Development Progress
Total human exposures > 500
Reproducible delivery from capsule dosage forms demonstrated
Dosed in Type I and II patients
- Glucose clamp study
- Fed-fasted study (Answered whether oral insulin would be effective under real-life conditions before a meal?)
- Established that oral insulin / EMISPHEREŽ delivery agent has a therapeutic effect in Type I and Type II patients following their ingestion of a mixed meal
- Night-time insulin study
- 90-day toxicity data
- U.S. Phase I studies in Type 2 patients