drugset / Trial / NCT02535715
A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED)
Phase 2
Completed
11 enrolled
The University of Texas Health Science Center at San Antonio
Oramed, Ltd. · collab
Non-randomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2015-01
- Primary completion
- 2017-04
- Completion
- 2017-04
Publications
- Background Polonsky WH, Fisher L, Guzman S, Villa-Caballero L, Edelman SV. Psychological insulin resistance in patients with type 2 diabetes: the scope of the problem. Diabetes Care. 2005 Oct;28(10):2543-5. doi: 10.2337/diacare.28.10.2543. No abstract available.
- Background DeFronzo RA, Ferrannini E, Simonson DC. Fasting hyperglycemia in non-insulin-dependent diabetes mellitus: contributions of excessive hepatic glucose production and impaired tissue glucose uptake. Metabolism. 1989 Apr;38(4):387-95. doi: 10.1016/0026-0495(89)90129-7.
- Background STEELE R. Influences of glucose loading and of injected insulin on hepatic glucose output. Ann N Y Acad Sci. 1959 Sep 25;82:420-30. doi: 10.1111/j.1749-6632.1959.tb44923.x. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ORMD-0801 | Protein / enzyme biologic | 16 mg | Oral |
| Subject | ORMD-0801 | Protein / enzyme biologic | 24 mg | Oral |