T2DM (Type 2 Diabetes Mellitus)Phase 2NCT03467932
A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing Cohort A: ORMD-0801 and Cohort B: ORMD-0801 in people with T2DM (Type 2 Diabetes Mellitus), run by Oramed, Ltd. at 1 site in United States.
Trial summary
This is a four-way (Participant, Care Provider, Investigator, Outcomes Assessor) masked (blinded) study designed to explore the efficacy of ORMD-0801 when given in different regimens across a dose range for up to 12 weeks in subjects with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- Cohort A: ORMD-0801 and Cohort B: ORMD-0801
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 373 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2018to 18 Feb 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.
- Established diagnosis of T2DM for at least 6 months prior to Screening, with an HbA1C (glycated hemoglobin) ≥ 7.5%.
- Stable dose of metformin (at least 1500 mg or maximally tolerated dose)/oral antidiabetic (OAD) for a period of at least 3 months prior to screening.
- Taking metformin only or metformin in addition to no more than two of the following: DPP-4 (DiPeptidyl Peptidase-4), SGLT-2 (Sodium-GLucose coTransporter-2), or TZD (Thiazolidinediones).
- Body mass index (BMI) of up to 40 kg/m2 at Screening and stable weight, with no more than 5 kg gain or loss in the 3 months prior to Screening.
- Renal function - eGFR (estimated glomerular filtration rate) > 30 ml/min/1.73 m2
- Females of childbearing potential must have a negative serum pregnancy test result at Screening.
Who cannot join
- Subjects with insulin-dependent diabetes
- has a history of type 1 diabetes mellitus or a history of ketoacidosis, or subject is assessed by the investigator as possibly having type 1 diabetes mellitus confirmed by a C-peptide <0.7 ng/mL (0.23 nmol/L).
- has a history of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
- Treatment with glucosidase inhibitor, insulin secretagogues (other than sulfonylureas), glucagon-like peptide 1 (GLP-1) agonists within 3 months prior to Visit 1.
- History of any basal, pre-mix or prandial insulin (greater than 7 days) within 6 months prior to Screening.
- History of >2 episodes of severe hypoglycemia within 6 months prior to Screening.
Show all 36Show fewer
- History of hypoglycemic unawareness (episodes of severe hypoglycemia with seizure or requiring third-party intervention or documented low blood glucose without associated autonomic symptoms)
- Subjects with the following secondary complications of diabetes:
- Active proliferative retinopathy as confirmed by a dilated ophthalmoscopy/retinal photography examination performed (by a qualified person as per the country legislation) within 6 months prior to Screening.
- Renal dysfunction: eGFR < 30 ml/min/1.73 m2
- History of proliferative retinopathy or severe form of neuropathy or cardiac autonomic neuropathy (CAN)
- Uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 120 mmHg
- Presence of unstable angina or myocardial infarction within 6 months prior to Screening, Grade 3 or 4 congestive heart failure (CHF) according to the New York Heart Association (NYHA) criteria, valvular heart disease, cardiac arrhythmia requiring treatment, pulmonary hypertension, cardiac surgery, history/occurrence of coronary angioplasty and/or stroke or transient ischemic attack (TIA) within 6 months prior to Screening.
- Subjects with psychiatric disorders which, per investigator judgment may have an impact on the safety of the subject or interfere with the subject's participation or compliance in the study.
- Subjects who needed (in the last 12 months) or may require systemic (oral, intravenous, intramuscular) glucocorticoid therapy for more than 2 weeks during the study period.
- 9. Laboratory abnormalities at Screening include:
- C-peptide < 1.0 ng/mL
- 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 the study treatment administration.
- 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.
- Use of the following medications:
- History of any basal, pre-mix or prandial insulin (greater than 7 days) within 6 months prior to Screening.
- 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.
- 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), and immunosuppressive or immunomodulating agents.
- 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.
- Subject has had bariatric surgery.
- Subject is pregnant or breastfeeding.
- 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. 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.
- One or more contraindications to metformin as per local label.
