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(14) ULTRA-RAPID PROFILE OF INSULIN HUMAN INHALATION POWDER MIMICS TIME-ACTION PROFILE OF PHYSIOLOGIC ABSORPTION OF GLUCOSE FROM MIXED-MEAL TOLERANCE TESTS IN TYPE 2 DIABETES


Authors:

David Kendall, MD – Chief Medical Officer, MannKind Corporation, Westlake Village, CA

Marshall Grant, PhD, MSc – Senior Director, Clinical Pharmacology, MannKind Corporation, Westlake Village, CA

Rich Bergenstal, MD – Executive Director, International Diabetes Center, Park Nicollet, Minneapolis, MN

Anne Peters, MD – Director, USC Clinical Diabetes Programs, Keck School of Medicine, University of Southern California, Los Angeles, CA

Frank Pompilio, PharmD – Vice President, Medical Affairs, MannKind Corporation, Westlake Village, CA

Simon Bruce, MD – Clinical Development, Kinexum Services LLC, San Diego, CA

Abstract:

Objective :

To compare the metabolic responses to 2 insulins demonstrating distinctly different pharmacokinetic profiles, Technosphere® Insulin (TI) inhalation powder and subcutaneous insulin lispro (LIS). TI inhalation powder undergoes ultra-rapid absorption with a correspondingly fast onset and quick rise to peak action with a short duration of effect. LIS is absorbed more slowly with a longer time to peak action and longer duration of glucose-lowering effect.

Methods : Twelve patients with type 2 diabetes underwent 2 mixed-meal tolerance tests after receiving LIS 10 U (n=12) or TI 16 or 24 units (n=6 per dose) in random order in a cross-over design. Endogenous glucose production (EGP) rate and glucose absorption (Ra) and disposal rates (Rd) were derived from tracer data.

Results :

With TI, the maximum Rd and maximum EGP suppression occurred 30 to 45 minutes after the start of the meal and coincided with the maximum Ra from the meal. With LIS, pharmacodynamic effects peaked after the maximum Ra.

Discussion :

The mean PPG curves for the 3 treatments demonstrated that TI achieves nearly constant glucose concentrations for 90 minutes after the start of the meal, while PPG significantly rises within the first 30 minutes after administration of LIS. The mean PPG excursion of the group receiving TI 24 units did not exceed 10 mg/dL during the first 90 minutes. In contrast, the PPG excursion after LIS 10 U required less than 20 minutes to reach 10 mg/dL. A dose of TI 16 units controlled PPG excursions below 10 mg/dL for more than 45 minutes. Differences from the LIS-PPG curve were statistically significant from 30 to 60 minutes at the low dose of TI and from 45 to 105 minutes at the higher dose of TI. The tight control of early PPG results from the agreement in timing of TI’s insulin-induced glucose demand and glucose absorption from a mixed meal. The duration of PPG control is dose dependent. Consistent with its short duration of effect, PPG started to rise approximately 120 minutes after dosing, but TI’s rapid clearance suggests a small supplemental dose may be taken at that time to extend control with little risk of late postprandial hypoglycemia.

Conclusion : These studies confirm that TI, with its well-timed, insulin-mediated glucose disposal and suppression of EGP, can handle early absorption of glucose during mixed meals.

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