Human Clinical Trial Test Results Comparison of PKA Micro-Needle Device and Subcutaneous Injection
Objective:
To compare the efficiency of PKA Micro-Needle based intra-dermal & epidermal drug delivery system with subcutaneous injection dose of human insulin after a standard breakfast meal in subjects with Type-1 Diabetes. We used Ely-Lilly’s Rapid Acting Humalog insulin drug for the trial.
Study Design:
(20 male or female volunteers with Type-1 Diabetes)
Patients: received two treatments in a randomized fashion on separate days:
1. Insulin Injection*
2. PKA Micro-Needle Device*
*each with (Humalog, Lilly) 7 units at time 0 minutes. All subjects to consume 360 calories (Boost or Ensure Plus Liquid Meals) 10 minutes after
Below:
(Insulin Levels (uU/mL)
*Absorption of insulin through the intra-dermal route was significantly faster when compared to subcutaneously injected rapid acting insulin (humalog)
*30 mins & 60 mins postprandial glucose level rapidly lowered with PKA Micro-Needle device vs. Subcutaneous injected group
*Humalog peaked approximately 50% faster with 30 mins of intra-dermal injection (Tmax=30mins
*Attributed to more rapid absorption of insulin through intra-dermal interstitial fluid with PKA Micro-Needle injection
*No pain with the PKA Micro-Needle injection; patients never felt the pricking pain that is associated with the subcutaneous injection
The following article was written by two of PKA SoftTouch’s founders: Dr. Pankaj Modi and Maneesh Khanna – together with Marko Mihic.
The article provides information on early testing and results of the Micro-Needle.
Advanced Devices Article
Veterinary Pharmacology and Therapeutics
Micro-Injection Atropine Study