A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED)

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: Oramed, Ltd.
• Treatments: Insulin; Insulin, Globin Zinc

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