Diabetes Mellitus Clinical Trial
Official title:
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
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 be a multiple-dose, open-label non-randomized study
in patients with Type 1 diabetes, with periodic dose adjustments. The study will include 4
weeks of multiple-dose administration of Oshadi oral insulin (Oshadi Icp) at home and in
study center for the determination of the efficacy, safety and pharmacodynamic effects of
Oshadi Icp.
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