Regular Insulin vs Rapid Insulin Delivered by V-Go

Exclusion Criteria

• •1. Subject with confirmed Type 1 diabetes
• •2. More than 1 episode of severe hypoglycemia (defined as requiring third party assistance) within 3 months of study entry
• •3. History of hypoglycemia unawareness
• •4. Require supplemental insulin in addition to V-Go therapy
• •5. Woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study. Women of childbearing potential are defined as any female who has experienced menarche and who it NOT permanently sterile of postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without and alternative medical cause.
• •6. Woman who are lactating.
• •7. Use of any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
• •8. A recipient of a solid organ transplant
• •9. Current use of U-100 RHI in V-Go within 90 days of screening
• •10. Current use of U-500 RHI in V-Go within 90 days of screening
• •11. Currently on dialysis
• •12. Medical or other problems which in the opinion of the investigator will render study participation unsafe.