A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Intervention: ORMD-0801 capsules- 2x8mg; ORMD-0801 capsules- 3x8mg; ORMD-0801 capsules- 1x16mg
Intervention description: Participants who receive this intervention first, then receive either ORMD-0801- 3x8mg or 1x16mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.; Participants who receive this intervention first, then receive either ORMD-0801- 2x8mg or 1x16mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.; Participants who receive this intervention first, then receive either ORMD-0801- 2x8mg or 3x8mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Oral Insulin

Summary:

      ORAMED has developed an oral insulin that, in preliminary studies, has shown promise. In the
      present study investigators will perform a pharmacodynamic/pharmacokinetic study to evaluate
      this novel insulin preparation as a potential therapeutic option in diabetic patients.
    

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