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Randomized Controlled Trial
. 2015 Jul;9(4):824-30.
doi: 10.1177/1932296815573865. Epub 2015 Feb 19.

Subcutaneous Injection Depth Does Not Affect the Pharmacokinetics or Glucodynamics of Insulin Lispro in Normal Weight or Healthy Obese Subjects

Amparo de la Peña  1 , Kwee P Yeo  2 , Helle Linnebjerg  3 , Edward Catton  3 , Shobha Reddy  3 , Patricia Brown-Augsburger  3 , Linda Morrow  4 , Debra A Ignaut  3
Affiliations
Randomized Controlled Trial

Subcutaneous Injection Depth Does Not Affect the Pharmacokinetics or Glucodynamics of Insulin Lispro in Normal Weight or Healthy Obese Subjects

Amparo de la Peña et al. J Diabetes Sci Technol. 2015 Jul.

Abstract

Background: An 8-mm needle length is commonly used for insulin injections; however, recent recommendations suggest shorter needles may help patients avoid intramuscular injections and reduce pain, while maintaining adequate glucose control. The goal of these analyses was to compare the pharmacokinetics (PK) and glucodynamics (GD) of insulin lispro after a 5-mm or an 8-mm injection depth administration in 2 populations: normal weight (study 1) or obese (study 2).

Methods: In both open-label, randomized, 2-period crossover euglycemic clamp studies, subjects received single 0.25 U/kg insulin lispro doses on 2 occasions (at 5-mm and 8-mm injection depths); samples for PK and GD analyses were collected up to 6 hours postdose. Noncompartmental PK parameters AUC0-tlast, AUC0-∞, Cmax and GD parameters Gtot, Rmax, tRmax were log-transformed prior to analysis using a mixed effects model.

Results: There were no apparent differences between PK profiles at the 5-mm or 8-mm injection depth in either study, demonstrated by the ratios of geometric means of AUC0-tlast, AUC0-∞, and Cmax being close to 1, with 90% confidence intervals (CI) within (0.80, 1.25). There were no apparent differences between GD profiles at either injection depth with the ratios of Gtot and Rmax near unity and 90% CIs that included 1. In both studies, the tRmax values were similar between injection depths, with a small median of pairwise differences and a 90% CI that included zero.

Conclusions: Injection depths in the 5-8 mm range did not affect the PK or GD of insulin lispro in normal weight or obese subjects.

Keywords: glucodynamics; injection depth; insulin lispro; pharmacokinetics.

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Conflict of interest statement

Declaration of Conflicting Interests: All authors, except Dr. Linda Morrow, are employees and minor shareholders of Eli Lilly and Company

Figures

Figure 1.
Figure 1.
Mean (± SD) serum immunoreactive insulin (IRI) concentration versus time profiles in normal weight subjects (A) and obese subjects (B), and locally weighted scatter plot smoothing (LOESS) fits of glucose infusion rate (GIR) versus time data in normal weight subjects (C) and obese subjects (D) following the administration of 0.25 U/kg insulin lispro at 5-mm and 8-mm injection depths.
See this image and copyright information in PMC

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