New insulin glargine 300 units · mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 units · mL-1
Abstract
Objective To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of a new insulin glargine comprising 300 units · mL(-1) (Gla-300), compared with insulin glargine 100 units · mL(-1) (Gla-100) at steady state in people with type 1 diabetes. Research design and methods A randomized, double-blind, crossover study (N = 30) was conducted, applying the euglycemic clamp technique over a period of 36 h. In this multiple-dose to steady-state study, participants received once-daily subcutaneous administrations of either 0.4 (cohort 1) or 0.6 units · kg(-1) (cohort 2) Gla-300 for 8 days in one treatment period and 0.4 units · kg(-1) Gla-100 for 8 days in the other. Here we focus on the results of a direct comparison between 0.4 units · kg(-1) of each treatment. PK and PD assessments performed on the last treatment day included serum insulin measurements using a radioimmunoassay and the automated euglycemic glucose clamp technique over 36 h. Results At steady state, insulin concentration (INS) and glucose infusion rate (GIR) profiles of Gla-300 were more constant and more evenly distributed over 24 h compared with those of Gla-100 and lasted longer, as supported by the later time (∼ 3 h) to 50% of the area under the serum INS and GIR time curves from time zero to 36 h post dosing. Tight blood glucose control (≤ 105 mg · dL(-1)) was maintained for approximately 5 h longer (median of 30 h) with Gla-300 compared with Gla-100. Conclusions Gla-300 provides more even steady-state…
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U-300 glargine has a longer duration of action than U-100 glargine but modestly lower efficacy per unit administered.
“U-300 glargine has a longer duration of action than U-100 glargine but modestly lower efficacy per unit administered (179-181).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [179]
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- Authors
- Becker, R. H. A., Dahmen, R., Bergmann, K., Lehmann, A., Jax, T., & Heise, T.
- Affiliations
- Sanofi (Germany) (DE)
- Profil Institute for Metabolic Research (DE)
- Corresponding author
- Becker, Reinhard H.A.
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2014-08-22
- Volume
- 38
- Issue
- 4
- Pages
- 637-643
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W1849264946
- Cited by
- 407
- References
- 1
- Citations by year
- 2026: 6 · 2025: 20 · 2024: 35 · 2023: 16 · 2022: 33 · 2021: 34 · 2020: 44 · 2019: 45 · 2018: 54 · 2017: 46 · 2016: 44 · 2015: 24 · 2014: 4 · 2012: 1
- FWCI
- 31.62
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Growth Hormone and Insulin-like Growth Factors
- Keywords
- insulin glargine, long-acting insulin, type 1 diabetes, pharmacokinetics, pharmacodynamics, duration of action, glycemic control, glucose infusion rate, euglycemic clamp
- MeSH terms
- Insulin Glargine, Adolescent, Adult, Aged, Blood Glucose, Diabetes Mellitus, Type 1, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Hypoglycemic Agents, Male, Middle Aged, Time Factors, Cross-Over Studies, Insulin, Long-Acting, Young Adult
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