Diabetes Mellitus, Insulin-Dependent, 1 Clinical Trial
Official title:
A Single-Center, Multiple-dose, Randomized, Cross-Over, Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacodynamics, Safety, and Tolerability of Oshadi Icp In Patients With Type 1 Diabetes Mellitus - Phase Ib Clinical Study
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 administration of Oshadi Icp
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04503564 -
"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM)
|
N/A | |
| Completed |
NCT05168657 -
Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth
|
N/A | |
| Completed |
NCT01781975 -
Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus
|
Phase 2 | |
| Terminated |
NCT04591925 -
SteadiSet™ Pilot Study (SteP Study)
|
N/A |