T2DM (Type 2 Diabetes Mellitus)Phase 3NCT04754334
A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus
A Phase 3 study testing ORMD-0801 in people with T2DM (Type 2 Diabetes Mellitus), run by Oramed, Ltd. at 1 site in United States.
Trial summary
This double-masked placebo-controlled study will include approximately 450 subjects with inadequately controlled T2DM on diet control alone or on diet control and metformin monotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- ORMD-0801
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 346 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 13 Jan 2023
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Established diagnosis of T2DM for at least 6 months prior to Screening AND an A1C ≥ 7.5% but ≤ 11.0% at Screening.
- 2. Subjects should be on:
- a. Diet and exercise therapy with no oral or injectable glucose lowering therapy for a period of at least 3 months prior to screening; OR
- b. Diet and exercise therapy with a stable dose of metformin only (≥1500 mg or maximal tolerated dose) for a period of at least 3 months prior to Screening.
- 3. Body mass index (BMI) of 25-40 kg/m2 at Screening and stable weight, with no more than 5 kg gain or loss in the 3 months prior to Screening.
- 4. Renal function - GFR ≥ 30 ml/min/1.73 m2.
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- 5. Females of childbearing potential must:
- a. have a negative serum pregnancy test result at Screening.
- b. agree to avoid becoming pregnant while receiving IP for at least 30 days prior to IP administration, during the entire study, and for 30 days following their last dose of IP.
- c. agree to use an acceptable method of contraception at least 30 days prior to IP administration, during the entire study, and for 30 days following their last dose of IP. Acceptable methods of contraception are hormonal contraception (contraceptive pill or injection) PLUS an additional barrier method of contraception such as a diaphragm, condom, sponge, or spermicide.
- d. In the absence of hormonal contraception, double-barrier methods must be used which include a combination of any two of the following: diaphragm, condom, copper intrauterine device, sponge, or spermicide, and must be used for at least 30 days prior to administration of IP, during the entire study, and for 30 days following their last dose of IP.
- e. Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ERCs/IRBs. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.
- f. Females who are not of childbearing potential are defined as:
- i. Postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age); OR
- ii. Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR
- iii. Have a congenital or acquired condition that prevents childbearing.
Who cannot join
- Subjects with:
- 1. Type 1 diabetes.
- 2. A history of diabetes mellitus with ketoacidosis or is assessed by the Investigator as possibly having type 1 diabetes mellitus confirmed by a C-peptide < 0.4 ng/mL (0.13 nmol/L) at Screening.
- 3. Diabetes attributable to other secondary causes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
- 4. Concomitant treatment involving insulin, and any other inhaled, oral or injectable antihyperglycemic agents including alpha glucosidase inhibitor, meglitinides, sulfonylurea, DPP-4 inhibitor, SGLT-2 inhibitor, thiazolidinedione or GLP-1 agonists, and pramlintide within 2 months prior to Visit 1.
- 5. A history of >2 episodes of severe hypoglycemia within 6 months prior to Screening.
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- 6. A history of hypoglycemic unawareness.
- 7. A history of unstable angina or myocardial infarction within 6 months prior to Screening, New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure (CHF), valvular heart disease, ventricular cardiac arrhythmia requiring treatment, pulmonary hypertension, cardiac surgery, coronary angioplasty, stroke or transient ischemic attack (TIA) within 6 months prior to Screening.
- 8. A history of uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg. A single repeat measurement will be permitted.
- 9. Renal dysfunction: GFR < 30 mL/min/1.73 m2.
- 10. Active proliferative retinopathy requiring treatment.
- 11. Psychiatric disorders that, per Investigator judgment, may have impact on the safety of the subject or interfere with subject's participation or compliance in the study.
- 12. Laboratory abnormalities at Screening including:
- a. C-peptide < 0.4 ng/mL.
- b. Abnormal serum thyrotropin (TSH) levels below the lower limit of normal or >1.5X the upper limit of normal; a single repeat test is allowable.
- c. Elevated liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)) >3X the upper limit of normal; a single repeat test is allowable.
- d. Very high fasting triglyceride levels (>600 mg/dL); a single repeat test is allowable.
- e. Any relevant abnormality that would interfere with the efficacy or the safety assessments during study treatment administration.
