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

Primary Purpose

Diabetes Mellitus, Insulin-Dependent, Type 1

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Oshadi Icp

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Oral Insulin

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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 (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
6.5% > 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
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 (tetrahydrocannabinol), opiates, amphetamines, cocaine) at the screening.
Mental disorders.
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 (thyroid-stimulating hormone), hemoglobin, white blood cell count and differential, platelets.

Sites / Locations

Assaf-Harofeh Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oshadi Icp

Arm Description

Oshadi Icp oral insulin,

Outcomes

Primary Outcome Measures

Adverse events and serious adverse events occurence

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01973920

First Posted

October 27, 2013

Last Updated

April 16, 2018

Sponsor

Oshadi Drug Administration

1. Study Identification

Unique Protocol Identification Number

NCT01973920

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

December 2013 (Actual)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oshadi Drug Administration

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Insulin-Dependent, Type 1

Keywords

Diabetes Mellitus, Oral Insulin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oshadi Icp

Arm Type

Experimental

Arm Description

Oshadi Icp oral insulin,

Intervention Type

Drug

Intervention Name(s)

Oshadi Icp

Other Intervention Name(s)

Oral insulin

Primary Outcome Measure Information:

Title

Adverse events and serious adverse events occurence

Time Frame

last follow-up visit (day 60)

Secondary Outcome Measure Information:

Title

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 37)

Other Pre-specified Outcome Measures:

Title

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

Time Frame

Last administration day (day 37)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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 (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 6.5% > 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 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 (tetrahydrocannabinol), opiates, amphetamines, cocaine) at the screening. Mental disorders. 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 (thyroid-stimulating hormone), hemoglobin, white blood cell count and differential, platelets.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marianna Rachmiel, Dr.

Organizational Affiliation

Assaf-Harofeh Medical Center, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assaf-Harofeh Medical Center

City

Zerifin

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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