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Type 1 DiabetesPhase 2NCT04150107

A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes

A Phase 2 study testing ORMD-0801 Treatment A and ORMD-0801 Treatment B in people with Type 1 Diabetes, 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 study is a Phase 2 randomized, crossover study comparing ORMD-0801 given QD versus TID in subjects with T1D. Subjects with T1D will have a screening visit (Visit 1) during which they will be required to review and sign the informed consent form. Medical history and demographics will be collected. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
ORMD-0801 Treatment A and ORMD-0801 Treatment B
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
17 Oct 2019to 12 Mar 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects aged 18 and older.
  • Body mass index (BMI) of 19-30 kg/m2 at Screening and stable weight, with no more than 5 kg gain or loss in the 3 months prior to Screening.
  • T1D subjects must have:
  • A documented history of type 1 diabetes for at least 6 months
  • Should be on an MDI regimen
  • C peptide levels of ˂ 0.7 ng/mL
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  • HbA1C ≥ 6.5% to ≤10%
  • Females of childbearing potential must have a negative serum pregnancy test result at Screening.
  • Females who are not of childbearing potential are defined as:
  • post-menopausal (defined as at least 12 months with no menses in women ≥45 years of age) or
  • has had a hysterectomy and/or bilateral oophorectomy, or had bilateral tubal ligation or occlusion at least 6 weeks prior to Screening
  • Subjects who are of childbearing potential must:
  • agree to remain abstinent from heterosexual activity† or agree to use (or have their partner use) acceptable contraception to prevent pregnancy within the projected duration of the trial and for 14 days after the last dose of blinded investigational product. Two methods of contraception will be used to avoid pregnancy. Acceptable combinations of methods include: i. Use of one of the following double-barrier methods: diaphragm with spermicide and a condom; cervical cap and a condom; or a contraceptive sponge and condom ii. Use of hormonal contraception (any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent [including oral, subcutaneous, intrauterine and intramuscular agents, and cutaneous patch]) with one of the following: diaphragm with spermicide; cervical cap; contraceptive sponge; condom; vasectomy; or IUD. iii. Use of an IUD with one of the following: condom; diaphragm with spermicide; contraceptive sponge; vasectomy; or hormonal contraception (see above).
  • Vasectomy with one of the following: diaphragm with spermicide; cervical cap; contraceptive sponge; condom; IUD; or hormonal contraception (see above).
  • †Abstinence can be used as the sole method of contraception if it is in line with the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ethics committees. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.

Who cannot join

  • Clinical diagnosis of type 2 diabetes;
  • Evidence of unawareness of hypoglycemia unawareness, a documented plasma glucose ≤50 mg/dL in the absence of symptoms of hypoglycemia at Screening.
  • FPG >300 mg/dL at Screening; a single repeat test is allowable.
  • Use of the following medications:
  • Administration of thyroid preparations or thyroxine (except in subjects on stable replacement therapy) within 6 weeks prior to Screening.
  • 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. Intra-articular and/or topical corticosteroids are not considered systemic.
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  • Laboratory abnormalities at Screening including:
  • Abnormal serum thyrotropin (TSH) levels below the lower limit of normal or >1.5X the upper limit of normal
  • Elevated liver enzymes (alanine transaminase (ALT), alanine aminotransferase (AST), alkaline phosphatase) >2X the upper limit of normal.
  • Very high triglyceride levels (>600 mg/dL); a single repeat test is allowable.
  • Any relevant abnormality that would interfere with the efficacy or the safety assessments during study treatment administration.
  • Subject has a Screening systolic blood pressure ≥165 mmHg or diastolic blood pressure ≥100 mmHg. Subjects will be allowed to take a BP rescue medication.
  • Any clinically significant 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.
  • Presence of any clinically significant endocrine disease according to the Investigator (euthyroid subjects on replacement therapy will be included if the dosage of thyroxine is stable for at least six weeks prior to Screening).
  • Presence of any clinically significant condition (in the opinion of the Investigator) that might interfere with the evaluation of study medication, such as significant renal, hepatic, gastrointestinal (GI), cardiovascular (CV), immune disease, blood dyscrasias or any disorders causing hemolysis or unstable red blood cells, or clinically important hematological disorders (i.e. aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) at Screening.
  • History of gastrointestinal disorders (e.g. hypochlorhydria) with the potential to interfere with drug absorption.
  • Presence or history of cancer within the past 5 years of Screening, with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer.
  • A subject with a history of malignancy >5 years prior to Screening should have no evidence of residual or recurrent disease.
  • A subject with a history of melanoma, leukemia, lymphoma, or renal carcinoma is excluded.
  • Positive history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic hepatitis B or C, primary biliary cirrhosis, or active symptomatic gallbladder disease.
  • Positive history of HIV.
  • Known allergy to soy.
  • Subject is on a weight loss program and is not in the maintenance phase, or subject has started weight loss medication (e.g., orlistat or liraglutide), within 8 weeks prior to Screening. Subjects who have had bariatric surgery are also excluded.
  • S ubject is pregnant or breast-feeding.
  • Subject is a user of recreational or illicit drugs or has had a recent history (within 1 year of Screening) 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) at Screening.
  • At the Principal Investigator's discretion, any condition or other factor that is deemed unsuitable for subject 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