- 13. Positive history of active liver disease (other than non-alcoholic hepatic steatosis), primary biliary cirrhosis, or active symptomatic gallbladder disease.
- 14. Positive results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus ribonucleic acid (RNA).
- 15. Patient has active or history of neoplastic disease (except for adequately treated non-invasive basal cell and/or squamous cell carcinoma or carcinoma in situ of the cervix) within the past 5 years prior to Baseline.
- 16. Use of the following medications:
- a. History of use of any injectable or inhaled, basal, pre-mixed or prandial insulin (greater than 7 days) within 6 months prior to Screening.
- b. Administration of thyroid preparations or thyroxine (except in subjects on stable replacement therapy) within 6 weeks prior to Screening.
- c. Requirements (in the last 12 months), or may require, systemic (oral, intravenous, intramuscular) glucocorticoid therapy for more than 2 weeks during the study period. Intra-articular and/or topical corticosteroids are not considered systemic.
- d. Use of medications known to modify glucose metabolism or to decrease the ability to recover from hypoglycemia such as oral, parenteral, and immunosuppressive or immunomodulating agents. Inhaled nasal steroids are permissible.
- 17. Known allergy to soy.
- 18. Involvement in a weight loss program and is not in the maintenance phase, or subject has started weight loss medication (e.g., orlistat or liraglutide) within 3 months prior to Screening.
- 19. Prior bariatric surgery.
- 20. Subject is pregnant or breast-feeding.
- 21. 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 Oramed Ltd. Protocol No. ORA-D-013-2 Phase 3 Clinical Study October 12, 2020 Page 12 alcohol intake as defined by >3 drinks per day or >14 drinks per week or binge drinking) at Screening. Occasional intermittent use of cannabinoid products will be allowed provided that no cannabinoid products have been used during the 1 week prior to each visit.
- 22. Contraindications to metformin use as per label.
- 23. A history of gastrointestinal disorders (e.g. hypochlorhydria) with the potential to interfere with drug absorption.
- 24. Any condition or other factor (at the Investigator's discretion) that is deemed unsuitable for subject enrollment into the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Research Institute of South Florida, Inc. (PHARMASEEK)
Coral Gables, Florida, 33124
About this study
Official title: A Double-Blind, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in T2DM Subjects With Inadequate Glycemic Control on Diet Control Only or on Diet Control and Metformin Monotherapy.
This double-masked placebo-controlled study will include approximately 450 subjects with inadequately controlled T2DM on diet control alone or on diet control and metformin monotherapy. Subjects will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a Double-Blind 26-week Treatment Extension Period.
Read the detailed description
Screening Period The investigator will review the aim of the study, study procedures, potential risks, and benefits with the volunteers. These subjects will then sign a written informed consent during Screening Visit 1. They will be instructed to return to the clinic 10 days prior to randomization (Visit 1) for Screening Visit 2. At this visit, a continuous glucose monitoring (CGM) sensor will be placed with appropriate instructions by the study team for a 10-day blinded CGM data collection by the site. Subjects will then return to the clinic after 10 days (± 1-day) for removal of the CGM sensor. The subjects will be randomized to one of the three study treatment arms.
26-Week Double-Masked Treatment Period After the Screening Period, subjects will be randomized to 26 weeks of the Double-Blind Treatment Period consisting of ORMD-0801 8 mg (1 x 8 mg capsule), or placebo in a 1:1 randomized fashion. Medication will be administered once daily at night prior to bedtime (between 8 PM to 12 Midnight and no sooner than 1 hour after dinner).
During the Double-Masked Treatment Period commencing at Week 0 (Visit 1, CGM removal), subjects will return to the clinic at the following intervals: Week 6 - Visit 2; Week 12 -Visit 3; Week 18 - Visit 4; Week 24 - Visit 5 (10 days prior to Week 26 for CGM application) and Week 26 - Visit 6 (CGM removal and end of Double-Blind Treatment Period visit).
