Efficacy Safety and Tolerability of Multiple Doses of Oshadi Icp (Oshadi Oral Insulin) in Patients With Type 1 Diabetes Mellitus - Phase II Clinical Study

NCT01973920 | Completed Phase 2

• 1 other identifier: OS-ICP-P2 -01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus; Insulin-Dependent; Type 1

Keywords

Diabetes Mellitus; Oral Insulin

Outcome Measures

Primary Outcomes (1)

• Adverse events and serious adverse events occurence

  last follow-up visit (day 60)

Secondary Outcomes (1)

• To assess the pharmacodynamic effect of multiple doses of Oshadi Icp as measured by the area under the glucose concentration-time curve

  Last administration day (day 37)

Other Outcomes (1)

• Evaluating the total daily injected insulin dose during administration of Oshadi Icp vs routine use

  Last administration day (day 37)

Study Arms (1)

Oshadi Icp

EXPERIMENTAL

Oshadi Icp oral insulin,

Drug: Oshadi Icp

Interventions

Oshadi Icp DRUG

Also known as: Oral insulin

Oshadi Icp

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes mellitus (according to ADA criteria) for more than 3 year.
• Male/female 21 years old and older.
• BMI≥18.5 and ≤25
• Female of childbearing age must commit to avoid pregnancy and use contraception during the study.
• Patients must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.

You may not qualify if:

• Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results.
• Symptomatic DKA (diabetic ketoacidosis)in the last 6 months
• Patients with positive HIV or HCV (hepatitis C virus)serology or positive HBsAg at screening.
• History or evidence of any active liver disease.
• History of epilepsy.
• One or more episodes of sever hypoglycemia during the last 12 months
• History of hypoglycemic unawareness.
• C-peptide \>3 mg/ml (fasting)
• Total average daily insulin dosage ≥1 IU/kg of body weight.
• Polycystic ovary syndrome
• Acanthosis nigricans
• % \> HbA1c or HbA1c \>10%
• eGFR\<60 (epidermal growth factor receptor).
• Female patients who are breastfeeding or have a positive pregnancy test at screening or at any time during the study and not willing to practice birth control during study period.
• Inability to give written informed consent

Sponsors & Collaborators

• Oshadi Drug Administration: lead

Study Sites (1)

Assaf-Harofeh Medical Center

Ẕerifin, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Marianna Rachmiel, Dr.

  Assaf-Harofeh Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2013
• First Posted: November 1, 2013
• Study Start: December 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 18, 2018

Record last verified: 2016-03

Locations

IL (1)