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

Diabetes Mellitus, Insulin-Dependent, 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772251
• Other study ID #: OS-ICP-P1b-01
• Secondary ID: 2012-004270-26
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 17, 2013
• Last updated: October 27, 2013
• Start date: February 2013
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Oshadi Drug Administration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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 administration of Oshadi Icp

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Insulin-Dependent, 1
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Oshadi Icp

Locations

Country	Name	City	State
Israel	Assaf-Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Oshadi Drug Administration

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	• Evaluating the total daily injected insulin dose during administration of Oshadi Icp vs. placebo		Last administration day (day 17)	No
Primary	Adverse events and serious adverse events occurence		last follow-up visit (day 23)	Yes
Secondary	• 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 17)	No