Dose Response Study of Transdermal Human Insulin in Patients

Exclusion Criteria

• •1. The subject has any relevant deviations from normal other than blood glucose in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.
• •2. The subject has had more than 2 hypoglycemic events in the last month.
• •3. The subject's normal insulin dose is less than 10 and more than 200 IUs.
• •4. Subjects receiving Insulin from an implanted or external insulin pump system.
• •5. The subject has had a clinically significant illness or surgical procedure within 30 days preceding entry into this study.
• •6. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease other than T2D.
• •7. The subject has a known allergy or history of hypersensitivity to Human Insulin or similar modified Insulin compounds.
• •8. The subject has used any prescription medication that may interfere with the evaluation of study medication.
• •9. The subject has donated or lost a significant volume of blood (\>450 mL) within four (4) weeks of the study, and subject's Hemoglobin concentration and hematocrit have not returned to within 5% of normal.
• •10. The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test.
• •11. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).
• •12. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.