Overview

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