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Diabetes Mellitus Type 1Phase 2NCT02094534

A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics

A Phase 2 study testing ORMD-0801 Capsules in people with Diabetes Mellitus Type 1, run by Oramed, Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This will be a prospective, randomized, double-blind, placebo controlled study. Patients with established Type 1 diabetes will be eligible for entry into the study. Eligible patients will be screened and those who fulfill all inclusion/exclusion criteria will be admitted to the inpatient unit no fewer than 2 days and… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Diabetes Mellitus Type 1
What is being tested?
ORMD-0801 Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteUnited States
Study dates
Mar 2014to Oct 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Males and Females age 18 to 55 years old, inclusive.
  • Patients must be willing and able to sign informed consent.
  • Documented history of Type 1 Diabetes for at least 6 months
  • Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urinary screening test following admission to the inpatient unit

Who cannot join

  • Presence of any clinically significant endocrine disease according to the Investigator (euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least six weeks prior to Screening)
  • Fasting plasma glucose >260 mg/dL at the end of run-in
  • Evidence of unawareness of hypoglycemia with a documented plasma glucose ≤50 mg/dL in the absence of symptoms of hypoglycemia
  • Presence of any clinically significant condition that might interfere with the evaluation of study medication (i.e., significant renal, hepatic, gastrointestinal (GI), cardiovascular (CV), immune disease).
  • Presence or history of cancer within the past five years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer
  • Laboratory abnormalities at screening including:
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  • Positive pregnancy test in females of childbearing potential (at screening and Day -3 of Visit 2)
  • Abnormal serum thyrotropin (TSH) levels >1.5X upper limit of normal (ULN)
  • Positive test for hepatitis B surface antigen and/or hepatitis C antibody
  • Positive test for HIV
  • Any relevant abnormality interfering with the efficacy or the safety assessments during study drug administration
  • Use of the following medications:
  • o History of use of aprotinin at any time prior to the screening visit (e.g., Trasylol, any type or dose)
  • Administration of thiazolidinedione [e.g., (Actos (pioglitazone) and Avandia (rosiglitazone)] treatment within 3 months prior to randomization.
  • Administration of thyroid preparations or thyroxine (except in patients on stable replacement therapy) within 6 weeks prior to screening visit
  • Administration of systemic long-acting corticosteroids within two months or prolonged use (more than one week) of other systemic corticosteroids or inhaled corticosteroids (if daily dosage is > 1,000 μg equivalent beclomethasone) within 30 days prior to screening visit
  • Use of medications known to modify glucose metabolism or to decrease the ability to recover from hypoglycemia such as oral, parenteral, and inhaled steroids (as discussed above), beta blockers (with the exception of beta blocker ophthalmic solutions for glaucoma or ocular hypertension), and immunosuppressive or immunomodulating agents
  • History of severe or multiple allergies, or known allergy to soy or aprotinin.
  • History of tobacco or nicotine use within 10 weeks prior to screening
  • Patient is on a weight loss program and is not in the maintenance phase, or patient that started weight loss medication (e.g., orlistat or sibutramine) within 8 weeks prior to screening
  • Pregnancy or breast-feeding
  • Patient has a screening visit systolic blood pressure of ≥165 mmHg or diastolic blood pressure of ≥100 mmHg.
  • Patient is, at the time of consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. (Note: Alcohol abuse includes heavy alcohol intake as defined by >3 drinks per day or >14 drinks per week, or binge drinking)
  • Elevated liver enzymes (alanine transaminase (ALT), alanine aminotransferase (AST), alkaline phosphatase) greater than 2 times the upper limit of normal (ULN) at Screening
  • Very high triglyceride level (>600 mg/dL) at Screening
  • Any clinically significant electrocardiogram (ECG) abnormality at screening or cardiovascular disease. Clinically significant cardiovascular disease will include:
  • history of stroke, transient ischemic attack, or myocardial infarction within 6 months prior to screening,
  • history of or currently have New York Heart Associate Class II-IV heart failure prior to screening, or
  • uncontrolled hypertension defined as (duplicate seated reading) blood pressure ≥165 mmHg (systolic) or ≥100 mmHg (diastolic) at screening or at Visit 2.
  • History of gastrointestinal disorders (e.g. hypochlorhydria) with the potential to interfere with drug absorption
  • At the Principal Investigator's discretion, any condition or other factor that is deemed unsuitable for patient enrollment into the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Orange County Research Center

    Tustin, California, 92780

Other trials in United States

About this study

This will be a prospective, randomized, double-blind, placebo controlled study. Patients with established Type 1 diabetes will be eligible for entry into the study. Eligible patients will be screened and those who fulfill all inclusion/exclusion criteria will be admitted to the inpatient unit no fewer than 2 days and no more than 7 days after Screening. Patients will report to the inpatient unit at 6 a.m. and outfitted with a continuous glucose monitoring (CGM) device. Patients will be given standardized meals and snacks for the duration of their inpatient visit.

Read the detailed description

For the first 3 days, patients will be dosed with placebo 45 minutes prior to each of the day's 3 meals to establish baseline insulin requirements. Patients will be dosed with exogenous insulin according to their normal sliding scale and each patient's daily insulin requirement will be documented. The average daily insulin requirements during the 3 day run-in period will constitute the patient's baseline insulin level.

Following the 3 day run-in, the CGM device will be detached, its data download, and the patient refitted with the CGM with a fresh cannula for continued monitoring during the 7-day treatment period.

Patients will be randomized 2:1 to receive ORMD-0801 or placebo for the 7-day double-blind treatment period.

Being tested
ORMD-0801 Capsules, Placebo
Keywords
Diabetes type 1, Oral Insulin, Safety, Tolerability, Phase 2a, Randomized, Blinded, Parallel
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ORMD-0801 CapsulesBiological

    Also called Oral Insulin

    API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules.

  • PlaceboOther

    Also called Fish Oil

    Fish oil capsules, identical in appearance to the experimental intervention.

Study groups in NCT02094534
Study groupRoleWhat they receive
ORMD-0801 CapsulesExperimentalAPI (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801
Receives: Biological: ORMD-0801 Capsules
PlaceboPlacebo comparatorFish oil in capsules, identical in appearance to ORMD-0801
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements

    Change from baseline (Run-in Average) to treatment days 6 and 7 (average of day 6 and 7) in exogenous insulin requirements in patients treated with ORMD-0801 compared to patients treated with placebo.

    Measured: Baseline:Run-In Average (run in days 1-7), and treatment (day 6 and day 7)

Secondary outcomes (1)

  1. Mean Nighttime, Daytime, and Fasting Glucose Levels

    Mean glucose levels (by continuous glucose monitoring (CGM)) in Type 1 diabetes patients treated with ORMD-0801, compared to the mean glucose levels (by continuous glucose monitoring) for patients treated with placebo.

    Measured: last two days (day 6 and day 7, averaged)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionAug 2014
  4. Study completionOct 2014

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02094534
Sponsor's protocol ID
ORA-D-010
Status last verified
Jun 2017
First submitted
20 Mar 2014
Last updated
6 Jul 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ORMD-0801 Capsules in people with Diabetes Mellitus Type 1, run by Oramed, Ltd. at 1 site in United States.

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 4 inclusion and 31 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 6 Jul 2017. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 6 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements (time frame: Baseline:Run-In Average (run in days 1-7), and treatment (day 6 and day 7)). 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 NCT02094534.

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 6 Jul 2017.

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