Official title: A Phase 2 Randomized, Open Label Crossover Study to Compare ORMD-0801 Given Once Daily at Bedtime to ORMD-0801 Given Three Times Daily (45-90 Minutes Before Meals) in Subjects With Type 1 Diabetes

This study is a Phase 2 randomized, crossover study comparing ORMD-0801 given QD versus TID in subjects with T1D. Subjects with T1D will have a screening visit (Visit 1) during which they will be required to review and sign the informed consent form. Medical history and demographics will be collected. Vital signs will be measured, physical exam will be performed, and blood and urine samples will be collected for hematology/chemistry/urinalysis

Placebo capsules will be given QD at bedtime during placebo run-in period 10 days prior to randomization.

Read the detailed description

This study is a Phase 2 randomized, crossover study comparing ORMD-0801 given QD versus TID in subjects with T1D. Subjects with T1D will have a screening visit (Visit 1) during which they will be required to review and sign the informed consent form. Medical history and demographics will be collected. Vital signs will be measured, physical exam will be performed, and blood and urine samples will be collected for hematology/chemistry/urinalysis. Eligible subjects will be scheduled to return to the clinic in 1 week (Visit 2). Subjects fulfilling all inclusion/exclusion criteria will have a CGM placed, provided with a diary, dispensed Placebo capsules and asked to return to the clinic in 10 Days (Visit 3, Day 1) for randomization. At Visit 3, data from CGM will be downloaded and diaries will be collected. Blood samples will be collected in fasting for chemistry and HbA1c. Subjects will be randomized to receive either ORMD-0801 24 mg given once daily at bedtime, or ORMD-0801 8 mg given three times a day, 45-90 minutes before meals.

Subjects will be instructed to continue their normal diet, and to adjust their basal and bolus insulin in the normal fashion. Subjects will be instructed to return to the clinic 10 days before Visit 5 (Visit 4, Day 18). At Visit 4, compliance will be assessed, IMP and diary dispensed and the CGM will be placed. Subjects will be instructed to return to the clinic in 10 days for Visit 5 (Day 28). At Visit 5 a fasting blood sample for chemistry panel and HbA1C will be drawn and after the diary has been collected and the CGM monitor removed, they will be crossed over to the alternate treatment regimen. IMP will be dispensed, and the subject will be asked to return 10 days before Visit 7 for Visit 6 (Day 46). At Visit 6, compliance will be checked, IMP and diary will be dispensed and the CGM will be placed. Subjects will be instructed to return in 10 days for Visit 7 (Day 56). At Visit 7 the CGM will be removed, compliance checked, the diary will be collected, and a blood sample will be drawn for a chemistry panel and HbA1C. A physical examination will be performed, and the subject will exit the study. Subjects will be provided with diaries at Visits 2, 4 and 6, and will be asked to capture the amount of basal and bolus exogenous insulin administered each day and calculate their carbohydrate count for all meals and snacks over the 10-day CGM monitoring period. Diaries will be collected at Visits 3, 5 and 7.

Conditions
Type 1 Diabetes
Being tested
ORMD-0801 Treatment A, ORMD-0801 Treatment B, Placebo
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 Treatment ADrug

    Also called Oral Insulin

    Treatment A: 24 mg (16 mg capsule + 8 mg capsule) Once Daily (QD) at bedtime

  • ORMD-0801 Treatment BDrug

    Also called Oral Insulin

    Treatment B: 8 mg (8 mg capsule) three times a day (TID) 45-90 minutes before meals

