Clinical Data

Human Clinical Trial Test Results Comparison of PKA Micro-Needle Device and Subcutaneous Injection

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:

Open Label, Randomized, Cross Over, Comparative Study
(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 dose. Blood samples for plasma glucose and insulin taken 30 minutes before liquid meal and after (15, 30, 60, 90, 120, 180, 240, 300 minutes)

Below: Comparison Insulin Injection vs Micro-Needle
(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