- 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 factors that are deemed unsuitable for subject enrollment into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled, Multi-center, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of ORMD-0801 in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Therapy
This is a four-way (Participant, Care Provider, Investigator, Outcomes Assessor) masked (blinded) study designed to explore the efficacy of ORMD-0801 when given in different regimens across a dose range for up to 12 weeks in subjects with type 2 diabetes mellitus (T2DM).
Read the detailed description
This study is designed to explore the efficacy of ORMD-0801 when given in different regimens across a dose range for up to 12 weeks in subjects with type 2 diabetes mellitus (T2DM). There are two cohorts in this study. Approximately 360 subjects with T2DM will initially undergo a 2-week, single-blind placebo run-in period (Visits 1 and 2), followed by a 12-week treatment period (Visits 3 through 9). Cohort A will enroll 285 subjects; Cohort B will enroll 75 subjects
For 265 of the 285 subjects of Cohort A, the total 12-week treatment period will include a Part 1"dose escalation" interval (2 weeks, Visits 3 and 4) and a Part 2 stable dose "maintenance" interval (10 weeks, Visits 5 through 9).
In addition, per FDA request, the remaining 20 subjects (of the cohort total of 285 enrolled subjects) will receive excipient-matched placebo in a non-randomized single-blind fashion, TID (3 times per day), according to the same schedule as described above.
For Cohort B (75 of the 360 total subjects), the total 12-week treatment period will include a stable dosing period for both Part 1 (2 weeks, Visits 3 and 4) and Part 2 (10 weeks, Visits 5 through 9).
Cohort A data will be analyzed after Cohort A data collection has been completed (last subject for Cohort A screened on 7 May 2019). Estimated completion for Cohort A is October 2019. Cohort B data will be analyzed following the release of results from Cohort A.
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- Cohort A: ORMD-0801, Placebo oral capsule, Cohort B: ORMD-0801
- 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.
Cohort A: ORMD-0801Drug
Also called Oral Insulin
Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.
Part 2:
During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.
Placebo oral capsuleDrug
Also called SBTI, disodium EDTA, fish oil, aerosil, and TWEEN 80.
Placebo provided QHS, BID, TID
Cohort B: ORMD-0801Drug
Also called Oral Insulin
Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.
Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: ORMD-0801 once daily - QHS | Active comparator | Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Receives: Drug: Cohort A: ORMD-0801 |
| Cohort A: ORMD-0801 twice daily - BID | Active comparator | Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Receives: Drug: Cohort A: ORMD-0801 |
| Cohort A: ORMD-0801 three times daily - TID | Active comparator | ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch. Receives: Drug: Cohort A: ORMD-0801 |
| Cohort A: Matched Placebo Oral Capsule | Placebo comparator | Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID) Receives: Drug: Placebo oral capsule |
| Cohort A: Excipient-Matched Placebo three times daily-TID | Placebo comparator | Excipient matched placebo in a non-randomized single-blind fashion, TID, dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch.
This is an exploratory arm, per FDA. The results of this arm are not included in the primary analysis. Receives: Drug: Placebo oral capsule |
| Cohort B:ORMD-0801, 8 mg once daily - QHS: | Active comparator | ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Receives: Drug: Cohort B: ORMD-0801 |
| Cohort B: ORMD-0801 8 mg twice daily - BID | Active comparator | ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Receives: Drug: Cohort B: ORMD-0801 |
| Cohort B: ORMD-0801 16 mg once daily - QHS: | Active comparator | ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Receives: Drug: Cohort B: ORMD-0801 |
| Cohort B: ORMD-0801 16 mg twice daily - BID | Active comparator | ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Receives: Drug: Cohort B: ORMD-0801 |
| Cohort B - Matched Placebo Oral Capsule | Placebo comparator | Cohort B - Matched Placebo Oral Capsule: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline of HbA1C (Glycated Hemoglobin)
Least Squares Means change in HbA1C from baseline to Week 12 of the treatment period, where HbA1C is reported in units of percent. The change in HbA1c from baseline to Week 12 is expressed as a change in the value of HbA1C.
