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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

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ClinicalTrials.gov Identifier: NCT01973920
Recruitment Status : Completed
First Posted : November 1, 2013
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Oshadi Drug Administration

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Insulin-Dependent Type 1 Drug: Oshadi Icp Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2013
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Oshadi Icp
Oshadi Icp oral insulin,
Drug: Oshadi Icp
Other Name: Oral insulin




Primary Outcome Measures :
  1. Adverse events and serious adverse events occurence [ Time Frame: last follow-up visit (day 60) ]

Secondary Outcome Measures :
  1. 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 Outcome Measures:
  1. Evaluating the total daily injected insulin dose during administration of Oshadi Icp vs routine use [ Time Frame: Last administration day (day 37) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973920


Locations
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Israel
Assaf-Harofeh Medical Center
Zerifin, Israel
Sponsors and Collaborators
Oshadi Drug Administration
Investigators
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Principal Investigator: Marianna Rachmiel, Dr. Assaf-Harofeh Medical Center, Israel

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Responsible Party: Oshadi Drug Administration
ClinicalTrials.gov Identifier: NCT01973920     History of Changes
Other Study ID Numbers: OS-ICP-P2 -01
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: March 2016

Keywords provided by Oshadi Drug Administration:
Diabetes Mellitus
Oral Insulin

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs