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Related Experiment Video

Updated: Mar 1, 2026

Dry Powder and Nebulized Aerosol Inhalation of Pharmaceuticals Delivered to Mice Using a Nose-only Exposure System

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A Population Dose-Response Model for Inhaled Technosphere Insulin Administered to Healthy Subjects.

D Rüppel¹, R Dahmen¹, A Boss²

¹Sanofi-Aventis Deutschland GmbH, R&D Frankfurt, Germany.

CPT: Pharmacometrics & Systems Pharmacology

|June 2, 2017

Summary

Technosphere insulin (TI), an inhaled rapid-acting insulin, was compared to regular human insulin (RHI). A pharmacokinetic-GIR model estimated TI requires a 5-fold higher dose than RHI for equivalent glucose control.

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Area of Science:

Pharmacology
Endocrinology
Pharmacokinetics

Background:

Technosphere insulin (TI) offers a novel approach to prandial glucose control due to its rapid onset.
Comparing TI efficacy to traditional insulins is crucial for clinical application.

Purpose of the Study:

To compare the glucose-lowering effects of TI and regular human insulin (RHI) in healthy volunteers.
To develop a pharmacokinetic-GIR model to establish a dose-response relationship for TI and RHI.

Main Methods:

A euglycemic glucose clamp study was conducted in healthy volunteers.
A pharmacokinetic-GIR model was developed to simulate glucose infusion rate (GIR) over 20 hours.
Dose-response models were generated from simulated GIR profiles.

Main Results:

Direct clinical data did not allow for a complete dose-response relationship due to limited recording time and tested doses.
The developed model simulated GIR for extended periods and higher doses.
The model indicated an ED50 for TI that is 5-fold higher than for RHI.

Conclusions:

A 5-fold higher dose of TI compared to RHI is estimated for equivalent glucose-lowering effect.
This ratio can serve as a conversion factor for determining equivalent insulin doses.
The pharmacokinetic-GIR model successfully simulated dose-response relationships for inhaled insulin therapy.