Insulin Exposure and Glucose Response to Meals in Type 1 Diabetic Subjects Administered Two Different Insulin Regimens Compared to the Endogenous Insulin Exposure and Glucose Response to Meals In Healthy Adult Controls

Inclusion Criteria:

• Diabetic Subjects

  1. 12 adults (males or females) with Type 1 Diabetes, aged 18 to 55 years.
  2. C-peptide-negative
  3. Body mass index < 29.0 kg/m2

• Healthy Subjects

  1. 12 non-smoking adults (males or females), aged 18 to 55 years
  2. Normal response to an oral glucose tolerance test (OGTT)
  3. Body mass index < 29.0 kg/m2

Exclusion Criteria:

• Diabetic Subjects

  1. Hemoglobin A1c >9%
  2. Total daily insulin requirements >0.8 units/kg actual body weight
  3. History of hypoglycemia that required the subject to see medical attention (i.e., doctor's office visit, ER visit, or EMT/paramedic attention) within 6 months of the study.
  4. History of acute metabolic complications within 3 months of the study
  5. History of lipodystrophy.
  6. History of or suspected diabetic gastroparesis or current treatment with any drugs known to affect gastrointestinal motility.
  7. Inability or unwillingness to administer subcutaneous insulin injections in the abdomen.
  8. Any past or present clinically relevant abnormality, medical condition, or circumstance making the subject unsuitable for participation in the study.
  9. Active peptic ulcer disease or a history of gastrointestinal surgery within the last 6 months years.
  10. History of malignancy (except basal cell carcinoma and carcinoma in situ) within the last 5 years.
  11. Pregnant or lactating females or females of childbearing potential who are unwilling to abstain from sexual intercourse or use reliable, medically accepted methods of contraception.
  12. History of alcoholism or drug abuse within 12 months of the study.
  13. Is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, other study staff, or relative thereof directly involved in the conduct of this protocol.

• Healthy Subjects

  1. Hemoglobin A1c >6.0%
  2. Any past or present clinically relevant abnormality, medical condition, or circumstance making the subject unsuitable for participation in the study.
  3. Historical, clinical, or laboratory evidence of liver disease including but not limited to transaminase activity concentrations >2.5 times the upper limit of the reference range.
  4. Current treatment with any drugs known to affect gastrointestinal motility.
  5. Active peptic ulcer disease or a history of gastrointestinal surgery within the last 6 months.
  6. History of malignancy (except basal cell carcinoma and carcinoma in situ) within the last 5 years.
  7. Pregnant or lactating females or females of childbearing potential who are unwilling to abstain from sexual intercourse or use reliable, medically accepted methods of contraception.
  8. History of alcoholism or drug abuse within 12 months of the study.
  9. Is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, other study staff, or relative thereof directly involved in the conduct of this protocol.