A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED)
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Oral Insulin
Eligibility Criteria
Inclusion Criteria:
- Must be between 18 and 70 years of age
- Must have type 1 diabetes
- Must be in good general health by routine history and physical exam
- A1c <10.0%
- BMI = 18-40 kg/m2
- On no medications known to affect glucose metabolism other than insulin
- Hematocrit ≥ 34 vol%
- Liver Function Tests < 3 x Upper Normal Limit
- Plasma creatinine < 1.8 mg/dl
Exclusion Criteria:
- Under 18 years of age and over 70 years of age
- Does not have type 1 diabetes
- A1c > 10.0%
- BMI < 18 or > 40 kg.m2
- On medications known to affect glucose metabolism other than insulin
- Hematocrit ≤ 34 vol%
- Liver Function Tests >3 x Upper Normal Limit
- Plasma creatinine > 1.8 mg/dl
Sites / Locations
- The University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
ORAMED ORMD-0801 capsules- 2x8mg 1st; 3x8mg 2nd, 1x16mg 3rd
ORAMED ORMD-0801 capsules- 3x8mg 1st, 1x16mg 2nd, 2x8mg 3rd
ORAMED ORMD-0801 capsules-1x16mg 1st, 2x8mg 2nd, 3x8mg 3rd
Two 8 mg ORAMED capsules containing insulin then 3X8mg ORAMED capsules containing insulin, second study then 1X16mg ORAMED capsules containing insulin, third study
Three 8mg ORAMED capsules containing insulin then 1X16mg ORAMED capsules containing insulin, second study then 2X8mg ORAMED capsules containing insulin, third study
One 16mg ORAMED capsule containing insulin then 2X8mg ORAMED capsule containing insulin, second study then 3X8mg ORAMED capsule containing insulin, third study