Patient Preference of h-Patch vs. Pen or Needle/Syringe as Insulin Administration Device

Exclusion Criteria

• •1. Recurrent major hypoglycemia or prolonged unstable blood glucose control (as judged by the Investigator).
• •2. Use of other diabetes drugs including α-glucosidase inhibitors, meglitinides, pramlintide, exenatide or DPP-IV inhibitors (metformin and/or a thiazolidinedione and/or a sulfonylurea are allowed).
• •3. Intend to use any other concomitant drug therapy (prescription or over-the-counter medications) that can affect blood glucose levels.
• •4. Have used systemic glucocorticoids within 1 month prior to Screening or currently on glucocorticoids.
• •5. Have a history of drug or alcohol abuse within 1 year prior to Screening Visit.
• •6. Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, or neurological disease that would, in the investigator's opinion, preclude safe participation in the study.
• •7. Have a history of major surgery, e.g. laparotomy, thoracotomy, open orthopedic procedure, etc. within 3 months prior to Screening Visit.
• •8. Evidence of significant neuropsychiatric disease.
• •9. Have participated in a medical, surgical, or pharmaceutical investigational new drug/device study in the last 30 days or ≤ 5 half-lives of the investigational drug, whichever is longer, prior to Screening Visit.
• •10. Blood donation of 500 ml or more in the last 2 months prior to Screening Visit.
• •11. Evidence of significant active hematological disease.
• •12. Acute infection with fever.
• •13. Hemoglobin \< 10 g/dL; AST, ALT ≥ 1.5 times the upper reference limit at Screening.
• •14. Uncontrolled treated/untreated hypertension (systolic blood pressure \> 155 mmHg and diastolic blood pressure \> 90 mmHg).
• •15. History of proliferative retinopathy or maculopathy requiring acute treatment
• •16. Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation.
• •17. Any condition that the Investigator and/or Sponsor feel would interfere with trial participation or evaluation of results
• •18. Pregnancy, breast-feeding, intention of becoming pregnant for female patients of child-bearing potential.
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