OR14-1 Pharmacodynamics, Safety, Tolerability, and Efficacy of Oral Insulin Formulation (Oshadi Icp) among Young Adults with Type 1 Diabetes: A Summary of Clinical Studies Phases I, Ib, and Ii
| Autor: | Avital Leshem, Keren Doenyas-Barak, Roy Sagi, Shlomit Koren, Galia Barash, Marianna Rachmiel |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Insulin pump medicine.medical_specialty Type 1 diabetes business.industry Endocrinology Diabetes and Metabolism Insulin medicine.medical_treatment Area under the curve 030209 endocrinology & metabolism medicine.disease Placebo Diabetes Mellitus and Glucose Metabolism Gastroenterology New Treatments for Type 1 Diabetes and the Pathophysiology of Microvascular Complications 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Tolerability Pharmacodynamics Internal medicine medicine Hyperinsulinemia business |
| Zdroj: | Journal of the Endocrine Society |
| ISSN: | 2472-1972 |
| DOI: | 10.1210/js.2019-or14-1 |
| Popis: | Background Replacement of subcutaneous (SC) insulin by oral insulin for Type I diabetes (T1D) could promote patient compliance and minimize hyperinsulinemia. Oshadi Drug Administration Ltd. has developed an oral carrier for proteins delivery, composed of known ingredients, including polysaccharides and nano-silica , and based on quantum theory of biochemical reactions. Objectives To assess the pharmacodynamics of Oshadi oral insulin formulation (Oshadi-I) and the safety, tolerability and glucose-lowering effect of Oshadi oral insulin, proinsulin and c-peptide formulation (Oshadi-Icp) in young patients with T1D. Methods Phase I: a single blinded crossover between Oshadi-I and placebo. Glucose concentration was followed over 13 hours post a single dose. Phase Ib: a crossover open label comparison between 2 sessions of 3 days of Oshadi-Icp or placebo. During both sessions patients stayed at the research unit, provided with identical low carbs diet and minimal doses of SC insulin. Phase II:a prospective 4 weeks open-label follow-up of patients using an insulin pump combined with Oshadi-Icp at home. During Phases Ib and II iinterstitial glucose (IG) was monitored by CGMS, and capillary glucose by finger pricks (CG). Mean IG, mean CG, their area under the curve (AUC), weight adjusted total daily dose (TDD) of SC insulin, BMI, HbA1c, fructosamine, and safety parameters were compared. Results Eight patients, mean age 27.7±4.8 years, 5 males, were included in Phase I study, 10 patients mean age 26.2±4.7 years, 7 males, were included in Phase Ib study, and 16 patients mean age 23.5± 4.6 years, 12 males, were included in Phase II study. Oshadi-Icp was well tolerated, with no adverse events nor clinically relevant changes in vital signs, electrocardiograms, and standard safety laboratory parameters during all study phases. Phase I demonstrated a significantly lower plasma glucose AUC within 7 hours post Oshadi-I compared with placebo: 1116.1mg/dl±107.0 vs. 1345.7mg/dl ±82.0, p |
| Databáze: | OpenAIRE |
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