DiabetesPhase 1NCT01120912
Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients
A Phase 1 study testing Oshadi Oral Insulin in people with Diabetes, run by Oshadi Drug Administration at 1 site in Israel.
Trial summary
The study will be a non-randomized, open label, single dose, single blind, placebo control, single center, single arm study in Type I diabetes patients. The study will include single dose administration for the evaluation of single dose acute toxicity, pharmacokinetics and activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Oshadi Oral Insulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to Feb 2011
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable type I diabetes mellitus.
- Male/female 18 years old and up.
- Glucose level is treated only by s.c basal/bolus insulin injection (not by insulin pump) at least 48 hours prior to study initiation.
- 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.
- Patients must be sterile or infertile or use an approved method of contraception from the time that the first dose of study medication is taken until three months following study completion or discontinuation.
Who cannot join
- 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.
- Patients with positive HIV serology or positive HBsAg at screening.
- History or evidence of any active liver disease.
- C-peptide > 3 mg/ml (fasting).
- Hba1c<10.
- eGFR>60.
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- Female patients who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
- 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.
- Mall absorption disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Non-randomized, Single Blind, Placebo Controlled, Single Dose Study of the Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients - Phase 1 Study
The study will be a non-randomized, open label, single dose, single blind, placebo control, single center, single arm study in Type I diabetes patients. The study will include single dose administration for the evaluation of single dose acute toxicity, pharmacokinetics and activity.
- Conditions
- Diabetes
- Being tested
- Oshadi Oral Insulin
- Keywords
- oral insulin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oshadi Oral InsulinDrug
Oral insulin single administration
| Study group | Role | What they receive |
|---|---|---|
| Oral insulin and placebo | Experimental | Not described Receives: Drug: Oshadi Oral Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events occurrence
Measured: one month
Secondary outcomes (1)
Evaluate the glucose lowering effect of Oshadi Oral Insulin
Measured: 12 hours following administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oshadi Drug Administration
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanna Levy, Dr., Study director, Oshadi Drug Administration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120912
- Sponsor's protocol ID
- OS-INS-P1-01
- Status last verified
- Feb 2011
- First submitted
- 8 May 2010
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Non-randomized, Single Blind, Placebo Controlled, Single Dose Study of the Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients - Phase 1 Study
- ClinicalTrials.gov ID
- NCT01120912
- Acronym / sponsor ID
- OS-INS-P1-01
- Conditions
- Diabetes
- Keywords
- oral insulin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Oshadi Drug AdministrationIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 May 2010 (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 study will be a non-randomized, open label, single dose, single blind, placebo control, single center, single arm study in Type I diabetes patients. The study will include single dose administration for the evaluation of single dose acute toxicity, pharmacokinetics and activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral insulin and placebo | Experimental | Drug: Oshadi Oral Insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stable type I diabetes mellitus.
- Male/female 18 years old and up.
- Glucose level is treated only by s.c basal/bolus insulin injection (not by insulin pump) at least 48 hours prior to study initiation.
- 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.
- Patients must be sterile or infertile or use an approved method of contraception from the time that the first dose of study medication is taken until three months following study completion or discontinuation.
Key exclusion criteria (16 listed)
- 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.
- Patients with positive HIV serology or positive HBsAg at screening.
- History or evidence of any active liver disease.
- C-peptide > 3 mg/ml (fasting).
- Hba1c<10.
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 |
|---|---|---|
| Oshadi Oral InsulinOral insulin single administration | Drug | Oral insulin and placebo |
Primary outcome
Adverse events occurrence
Time frame: one month
1 secondary outcome
Evaluate the glucose lowering effect of Oshadi Oral Insulin
Time frame: 12 hours following administration
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 17 Apr 2012.
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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.
Hanna Levy, Dr. study director
Oshadi Drug Administration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oshadi Oral Insulin in people with Diabetes, run by Oshadi Drug Administration 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 16 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 17 Apr 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse events occurrence (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2012.