Coverage of Postprandial Blood Glucose Excursions With Inhaled Technosphere Insulin in Comparison to Subcutaneously Injected Regular Human Insulin in Subjects With Type 2 Diabetes
- Klaus Rave, MD1,
- Tim Heise, MD1,
- Andreas Pfützner, MD, PHD2 and
- Anders H. Boss, MD, MFPM3
- 1Profil Institute for Metabolic Research, Neuss, Germany
- 2IKFE Institute for Clinical Research and Development, Mainz, Germany
- 3MannKind Corporation, Danbury, Connecticut
- Address correspondence and reprint requests to Klaus Rave, MD, Profil Institute for Metabolic Research, Hellersbergstr. 9, 41460 Neuss, Germany. E-mail: klaus.rave{at}profil-research.de
Technosphere Insulin (TI) is a formulation of regular human insulin (RHI) that provides efficient pulmonary administration (1) and demonstrates unique pharmacokinetic and pharmacodynamic properties compared with subcutaneous RHI, rapid-acting insulin analogs, and other inhaled insulins (2). Administration of TI results in a time to maximum insulin concentration of ∼15 min, with almost complete absorption within 3 h (3,4). With an onset of action comparable to intravenous insulin, TI represents the first formulation that approaches the physiological early insulin release. In this study, we evaluated the efficacy and safety of TI compared with subcutaneous RHI in covering prandial insulin needs. We measured blood glucose excursions after a meal challenge after individual titration of either insulin formulation during a 7-day treatment period in subjects with type 2 diabetes.
RESEARCH DESIGN AND METHODS—
This prospective, open-label, randomized, two-period, cross-over study was conducted at one center (Profil Institute for Metabolic Research, Neuss, Germany). The study included a screening visit, 24-h in-house exposure to TI to establish initial dosing, two 7-day ambulant periods of daily mealtime TI or subcutaneous RHI separated by a 2- to 7-day washout, and a final visit. In-house meal challenges, using a standardized mixed meal with 496 kcal, were conducted at the end of each ambulant period. During treatment periods, each subject inhaled TI via a MedTone Model C Inhaler (MannKind Corporation, Valencia, CA) …
