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Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients

This study has been completed.
Sponsor:
Collaborator:
Oramed Pharmaceutical Inc.
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00867594
First received: March 22, 2009
Last updated: August 10, 2011
Last verified: March 2008
History of Changes

March 22, 2009
August 10, 2011
July 2008
August 2008   (final data collection date for primary outcome measure)
To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00867594 on ClinicalTrials.gov Archive Site
To determine if oral insulin is likely to improve glycemic stability assessed by the reduction of the frequency and severity of hypoglycemic episodes in people with unstable type 1 diabetes [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
Same as current
 
 
 
Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients
A Single Blind, Open-Label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral Insulin Formulation in Type 1 Subjects

The intent of the proposed study is to assess the potential of oral insulin to mitigate diabetic instability and reduce the frequency and severity of hypoglycemic episodes in patients with type 1 diabetes. Restoring hepatic glycogen stores is critical for the normalization of counter-regulation to hypoglycemia in these patients. Oral insulin can provide a means to increase portal insulin levels, shift the ratio of insulin/glucagon in favor of glycogenesis while sparing the patient the risk of hypoglycemia due to peripheral hyperinsulinemia
 
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Brittle Type I Diabetes Mellitus
Drug: ORMD 0801
1 capsule ORMD 0801 3 times a day, before each meal
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2008
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes mellitus
  • Male or female aged 18-50 years inclusive
  • Body weight between 50-100kg and BMI between 18 and 30 kg/m2
  • Diagnosed 6 or more months ago, unstable diabetes with frequent episodes of hypoglycemia
  • No other medical problems

Exclusion Criteria:

  • History or presence of clinical significant gastrointestinal pathology or symptoms, liver or kidney disease or any condition that might interfere with the absorption, distribution, metabolism or excretion of the drug
  • Positive pregnancy test or lactation
  • Lack of family support
  • Unwilling or unable to follow the study protocol
  • Concurrent medical problems
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00867594
0566-08-HMO-CTIL
 
Dr. Roy Eldor, Hadassah Medical Organization, Jerusalem
Hadassah Medical Organization
Oramed Pharmaceutical Inc.
Principal Investigator: Roy Eldor Hadassah
Hadassah Medical Organization
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP