Pharmacokinetic and Pharmacodynamic Effects of Insulex® R in Comparison to Humulin® R in Healthy Subjects

Summary

The goal of this clinical trial is to evaluate whether Insulex® R demonstrates similar pharmacokinetic (PK) and pharmacodynamic (PD) profiles compared to Humulin® R after a single subcutaneous dose of 0.3 units/kg in healthy adult volunteers.

Timeline

Start

2024-10-24

Primary completion

2025-02-01

Completion

2025-05-07

Publications

• Background DeWitt DE, Hirsch IB. Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: scientific review. JAMA. 2003 May 7;289(17):2254-64. doi: 10.1001/jama.289.17.2254.
• Background DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
• Background Chance RE, Frank BH. Research, development, production, and safety of biosynthetic human insulin. Diabetes Care. 1993 Dec;16 Suppl 3:133-42. doi: 10.2337/diacare.16.3.133.
• Results Vocelka CR, Burdge EC, Kunzelman KS, Thomas R, Verrier ED. An in vitro protocol for evaluation and comparison of membrane oxygenators. J Extra Corpor Technol. 1993;25(4):161-6.
• Results Yamada N, Chung YS, Takatsuka S, Arimoto Y, Sawada T, Dohi T, Sowa M. Increased sialyl Lewis A expression and fucosyltransferase activity with acquisition of a high metastatic capacity in a colon cancer cell line. Br J Cancer. 1997;76(5):582-7. doi: 10.1038/bjc.1997.429.
• Results Colombo TJ, Saward EW, Greenlick MR. The integration of an OEO health program into a prepaid comprehensive group practice plan. Am J Public Health Nations Health. 1969 Apr;59(4):641-50. doi: 10.2105/ajph.59.4.641. No abstract available.
• Results Guerci B, Sauvanet JP. Subcutaneous insulin: pharmacokinetic variability and glycemic variability. Diabetes Metab. 2005 Sep;31(4 Pt 2):4S7-4S24. doi: 10.1016/s1262-3636(05)88263-1.

Drugs

Indications

No indication recorded.