Phase 2Completed
Efficacy Safety and Tolerability of Multiple Doses of Oshadi Icp (Oshadi Oral Insulin) in Patients With Type 1 Diabetes Mellitus - Phase II Clinical Study
A Single Center, Multiple-dose, Non-randomized, Dose Adjustment, Open-Label Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Tolerability of Oshadi Icp in Patients With Type 1 Diabetes Mellitus -A Phase II Clinical Study
- Sponsor
- Oshadi Drug Administration (Industry)
- Enrolment
- 12 enrolled
- Conditions
- Diabetes Mellitus; Insulin-Dependent; Type 1
- Interventions
- Oshadi Icp
- Ages
- adults, older adults
- Registry
- NCT01973920
Full record on ClinicalTrials.gov
From the registry
Diabetes mellitus (DM) is a chronic disease of carbohydrate, fat, and protein metabolism caused by an absolute or relative deficiency of insulin, an anabolic hormone. The current methods of insulin therapy for diabetic patients are multiple daily injection therapy and continuous subcutaneous insulin infusion with an external pump. This rout of administration may lead to hyperinsulinemia as insulin is administered in a non physiological way, targeting mainly extra hepatic tissues (muscle, fat). A method of providing insulin without the need for injections has been a goal in drug delivery. Oshadi Drug Administration Ltd. has developed oral carrier for proteins based on biochemistry and quantum theory of biochemical reactions. The carrier enables the absorption of proteins from the gastrointestinal tract in their full structure. Oshadi has also developed the Oshadi Icp - insulin, proinsulin and C-peptide in Oshadi carrier, administrated orally. This study was design in order to evaluate the safety and feasibility of multiple administrations of Oshadi Icp for home use. The study will…
Primary outcomes
- Adverse events and serious adverse events occurence
History
Last registry update
Primary completion
Started
Registered