The visit requiring CGM application will occur 10 days prior to the CGM removal visit within a ± 1-day window
26-Week Double-Masked Treatment Extension Period Following the completion of the Double-Blind Treatment Period, subjects will enter a 26-week Double-Blind Treatment Extension Period. Subjects will remain on the same treatment regimen and continue to receive the same medication for the duration of the Double-Blind Treatment Extension Period. The Extension Period treatment assignments will remain blinded for the duration of the study.
Visits will occur at the following intervals during the 26-Week Double-Masked Treatment Extension Period: Week 30 - (Visit 7); Week 40 - Visit 8; Week 50 - Visit 9 (10 days prior to Week 52 for CGM application); and Week 52 - Visit 10 (CGM removal and end of Double-Blind Treatment Extension Period visit).
The visit requiring CGM application will occur 10 days prior to the CGM removal visit within a ± 1-day window.
All subjects completing the trial will return to the clinic in 2 weeks ± 3 days for a Safety Follow-Up Visit. Subjects withdrawing prematurely from the trial, will have the early termination (ET) visit procedures completed. All patients will continue to be followed in accordance with ITT principles to avoid a loss to follow-up and missing data.
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- ORMD-0801, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORMD-0801Drug
Also called Oral Insulin
Oral Insulin
PlaceboOther
Also called Fish Oil
Fish Oil
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo dosed QD Receives: Other: Placebo |
| ORMD-0801 | Experimental | ORMD-0801 8 mg QD Receives: Drug: ORMD-0801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in A1C
mean change from baseline (Visit 1) in A1C at 26 weeks (Visit 6) for the active and placebo groups. Randomization will occur at Visit 1 (Week 0),
Measured: Baseline and Week 26
Secondary outcomes (1)
The mean change in fasting plasma glucose
The mean change from baseline (Visit 1) in fasting plasma glucose at 26 weeks (Visit 6)
Measured: baseline and week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start16 Mar 2021
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Why it stopped: The ORA-D-013-2 protocol was terminated based on the primary results analyzed at week 26 in the ORA-D-013-1 protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Approximately 450 US- and Europe-based adult male and female subjects with T2DM will be randomized in a 1:1 ratio to receive either ORMD-0801 8 mg QD (one 8 mg capsule, dosed at night), or placebo dosed QD (dosed at night). It is anticipated that 225 subjects will be randomized to each arm of the study to complete approximately 200 subjects in each arm.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oramed, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Responsible party
- Sponsor
- Investigators
- Miriam Kidron, PhD, Study chair, Oramed, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754334
- Sponsor's protocol ID
- ORA-D-013-2
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2021
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in T2DM Subjects With Inadequate Glycemic Control on Diet Control Only or on Diet Control and Metformin Monotherapy.
- ClinicalTrials.gov ID
- NCT04754334
- Acronym / sponsor ID
- ORA-D-013-2
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The ORA-D-013-2 protocol was terminated based on the primary results analyzed at week 26 in the ORA-D-013-1 protocol.
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Oramed, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 15 Feb 2021 (actual)
- 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.
This double-masked placebo-controlled study will include approximately 450 subjects with inadequately controlled T2DM on diet control alone or on diet control and metformin monotherapy. Subjects will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a Double-Blind 26-week Treatment Extension Period.
Detailed description
Screening Period The investigator will review the aim of the study, study procedures, potential risks, and benefits with the volunteers. These subjects will then sign a written informed consent during Screening Visit 1. They will be instructed to return to the clinic 10 days prior to randomization (Visit 1) for Screening Visit 2. At this visit, a continuous glucose monitoring (CGM) sensor will be placed with appropriate instructions by the study team for a 10-day blinded CGM data collection by the site. Subjects will then return to the clinic after 10 days (± 1-day) for removal of the CGM sensor. The subjects will be randomized to one of the three study treatment arms.
26-Week Double-Masked Treatment Period After the Screening Period, subjects will be randomized to 26 weeks of the Double-Blind Treatment Period consisting of ORMD-0801 8 mg (1 x 8 mg capsule), or placebo in a 1:1 randomized fashion. Medication will be administered once daily at night prior to bedtime (between 8 PM to 12 Midnight and no sooner than 1 hour after dinner).