Measured: baseline (Run-in period, Week 0, Visit 1) and Week 12 (follow-up)
Secondary outcomes (2)
Mean Change From Baseline Over Time for HbA1C
Mean change from baseline (Run-In, Week 0 Visit 1) to Part 1, Visit 3 for HbA1C (measured in mmols/mol)
Measured: Baseline (Run-In:Week 0, Visit 1) to Part 1, Visit 3, elapsed time: 3 weeks.
Change Over Time in Hb1Ac
Change of Hb1Ac from Baseline to Week 10, measured in mmol/mol
Measured: Baseline (week 0, visit 1) to Week 10, part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start29 May 2018
- Primary completion21 Oct 2019
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oramed, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Responsible party
- Sponsor
- Investigators
- Joel M Neutel, M. D., Principal investigator, Orange County Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467932
- Sponsor's protocol ID
- ORA-D-015
- Status last verified
- Nov 2022
- First submitted
- 1 Mar 2018
- Last updated
- 8 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Multi-center, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of ORMD-0801 in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Therapy
- ClinicalTrials.gov ID
- NCT03467932
- Acronym / sponsor ID
- ORA-D-015
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Oramed, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Study start
- 29 May 2018 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Posted 8 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a four-way (Participant, Care Provider, Investigator, Outcomes Assessor) masked (blinded) study designed to explore the efficacy of ORMD-0801 when given in different regimens across a dose range for up to 12 weeks in subjects with type 2 diabetes mellitus (T2DM).
Detailed description
This study is designed to explore the efficacy of ORMD-0801 when given in different regimens across a dose range for up to 12 weeks in subjects with type 2 diabetes mellitus (T2DM). There are two cohorts in this study. Approximately 360 subjects with T2DM will initially undergo a 2-week, single-blind placebo run-in period (Visits 1 and 2), followed by a 12-week treatment period (Visits 3 through 9). Cohort A will enroll 285 subjects; Cohort B will enroll 75 subjects
For 265 of the 285 subjects of Cohort A, the total 12-week treatment period will include a Part 1"dose escalation" interval (2 weeks, Visits 3 and 4) and a Part 2 stable dose "maintenance" interval (10 weeks, Visits 5 through 9).
In addition, per FDA request, the remaining 20 subjects (of the cohort total of 285 enrolled subjects) will receive excipient-matched placebo in a non-randomized single-blind fashion, TID (3 times per day), according to the same schedule as described above.
For Cohort B (75 of the 360 total subjects), the total 12-week treatment period will include a stable dosing period for both Part 1 (2 weeks, Visits 3 and 4) and Part 2 (10 weeks, Visits 5 through 9).
Cohort A data will be analyzed after Cohort A data collection has been completed (last subject for Cohort A screened on 7 May 2019). Estimated completion for Cohort A is October 2019. Cohort B data will be analyzed following the release of results from Cohort A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort A: ORMD-0801 once daily - QHS | Active comparator | Drug: Cohort A: ORMD-0801Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) |
| Cohort A: ORMD-0801 twice daily - BID | Active comparator | Drug: Cohort A: ORMD-0801Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. |
| Cohort A: ORMD-0801 three times daily - TID | Active comparator | Drug: Cohort A: ORMD-0801ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch. |
| Cohort A: Matched Placebo Oral Capsule | Placebo comparator | Drug: Placebo oral capsulePlacebo matched to one of the three active comparator arms. (either QHS, BID, or TID) |
| Cohort A: Excipient-Matched Placebo three times daily-TID | Placebo comparator | Drug: Placebo oral capsuleExcipient matched placebo in a non-randomized single-blind fashion, TID, dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch. This is an exploratory arm, per FDA. The results of this arm are not included in the primary analysis. |
| Cohort B:ORMD-0801, 8 mg once daily - QHS: | Active comparator | Drug: Cohort B: ORMD-0801ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) |
| Cohort B: ORMD-0801 8 mg twice daily - BID | Active comparator | Drug: Cohort B: ORMD-0801ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. |
| Cohort B: ORMD-0801 16 mg once daily - QHS: | Active comparator | Drug: Cohort B: ORMD-0801ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) |
| Cohort B: ORMD-0801 16 mg twice daily - BID | Active comparator | Drug: Cohort B: ORMD-0801ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. |
| Cohort B - Matched Placebo Oral Capsule | Placebo comparator | Drug: Placebo oral capsuleCohort B - Matched Placebo Oral Capsule: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects aged 18 and older.
