Safety and Tolerability of Oshadi Icp In Patients With Type 1 Diabetes Mellitus - Phase Ib Clinical Study

October 27, 2013 updated by: Oshadi Drug Administration

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

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zerifin, Israel
        • Assaf-Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes mellitus (according to ADA criteria) for more than 1 year.
  • Male/female 18 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.

Exclusion Criteria:

  • 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 in the last 6 months
  • Patients with positive HIV or HCV serology or positive HBsAg at screening.
  • History or evidence of any active liver disease.
  • History of epilepsy.
  • One hypoglycemic seizure episode in the last six months or more than one hypoglycemic seizure episode in the last year.
  • History of sever recurrent hypoglycemic unawareness.
  • C-peptide >3 mg/ml (fasting)
  • Total average daily insulin dosage ≥1 IU/kg of body weight.
  • Polycystic ovary syndrome
  • Acanthosis nigricans
  • 6.5% > HbA1c or HbA1c >10%
  • eGFR<60.
  • 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
  • History of alcohol or drug abuse within 6 months of screening.
  • Patients who have a positive urine drug screen for substances of abuse (benzodiazepine, THC, opiates, amphetamines, cocaine) at the screening.
  • Mental disorders.
  • Patients with poor venous access
  • Significant swallowing disorders
  • Digestive disorders
  • Small bowel surgery
  • Any intercurrent disease during the last week prior to screening which in the judgment of the investigator might affect blood glucose level.
  • Any infectious disease developed during the 4 weeks prior to the study.
  • Malabsorption disorders.
  • Any significant abnormality by principal investigator in the baseline laboratory evaluation: liver and kidney functions, electrolytes, albumin, lipase, TSH, hemoglobin, white blood cell count and differential, platelets.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oshadi Icp & placebo
Other Names:
  • Oral insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events and serious adverse events occurence
Time Frame: last follow-up visit (day 23)
last follow-up visit (day 23)

Secondary Outcome Measures

Outcome Measure
Time Frame
• To assess the pharmacodynamic effect of multiple doses of Oshadi Icp as measured by the area under the glucose concentration-time curve
Time Frame: last administration day (day 17)
last administration day (day 17)

Other Outcome Measures

Outcome Measure
Time Frame
• Evaluating the total daily injected insulin dose during administration of Oshadi Icp vs. placebo
Time Frame: Last administration day (day 17)
Last administration day (day 17)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 17, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (Estimate)

January 21, 2013

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 27, 2013

Last Verified

June 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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