Trial reportDiabetes care2011
Pharmacokinetics and pharmacodynamics of high-dose human regular U-500 insulin versus human regular U-100 insulin in healthy obese subjects.
Trial report in Diabetes care, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 46 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
46 citing papers in PubMed, 1 synthesis or guideline pooled it, 121 citations in OpenAlex.
- Clinical use of U-500 regular insulin: review and meta-analysis.Journal of diabetes science and technology · 2012Pooled it
- A New Highly Concentrated Insulin Aspart AT278 (500 U/mL) Demonstrates Ultra-Rapid Pharmacokinetic and Pharmacodynamic Properties in Type 2 Diabetes Regardless of BMI.Diabetes, obesity & metabolism · 2026Trial
- Pharmacokinetics and Pharmacodynamics of a Novel U500 Insulin Aspart Formulation: A Randomized, Double-Blind, Crossover Study in People With Type 1 Diabetes.Diabetes care · 2023Trial
- Pharmacokinetics and Pharmacodynamics of Human Regular U-500 Insulin Administered via Continuous Subcutaneous Insulin Infusion Versus Subcutaneous Injection in Adults With Type 2 Diabetes and High-Dose Insulin Requirements.Journal of diabetes science and technology · 2022Trial
- Pharmacokinetic and pharmacodynamic bioequivalence between regular human insulin (rDNA origin) in 0.9% sodium chloride ready-to-use infusion 1 U/mL and 100 U/mL concentrate diluted to 1 U/mL in healthy males.Diabetes, obesity & metabolism · 2021Trial
- Human regular U-500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in adults with type 2 diabetes: The VIVID study.Diabetes, obesity & metabolism · 2020Trial
- Insulin depot absorption modeling and pharmacokinetic simulation with insulin glargine 300 U/mL .International journal of clinical pharmacology and therapeutics · 2019Trial
- Modeling Pharmacokinetic Profiles of Insulin Regimens to Enhance Understanding of Subcutaneous Insulin Regimens.Journal of clinical pharmacology · 2017Trial
- Application of PK/PD modeling and simulation to dosing regimen optimization of high-dose human regular U-500 insulin.Journal of diabetes science and technology · 2014Trial
- Off-label Use of U-500 Regular Insulin with a Tubeless Automated Insulin Delivery System in Type 1 Diabetes and Severe Insulin Resistance: A Case Report.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026Article
- 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2026.Diabetes care · 2026Review
- Real-World Safety and Effectiveness of U200 Insulin Use in Automated Insulin Delivery Systems in Adolescents and Young Adults with Type 1 Diabetes.Diabetes technology & therapeutics · 2025Article
- Impact of setting distinct target blood glucose levels on endogenous insulin suppression and pharmacodynamics of insulin preparations.World journal of diabetes · 2025Article
- Practical considerations for using concentrated U200 insulin in automated insulin delivery systems.Frontiers in endocrinology · 2025Article
- 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2025.Diabetes care · 2025 · on this mapReview
- Prandial Insulins: A Person-Centered Choice.Current diabetes reports · 2024Review
- 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2024.Diabetes care · 2024Review
- One hundred years of insulin therapy.Nature reviews. Endocrinology · 2021Review
- Pharmacological inhibition of tumor anabolism and host catabolism as a cancer therapy.Scientific reports · 2021Article
- Clinical Impact of Initiation of U-500 Insulin vs Continuation of U-100 Insulin in Subjects With Diabetes.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2021Article
Corrections and comments
- Erratum issued
Authors and funding
11 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveHuman regular U-500 (U-500R) insulin (500 units/mL) is increasingly being used clinically, yet its pharmacokinetics (PK) and pharmacodynamics (PD) have not been well studied. Therefore, we compared PK and PD of clinically relevant doses of U-500R with the same doses of human regular U-100 (U-100R) insulin (100 units/mL). RESEARCH DESIGN AND
methodsThis was a single-site, randomized, double-blind, crossover euglycemic clamp study. Single subcutaneous injections of 50- and 100-unit doses of U-500R and U-100R were administered to 24 healthy obese subjects.
resultsBoth overall insulin exposure (area under the serum insulin concentration versus time curve from zero to return to baseline [AUC(0-)(t)(')]) and overall effect (total glucose infused during a clamp) were similar between formulations at both 50- and 100-unit doses (90% [CI] of ratios contained within [0.80, 1.25]). However, peak concentration and effect were significantly lower for U-500R at both doses (P < 0.05). Both formulations produced relatively long durations of action (18.3 to 21.5 h). Time-to-peak concentration and time to maximum effect were significantly longer for U-500R than U-100R at the 100-unit dose (P < 0.05). Time variables reflective of duration of action (late tR(max50), tR(last)) were prolonged for U-500R versus U-100R at both doses (P < 0.05).
conclusionsOverall exposure to and action of U-500R insulin after subcutaneous injection were no different from those of U-100R insulin. For U-500R, peaks of concentration and action profiles were blunted and the effect after the peak was prolonged. These findings may help guide therapy with U-500R insulin for highly insulin-resistant patients with diabetes.
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.