Comparison of Pharmacokinetics and Pharmacodynamics of Inhaled Technosphere Insulin and Subcutaneous Insulin Lispro in the Treatment of Type 1 Diabetes Mellitus.

ABSTRACT:

Background

This study was performed to satisfy a US Food and Drug Administration post-marketing requirement to compare the dose responses for Technosphere^® Insulin (TI; MannKind Corporation, Westlake Village, CA, USA) and subcutaneous insulin lispro (LIS) across a wide range of doses.

Objectives

This single-center, open-label, randomized, cross-over study defined the pharmacokinetic/pharmacodynamic curves for inhaled TI vs subcutaneous LIS in persons with type 1 diabetes mellitus.

Methods

Each volunteer received six treatments while undergoing euglycemic clamps: three doses of TI (10, 30 and 120 U) and LIS (8, 30, and 90 U). Primary endpoint was area under the glucose infusion rate vs time curve from start of treatment administration to end of clamp. Key se

SUBMITTER: Grant M 

PROVIDER: S-EPMC8891188 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature