Trial reportClinical drug investigation2013
A comparison of the steady-state pharmacokinetic and pharmacodynamic profiles of 100 and 200 U/mL formulations of ultra-long-acting insulin degludec.
Trial report in Clinical drug investigation, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01076634 (A Trial Investigating the Pharmacodynamic Properties of NN1250 in Subjects With Type 1 Diabetes), which is not on this map. Cited by 33 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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 Investigating the Pharmacodynamic Properties of NN1250 in Subjects With Type 1 Diabetes
Who cites it
33 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Frontiers in endocrinology · 2022Pooled it
- Comparative Efficacy and Safety of Ultra-Long-Acting, Long-Acting, Intermediate-Acting, and Biosimilar Insulins for Type 1 Diabetes Mellitus: a Systematic Review and Network Meta-Analysis.Journal of general internal medicine · 2021Pooled it
- Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial.Diabetologia · 2020Trial
- Insulin depot absorption modeling and pharmacokinetic simulation with insulin glargine 300 U/mL .International journal of clinical pharmacology and therapeutics · 2019Trial
- Low within- and between-day variability in exposure to new insulin glargine 300 U/ml.Diabetes, obesity & metabolism · 2015Trial
- Factors Accounting for Pharmacodynamic Variability of Basal Insulin Preparations in Euglycemic Clamp Settings in Healthy Individuals.Clinical pharmacokinetics · 2026Article
- 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2026.Diabetes care · 2026Review
- 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2025.Diabetes care · 2025 · on this mapReview
- 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2024.Diabetes care · 2024Review
- Pharmacokinetics and bioavailability of a new long-acting insulin analog in healthy Chinese volunteers: an open, randomized, single-dose, two-period and two-sequence cross-over study.Frontiers in pharmacology · 2023Article
- Proteomic Changes to the Updated Discovery of Engineered Insulin and Its Analogs: Pros and Cons.Current issues in molecular biology · 2022Review
- One hundred years of insulin therapy.Nature reviews. Endocrinology · 2021Review
- The Evolution of Insulin Administration in Type 1 Diabetes.Journal of diabetes mellitus · 2021Article
- Considerations for Insulin-Treated Type 2 Diabetes Patients During Hospitalization: A Narrative Review of What We Need to Know in the Age of Second-Generation Basal Insulin Analogs.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020Review
- Understanding the Clinical Profile of Insulin Degludec, the Latest Basal Insulin Approved for Use in Canada: a Narrative Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020Review
- The Evolution of Insulin and How it Informs Therapy and Treatment Choices.Endocrine reviews · 2020Review
- How conclusive is the CONCLUDE trial?Diabetologia · 2020Article
- [Insulin therapy-new insulin analogues].Der Internist · 2019Review
- Pharmacologic treatment options for type 1 diabetes: what's new?Expert review of clinical pharmacology · 2019Review
- Differentiating Basal Insulin Preparations: Understanding How They Work Explains Why They Are Different.Advances in therapy · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveInsulin degludec (IDeg) is a new-generation basal insulin that forms soluble multi-hexamers upon subcutaneous injection, resulting in a depot from which IDeg monomers are slowly and continuously absorbed to provide an ultra-long action profile. This double-blind, crossover, randomized study compared the pharmacokinetic and pharmacodynamic properties between IDeg 100 U/mL (U100) and IDeg 200 U/mL (U200) under steady-state (SS) conditions in subjects with type 1 diabetes mellitus.
methodsParticipants (n = 33 adults) underwent 8-day treatment periods with 0.4 U/kg IDeg U100 and IDeg U200 given once daily with insulin aspart at mealtimes. On day 8, a 26-h euglycaemic glucose clamp (5.5 mmol/L) was performed.
resultsThe concentration-time profiles of IDeg U100 and IDeg U200 were similar, and a post-hoc analysis showed bioequivalence between these formulations, as the 90 % confidence intervals (CIs) of the U200/U100 ratios for area under the steady-state serum IDeg concentration-time curve during a dosing interval (τ; 0-24 h) (AUCτ,SS,IDeg) (0.99 [0.91-1.07]) and maximum steady-state IDeg concentration during a dosing interval (τ) (C max,SS,IDeg) (0.93 [0.84-1.02]) were within the interval 0.80-1.25. Comparable glucose infusion rates (GIR) were observed for IDeg U100 and IDeg U200 (AUCτ,SS,GIR [mg/kg]: 2,255 vs. 2,123) and the mean ratio (95 % CI) of IDeg U200/U100 for the primary endpoint (AUCτ,SS,GIR) was 0.94 [0.86-1.03]. For both formulations, the glucose-lowering effect of IDeg was evenly distributed between the first and second 12 h post-dosing (U100: AUC12,SS,GIR/AUC24,SS,GIR = 48 %; U200: AUC12,SS,GIR/AUC24,SS,GIR = 46 %). Both formulations were well tolerated, and no safety events of significance were identified.
conclusionIDeg U100 and U200 formulations are bioequivalent and have similar pharmacodynamic profiles at SS, implying that they can be used interchangeably in clinical practice.
Indexed as
Identifiers
23749405What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.