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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
| Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
| Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
| Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
| Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
| Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
| Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
| Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
| Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
| Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
| Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
| Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
| Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
| Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
| Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
| Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
| Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
| Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A |