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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oshadi Drug Administration
ClinicalTrials.gov Identifier:
NCT01772251
First received: January 17, 2013
Last updated: October 27, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Insulin-Dependent, 1
Drug: Oshadi Icp
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Oshadi Drug Administration:

Primary Outcome Measures:
  • Adverse events and serious adverse events occurence [ Time Frame: last follow-up visit (day 23) ] [ Designated as safety issue: Yes ]

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 [ Time Frame: last administration day (day 17) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • • Evaluating the total daily injected insulin dose during administration of Oshadi Icp vs. placebo [ Time Frame: Last administration day (day 17) ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: February 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oshadi Icp & placebo Drug: Oshadi Icp
Other Name: Oral insulin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772251

Locations
Israel
Assaf-Harofeh Medical Center
Zerifin, Israel
Sponsors and Collaborators
Oshadi Drug Administration
  More Information

No publications provided

Responsible Party: Oshadi Drug Administration
ClinicalTrials.gov Identifier: NCT01772251     History of Changes
Other Study ID Numbers: OS-ICP-P1b-01, 2012-004270-26
Study First Received: January 17, 2013
Last Updated: October 27, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Oshadi Drug Administration:
Diabetes Mellitus
Oral Insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014