL TRIAL: ClinicalTrials.gov identifier: NCT03789578.
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