Diabetes Mellitus, Type 2Phase 3NCT04817215
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 Diabetes Mellitus, Type 2, run by King Hamad University Hospital, Bahrain.
Trial summary
To compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1C in inadequately controlled T2DM subjects on diet control alone or on diet control and metformin monotherapy or two or three oral glucose-lowering agents. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- ORMD-0801
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 608 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Jul 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 18 - 75 years
- Established diagnosis of T2DM for at least 6 months prior to Screening AND an A1C ≥ 7.5% but ≤ 11.0% at Screening
- On a stable dose of at least two and up to three of the following oral glucose-lowering agents: Metformin, DPP-4 inhibitor, SGLT-2 inhibitor, thiazolidinedione, insulin secretagogue, or oral GLP-1 receptor agonists for a period of 3 months prior to Screening
- 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
- Renal function - eGFR ≥ 30 ml/min.
- Females of childbearing potential must:
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- have a negative serum pregnancy test result at Screening.
- 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.
- 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
- 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.
- 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
- Females who are not of childbearing potential are defined as:
- 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:
- Type 1 diabetes
- 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
- 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).
- Treatment involving glucosidase inhibitor, injected insulin, or injected GLP-1 receptor agonists (oral GLP-1 receptor antagonists are permitted), and pramlintide within 3 months prior to Visit 1.
- A history of >2 episodes of severe hypoglycemia within 6 months prior to Screening.
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- A history of hypoglycemic unawareness.
- 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.
- 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
- Renal dysfunction: eGFR < 30 mL/min
- A history of or active proliferative retinopathy requiring treatment
- 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
- Laboratory abnormalities at Screening including:
- C-peptide < 0.4 ng/mL
- 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
- Elevated liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)) >3X the upper limit of normal; a single repeat test is allowable
- Very elevated fasting 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
- Positive history of active liver disease (other than non-alcoholic hepatic steatosis), primary biliary cirrhosis, or active symptomatic gallbladder disease
- 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)
- 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
- Use of the following medications:
- History of use of any injectable or inhaled, basal, pre-mixed 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
- 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
- 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
- Known allergy to soy
- 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
- Prior bariatric surgery
- Subject 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. 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
- Any condition or other factor (at the Investigator's discretion) that is deemed unsuitable for subject enrollment into the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Double-Blinded, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Uncontrolled Type 2 DM Subjects on Diet Control Alone, Metformin Monotherapy, or Two or Three Oral Glucose-lowering Agents
To compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1C in inadequately controlled T2DM subjects on diet control alone or on diet control and metformin monotherapy or two or three oral glucose-lowering agents.
To assess the safety of repeat administration of ORMD-0801 in inadequately controlled T2DM subjects on on diet control alone or on diet control and metformin monotherapy or two or three oral glucose-lowering agents.
Read the detailed description
In this randomized, double-blind, double dummy, placebo-controlled study, approximately 608 eligible subjects with type 2 diabetes and inadequate control on diet control alone or on diet control and metformin monotherapy or on at least two and up to 3 oral glucose-lowering agents will undergo an initial 21-day Screening Period, followed by a 6 month Double-Blind Treatment Period and a 6 month Double-Blind Treatment Extension Period.
Screening Period:
The Investigator will review the aim of the study, study procedures and potential risks and benefits. These subjects will then sign a written informed consent during the Screening Visit 1. They will be scheduled to return to the clinic 10 days prior to randomization for Screening Visit 2. At this visit, a CGM sensor will be placed with appropriate instructions by the study team for a 10-day blinded continuous glucose monitoring (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 arms of the study treatment.
6 month Double-Blind Treatment Period: After the Screening Period, subjects will be randomized to 6 months of the Double-Blind Treatment Period. In a double-blind, double dummy randomization scheme, subjects will either receive ORMD-0801 administered once-daily at night (1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner) or ORMD-0801 8 mg (1 x 8 mg capsule) administered twice daily, each morning approximately 45 minutes (±15 minutes) prior to breakfast and each night prior to bedtime (between 8 PM to 12 Midnight and no sooner than 1 hour after dinner); or matching placebo. Subjects will receive 1 capsule approximately 45 minutes (±15 minutes) prior to breakfast and 1 capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner.
During the Double-Blind Treatment Period commencing at Week 0 (Visit 1, CGM removal), subjects will return to the clinic every six weeks.
The visit requiring CGM application will occur 10 days prior to the CGM removal visit within ± 1-day window.
6-Month Double-Blind Treatment Extension Period: Following the completion of the Double-Blind Treatment Period, subject will enter a 6-month Double-Blind Treatment Extension Period. Subjects previously randomized to placebo during the Double-Blind Treatment Period will be randomized to receive either ORMD-0801 8 mg QD or 8 mg BID for the duration of the Double-Blind Treatment Extension Period. Subjects previously randomized to 8 mg QD or 8 mg BID during the Double-Blind Treatment Period will remain in the same treatment arm 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 6-month Double-Blind Treatment: every six weeks. Extension Period: also every six weeks until the last visit (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 ± 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 lost to follow up and missing data.