- Established diagnosis of T2DM for at least 6 months prior to Screening, with an HbA1C (glycated hemoglobin) ≥ 7.5%.
- Stable dose of metformin (at least 1500 mg or maximally tolerated dose)/oral antidiabetic (OAD) for a period of at least 3 months prior to screening.
- Taking metformin only or metformin in addition to no more than two of the following: DPP-4 (DiPeptidyl Peptidase-4), SGLT-2 (Sodium-GLucose coTransporter-2), or TZD (Thiazolidinediones).
- Body mass index (BMI) of up to 40 kg/m2 at Screening and stable weight, with no more than 5 kg gain or loss in the 3 months prior to Screening.
Key exclusion criteria (36 listed)
- Subjects with insulin-dependent diabetes
- Treatment with glucosidase inhibitor, insulin secretagogues (other than sulfonylureas), glucagon-like peptide 1 (GLP-1) agonists within 3 months prior to Visit 1.
- History of any basal, pre-mix or prandial insulin (greater than 7 days) within 6 months prior to Screening.
- History of >2 episodes of severe hypoglycemia within 6 months prior to Screening.
- History of hypoglycemic unawareness (episodes of severe hypoglycemia with seizure or requiring third-party intervention or documented low blood glucose without associated autonomic symptoms)
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 |
|---|---|---|
| Cohort A: ORMD-0801Also: Oral InsulinPart 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia. | Drug | Cohort A: ORMD-0801 once daily - QHS, Cohort A: ORMD-0801 three times daily - TID, Cohort A: ORMD-0801 twice daily - BID |
| Placebo oral capsuleAlso: SBTI, disodium EDTA, fish oil, aerosil, and TWEEN 80.Placebo provided QHS, BID, TID | Drug | Cohort A: Excipient-Matched Placebo three times daily-TID, Cohort A: Matched Placebo Oral Capsule, Cohort B - Matched Placebo Oral Capsule |
| Cohort B: ORMD-0801Also: Oral InsulinPart 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia. | Drug | Cohort B: ORMD-0801 16 mg once daily - QHS:, Cohort B: ORMD-0801 16 mg twice daily - BID, Cohort B: ORMD-0801 8 mg twice daily - BID, Cohort B:ORMD-0801, 8 mg once daily - QHS: |
Primary outcome
Change From Baseline of HbA1C (Glycated Hemoglobin)
Time frame: baseline (Run-in period, Week 0, Visit 1) and Week 12 (follow-up)
Least Squares Means change in HbA1C from baseline to Week 12 of the treatment period, where HbA1C is reported in units of percent. The change in HbA1c from baseline to Week 12 is expressed as a change in the value of HbA1C.
2 secondary outcomes
Mean Change From Baseline Over Time for HbA1C
Time frame: Baseline (Run-In:Week 0, Visit 1) to Part 1, Visit 3, elapsed time: 3 weeks.
Change Over Time in Hb1Ac
Time frame: Baseline (week 0, visit 1) to Week 10, part 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joel M Neutel, M. D. principal investigator
Orange County Research Center
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 Cohort A: ORMD-0801 and Cohort B: 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 7 inclusion and 36 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 8 Nov 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. 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 8 Nov 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?
Change From Baseline of HbA1C (Glycated Hemoglobin) (time frame: baseline (Run-in period, Week 0, Visit 1) and Week 12 (follow-up)). 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 8 Nov 2022.