Trial reportClinical drug investigation2014
Glucose-lowering effect of insulin degludec is independent of subcutaneous injection region.
Trial report in Clinical drug investigation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01151072 (A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties of NN1250 After Different Routes of Administration in Healthy Subjects), which is not on this map. Cited by 8 papers.
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 Comparing the Pharmacokinetic and Pharmacodynamic Properties of NN1250 After Different Routes of Administration in Healthy Subjects
Who cites it
8 citing papers in PubMed, 40 citations in OpenAlex.
- Pharmacokinetic and Pharmacodynamic Characteristics of Insulin Icodec After Subcutaneous Administration in the Thigh, Abdomen or Upper Arm in Individuals with Type 2 Diabetes Mellitus.Clinical drug investigation · 2023Trial
- Comparison of Insulins Glargine and Degludec in Diabetic Rhesus Macaques (Comparative medicine · 2021Article
- Factors Affecting the Absorption of Subcutaneously Administered Insulin: Effect on Variability.Journal of diabetes research · 2018Review
- Pharmacokinetic Properties of Fast-acting Insulin Aspart Administered in Different Subcutaneous Injection Regions: Response to the commentary by Nuggehally R. Srinivas.Clinical drug investigation · 2017Article
- Pharmacodynamics of Insulin Preparations Administered in Different Subcutaneous Injection Sites: Are There Differences Between Healthy Subjects Versus Diabetic Patients?Clinical drug investigation · 2017Article
- Concentrated insulins: the new basal insulins.Therapeutics and clinical risk management · 2016Review
- A review of the pharmacological properties of insulin degludec and their clinical relevance.Clinical pharmacokinetics · 2014Review
- Review
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesPatients with diabetes mellitus inject insulin in different regions of the body. This study investigated the pharmacokinetic and pharmacodynamic properties of insulin degludec (IDeg), a new-generation once-daily basal insulin with an ultra-long duration of action, after subcutaneous (SC) administration in different injection regions.
methodsIn this study, 20 healthy subjects received single SC doses of IDeg (0.4 U/kg; separated by 13-21 days) in the thigh, abdomen and deltoid in a randomised, open-label, single-centre, single-dose, complete crossover trial. Each dose was followed by a 24-h euglycaemic clamp and 120-h pharmacokinetic blood sampling. The obtained pharmacokinetic/pharmacodynamic profiles were extrapolated to steady state by simulation using a pharmacokinetic/pharmacodynamic model.
resultsTotal IDeg exposure [area under the IDeg serum concentration-time curve 0-120 h after a single dose (AUCIDeg,0-120h,SD)] and maximum serum concentration [maximum IDeg serum concentration after a single dose (C max,IDeg,SD)] were higher (6-7 and 23-27 %, respectively) following a single SC dose in the deltoid or abdomen, compared with the thigh, as also observed with other insulin preparations. No statistical difference was observed in these measures between deltoid and abdominal administration. No pronounced differences were observed in the glucose-lowering effect of IDeg [area under the glucose infusion rate (GIR) curve 0-24 h after a single dose (AUCGIR,0-24h,SD) and maximum GIR after a single dose (GIRmax,SD)] when injected in the thigh, abdomen or deltoid (AUCGIR,0-24h,SD 2,572, 2,833 and 2,960 mg/kg, respectively). Simulated mean steady-state pharmacokinetic and pharmacodynamic profiles supported a flat and stable IDeg exposure and effect regardless of injection region, with comparable total glucose-lowering effects [area under the GIR curve at steady state (AUCGIR,τ,SS)] between the thigh, abdomen and deltoid.
conclusionsThese findings support administering IDeg SC in the thigh, upper arm or abdominal wall without affecting IDeg absorption or effect at steady state.
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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 OpenQuestion graph.