  • PlaceboOther

    Fish oil capsule

Study groups in NCT04150107
Study groupRoleWhat they receive
Placebo then Treatment A then Treatment BExperimentalTreatment administered in the following order: 1. Period 1: Placebo (Fish Oil Capsule) 2. Period 2: Treatment A: 24 mg ORMD-0801;(16 mg + 8 mg capsules) Once Daily (QD) at Bedtime 3. Period 3:Treatment B: 8 mg ORMD-0801; one 8 mg capsule three times a day (TID) 45-90 minutes before meals
Receives: Drug: ORMD-0801 Treatment A; Drug: ORMD-0801 Treatment B; Other: Placebo
Placebo then Treatment B then Treatment AExperimentalTreatment administered in the following order: 1. Period 1: Placebo (Fish Oil Capsule) 2. Period 2:Treatment B: 8 mg ORMD-0801; one 8 mg capsule three times a day (TID) 45-90 minutes before meals 3. Period 3: Treatment A: 24 mg ORMD-0801;(16 mg + 8 mg capsules) Once Daily (QD) at Bedtime Treatment B: 8 mg ORMD-0801; one 8 mg capsule three times a day (TID) 45-90 minutes before meals
Receives: Drug: ORMD-0801 Treatment A; Drug: ORMD-0801 Treatment B; Other: Placebo

What is being measured

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

  1. Average Exogenous Basal Insulin Compared to Baseline (Placebo)

    The least squares means difference of basal exogenous insulin between treatment A and placebo and treatment B and placebo, utilized over the final ten (10) days of each treatment period

    Measured: Combined Final ten days of each treatment period. Period1 (days -8 to 1)Period 2 (days 19 to 28) ,and Period 3 (days 47 to 56)

  2. Average Exogenous Bolus Insulin Compared to Baseline (Placebo)

    The amount of exogenous bolus insulin utilized over the final ten (10) days of each treatment period measured in mg/dL

    Measured: Combined Final ten days of treatment per treatment period (Days -8 to 1, Days 19 to 28, and Days 47 to 56)

  3. Average Exogenous Total Insulin Compared to Baseline

    The Least Squares Mean Difeerence ( (mg/dL) of total exogenous insulin (the sum of basal + bolus exogenous insulin) over the final ten (10) days of treatment.

    Measured: Combined Final ten days of treatment , day -8 to 1 (Period 1) Days 19 to 28 (Period 2), Days 47 to 56 (Period 3)

Secondary outcomes (3)

  1. Daytime Average Mean Glucose Compared to Baseline

    Least Squares Mean Difference from Baseline of Daytime Average Mean Glucose over the final ten (10) days of each treatment and each treatment period as measured by CGM.

    Measured: Combined Study days -8 to 1 (Period 1) Days 19 to 28 (Period 2), and days 47 to 56 (Period 3)

  2. Daytime Glucose Coefficient of Variation Compared to Baseline

    Least Squares Mean Continuous Glucose Monitor (CGM) Glucose Coefficient of Variation measured over daytime hours, compared to Baseline

    Measured: Study Days -8 to 1 (Period 1), Days 19-28 (Period 2), and Days 47-56 (Period 3)

  3. Daytime Low Blood Glucose Index (LBGI) Compared to Baseline

    Least Squares Mean Daytime Low Blood Glucose Index (LBGI) measured over the last ten (10) days of the treatment period, compared to Baseline LBGI is a clinical scale that indicates the probability for hypoglycemia. Blood Glucose Variability is an important measure because it provides additional clarification for HbA1c value.

    The risk of hypglycemic events and the LBGI scale is defined as follows:

    Minimal Risk ( LBGI < 1.1) Low Risk ( 1.1 < LBGI < 2.5) Moderate Risk (2.5 < LBGI < 5), HIgh Risk ( LBGI > 5)

    Measured: Combined Study Days -8 to 1 (Period 1), Days 19-28 (Period 2), and Days 47-56 (Period 3)

Timeline

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

  1. First posted4 Nov 2019
  2. Study start17 Oct 2019
  3. Primary completion6 Feb 2020
  4. Study completion12 Mar 2020

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
Crossover
Model description
This is an open-label crossover study in which all subjects will receive placebo run-in during Period 1 followed by Period 2, where subjects will be randomly assigned to either daily Treatment A (taken at Bedtime) and Treatment B (taken daily before each of three daily meals). At visit 5, the start of Period 3, subjects will stop their treatment (either A or B) and be CROSSED OVER to the other treatment (patients on treatment A during Period 2 will be crossed over to Treatment B and patients who were on Treatment B during Period 2 will be crossed over to Treatment A in Period 3).
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04150107
Sponsor's protocol ID
ORA-D-017
Status last verified
May 2022
First submitted
31 Oct 2019
Last updated
2 Jun 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ORMD-0801 Treatment A and ORMD-0801 Treatment B in people with Type 1 Diabetes, 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 15 inclusion and 28 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 2 Jun 2022. 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. 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 2 Jun 2022). 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?

Average Exogenous Basal Insulin Compared to Baseline (Placebo) (time frame: Combined Final ten days of each treatment period. Period1 (days -8 to 1)Period 2 (days 19 to 28) ,and Period 3 (days 47 to 56)). The study lists 3 primary outcomes in all. 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 NCT04150107.

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 2 Jun 2022.

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