Clinical Data for the PKA Micro-needle Technology
HUMAN CLINICAL TRIAL TEST RESULTS (2004)
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.
Open Label, Randomized, Cross Over, Comparative Study 2004
(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)
TEST RESULTS & CONCLUSION
The following article was written by two of PKA SoftTouch’s founders: Dr. Pankaj Modi and Maneesh Khanna – together with Marko Mihic.