During the Double-Masked Treatment Period commencing at Week 0 (Visit 1, CGM removal), subjects will return to the clinic at the following intervals: Week 6 - Visit 2; Week 12 -Visit 3; Week 18 - Visit 4; Week 24 - Visit 5 (10 days prior to Week 26 for CGM application) and Week 26 - Visit 6 (CGM removal and end of Double-Blind Treatment Period visit).
The visit requiring CGM application will occur 10 days prior to the CGM removal visit within a ± 1-day window
26-Week Double-Masked Treatment Extension Period Following the completion of the Double-Blind Treatment Period, subjects will enter a 26-week Double-Blind Treatment Extension Period. Subjects will remain on the same treatment regimen and continue to receive the same medication for the duration of the Double-Blind Treatment Extension Period. The Extension Period treatment assignments will remain blinded for the duration of the study.
Visits will occur at the following intervals during the 26-Week Double-Masked Treatment Extension Period: Week 30 - (Visit 7); Week 40 - Visit 8; Week 50 - Visit 9 (10 days prior to Week 52 for CGM application); and Week 52 - Visit 10 (CGM removal and end of Double-Blind Treatment Extension Period visit).
The visit requiring CGM application will occur 10 days prior to the CGM removal visit within a ± 1-day window.
All subjects completing the trial will return to the clinic in 2 weeks ± 3 days for a Safety Follow-Up Visit. Subjects withdrawing prematurely from the trial, will have the early termination (ET) visit procedures completed. All patients will continue to be followed in accordance with ITT principles to avoid a loss to follow-up and missing data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Approximately 450 US- and Europe-based adult male and female subjects with T2DM will be randomized in a 1:1 ratio to receive either ORMD-0801 8 mg QD (one 8 mg capsule, dosed at night), or placebo dosed QD (dosed at night). It is anticipated that 225 subjects will be randomized to each arm of the study to complete approximately 200 subjects in each arm.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placeboplacebo dosed QD |
| ORMD-0801 | Experimental | Drug: ORMD-0801ORMD-0801 8 mg QD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1. Established diagnosis of T2DM for at least 6 months prior to Screening AND an A1C ≥ 7.5% but ≤ 11.0% at Screening.
- 2. Subjects should be on:
- 3. Body mass index (BMI) of 25-40 kg/m2 at Screening and stable weight, with no more than 5 kg gain or loss in the 3 months prior to Screening.
- 4. Renal function - GFR ≥ 30 ml/min/1.73 m2.
- 5. Females of childbearing potential must:
Key exclusion criteria (34 listed)
- Subjects with:
- 1. Type 1 diabetes.
- 2. A history of diabetes mellitus with ketoacidosis or is assessed by the Investigator as possibly having type 1 diabetes mellitus confirmed by a C-peptide < 0.4 ng/mL (0.13 nmol/L) at Screening.
- 3. Diabetes attributable to other secondary causes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
- 4. Concomitant treatment involving insulin, and any other inhaled, oral or injectable antihyperglycemic agents including alpha glucosidase inhibitor, meglitinides, sulfonylurea, DPP-4 inhibitor, SGLT-2 inhibitor, thiazolidinedione or GLP-1 agonists, and pramlintide within 2 months prior to Visit 1.
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-0801Also: Oral InsulinOral Insulin | Drug | ORMD-0801 |
| PlaceboAlso: Fish OilFish Oil | Other | Placebo |
Primary outcome
Mean change in A1C
Time frame: Baseline and Week 26
mean change from baseline (Visit 1) in A1C at 26 weeks (Visit 6) for the active and placebo groups. Randomization will occur at Visit 1 (Week 0),
1 secondary outcome
The mean change in fasting plasma glucose
Time frame: baseline and week 26
Results and safety
The study was stopped early (reason given: The ORA-D-013-2 protocol was terminated based on the primary results analyzed at week 26 in the ORA-D-013-1 protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Miriam Kidron, PhD study chair
Oramed, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ORMD-0801 in people with T2DM (Type 2 Diabetes Mellitus), 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 16 inclusion and 34 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: stopped early, as of the sponsor's last update on 9 Feb 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: The ORA-D-013-2 protocol was terminated based on the primary results analyzed at week 26 in the ORA-D-013-1 protocol.). Results are not available in the source record.
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?
Mean change in A1C (time frame: Baseline and Week 26). 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 9 Feb 2023.