Brittle Type I Diabetes MellitusPhase 2NCT00867594
Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients
A Phase 2 study testing ORMD 0801 in people with Brittle Type I Diabetes Mellitus, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Brittle Type I Diabetes Mellitus
- What is being tested?
- ORMD 0801
- Type of treatment
- Pill or oral medicine
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2008to Aug 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Brittle Type I Diabetes Mellitus
- Being tested
- ORMD 0801
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORMD 0801Drug
1 capsule ORMD 0801 3 times a day, before each meal
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes
Measured: 15 days
Secondary outcomes (1)
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
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startJul 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brittle Type I Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Oramed Pharmaceutical Inc.
- Investigators
- Roy Eldor, Principal investigator, Hadassah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867594
- Sponsor's protocol ID
- 0566-08-HMO-CTIL
- Status last verified
- Mar 2008
- First submitted
- 22 Mar 2009
- Last updated
- 11 Aug 2011
- Results posted
- No
Publications
Eldor R, Arbit E, Corcos A, Kidron M. Glucose-reducing effect of the ORMD-0801 oral insulin preparation in patients with uncontrolled type 1 diabetes: a pilot study. PLoS One. 2013 Apr 9;8(4):e59524. doi: 10.1371/journal.pone.0059524. Print 2013.
PubMed 23593142
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, Open-Label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral Insulin Formulation in Type 1 Subjects
- ClinicalTrials.gov ID
- NCT00867594
- Acronym / sponsor ID
- 0566-08-HMO-CTIL
- Conditions
- Brittle Type I Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Oramed Pharmaceutical Inc.
- Study start
- Jul 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORMD 08011 capsule ORMD 0801 3 times a day, before each meal | Drug | – |
Primary outcome
To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes
Time frame: 15 days
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
- Derived from this study: PubMed 23593142Eldor R, Arbit E, Corcos A, Kidron M. Glucose-reducing effect of the ORMD-0801 oral insulin preparation in patients with uncontrolled type 1 diabetes: a pilot study. PLoS One. 2013 Apr 9;8(4):e59524. doi: 10.1371/journal.pone.0059524. Print 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Eldor principal investigator
Hadassah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ORMD 0801 in people with Brittle Type I Diabetes Mellitus, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00867594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011.