Comparative Study of Insulin Administration Technologies

Strategic Insights -

Researchers in Mainz, Germany conducted a comparative study on the pharmacokinetics/pharmacodynamics properties and patient preference for insulin aspart administered via the FlexPen and pulmonary human insulin delivered via the Exubera device. The study involved 12 patients with diabetes, who received 11 units of insulin from either the FlexPen or the Exubera device in a randomized sequence. The results showed no significant difference in the pharmacokinetics/pharmacodynamics parameters between the two devices within the first 120 minutes. However, in the second part of the clamp procedure, plasma insulin levels and the glucose infusion rate were significantly higher after Exubera compared to FlexPen. Despite the positive overall evaluation, most patients preferred the FlexPen device.

Key Takeaways:

  • The study compared the pharmacokinetics/pharmacodynamics properties of insulin aspart administered via the FlexPen and pulmonary human insulin delivered via the Exubera device.
  • The study involved 12 patients with diabetes, consisting of six with type 1 and six with type 2 diabetes, with a mean age of 54.5 years and a duration of diabetes of 16.5 years.
  • The patients received 11 units of insulin from either the FlexPen or the Exubera device in a randomized sequence.
  • The results showed no significant difference in the pharmacokinetics/pharmacodynamics parameters between the two devices within the first 120 minutes.
  • In the second part of the clamp procedure, plasma insulin levels and the glucose infusion rate were significantly higher after Exubera compared to FlexPen.
  • The patients' individual ratings of the handling items were assessed using a questionnaire, with most patients preferring the FlexPen device.
  • The study was conducted in an open-label, randomized, euglycemic clamp study design.

Statistics:

  • 12 patients participated in the study, consisting of six men and six women.
  • The patients had a mean age of 54.5 years (standard deviation: 11.0 years).
  • The duration of diabetes was 16.5 years (standard deviation: 10.6 years).
  • The hemoglobin Alc level was 7.5% (standard deviation: 0.7%).
  • The body mass index was 29.5 kg/m^2 (standard deviation: 7.2 kg/m^2).
  • The insulin plasma levels (area under the curve vs. time) were 66,232 pmol/L (standard deviation: 4,521 pmol/L) after Exubera and 48,852 pmol/L (standard deviation: 2,999 pmol/L) after FlexPen.
  • The glucose infusion rate was significantly higher after Exubera compared to FlexPen.

Sources:

  • Forst, T., et al. (2009). Time-Action Profile and Patient Assessment of Inhaled Insulin via the Exubera Device in Comparison with Subcutaneously Injected Insulin Aspart via the FlexPen Device. Diabetes Technology & Therapeutics, 11(2), 87-92.
  • For additional information, contact T. Forst, Institute Clinic Research & Development, Parcusstr 8, D-55116 Mainz, Germany.
  • Publisher contact information for the journal Diabetes Technology & Therapeutics: Mary Ann Liebert Inc., 140 Huguenot Street, 3RD FL, New Rochelle, NY 10801, USA.