Throughout the course of the study, subjects will measure and record fasting blood glucose levels at least 2-3 times a week [self-monitored blood glucose (SMBG)] or when they experience any symptoms of hypoglycemia using a glucose meter. Subjects will be provided a paper diary at each clinic visit and trained to record information related to fasting blood glucose and description of hypoglycemic events: time and date of occurrence; symptoms experienced, if any; treatment given, if any; and specific circumstances. Subjects will be required to bring the paper diary at each clinic visit where data will be reviewed.
Rescue Visits and Medication:
During both the Double-Blind Treatment Period and Double-Blind Treatment Extension Period, background oral glucose-lowering dose regimens will be maintained, and further dose adjustments are discouraged unless clinically indicated as follows:
Subjects will be eligible for rescue based on the following glycemic criteria:
- From Day 1 (Visit 1) through Week 6 (Visit 2), if at least two fasting SMBG levels are > 270 mg/dL in the week preceding a visit are confirmed by a single central laboratory fasting glucose > 270 mg/dL.
- From Week 6 (Visit 2) through Week 12 (Visit 3), if at least two fasting SMBG levels are > 240 mg/dL in the week preceding a visit are confirmed by a single central laboratory fasting glucose > 240 mg/dL.
- From Week 12 (Visit 3) through Week 26 (Visit 6), if at least two fasting SMBG levels are > 220 mg/dL in the week preceding a visit are confirmed by a single central laboratory fasting glucose > 220 mg/dL.
- From Week 26 (Visit 6) through the end of the study, if at least two fasting SMBG levels are > 200 mg/dL in the week preceding a visit are confirmed by a single central laboratory fasting glucose > 200 mg/dL.
Rescue will allow subjects to remain in the study, remain on double-blind study medication, complete all visits until the end of the study, and thereby, contribute to exposure and safety data. Rescue medication will be prescribed in accordance with the study Investigator's usual standard of practice.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- 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.
ORMD-0801Drug
Randomized to receive ORMD-0801 8 mg QD or 8 mg BID or matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Patients who are Drug naïve or diet controlled | Experimental | Not described Receives: Drug: ORMD-0801 |
| Patients on Metformin only | Experimental | Not described Receives: Drug: ORMD-0801 |
| Patients on two or three oral glucose-lowering agents | Experimental | Not described Receives: Drug: ORMD-0801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline (Visit 1) in A1C at 26 weeks
- Means and mean changes from baseline over time for A1C and FPG during the Double-Blind Treatment Period and the Double-Blind Treatment Extension Period.
Measured: 6 months with follow-up extension for additional six months
Secondary outcomes (1)
Safety of repeat administration of ORMD-0801 in inadequately controlled T2DM subjects
- Safety assessed by adverse event reporting including adverse events of special interest such as hypoglycemia.
Measured: 6 months with follow-up extension for additional six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study startOct 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 608 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Hamad University Hospital, Bahrain
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Surgeons in Ireland - Medical University of Bahrain, Oramed, Ltd.
- Responsible party
- Sponsor
- Investigators
- Dr. Dalal Alromaihi, Principal investigator, King Hamad University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817215
- Sponsor's protocol ID
- ORMD-0801-KHUH
- Status last verified
- Mar 2021
- First submitted
- 7 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Uncontrolled Type 2 DM Subjects on Diet Control Alone, Metformin Monotherapy, or Two or Three Oral Glucose-lowering Agents
- ClinicalTrials.gov ID
- NCT04817215
- Acronym / sponsor ID
- ORMD-0801-KHUH
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 608 participants (estimated)
- Lead sponsor
- King Hamad University Hospital, BahrainUniversity, hospital or other
- Collaborators
- Royal College of Surgeons in Ireland - Medical University of Bahrain, Oramed, Ltd.
- Study start
- Oct 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 26 Mar 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.
To compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1C in inadequately controlled T2DM subjects on diet control alone or on diet control and metformin monotherapy or two or three oral glucose-lowering agents.
To assess the safety of repeat administration of ORMD-0801 in inadequately controlled T2DM subjects on on diet control alone or on diet control and metformin monotherapy or two or three oral glucose-lowering agents.
Detailed description
In this randomized, double-blind, double dummy, placebo-controlled study, approximately 608 eligible subjects with type 2 diabetes and inadequate control on diet control alone or on diet control and metformin monotherapy or on at least two and up to 3 oral glucose-lowering agents will undergo an initial 21-day Screening Period, followed by a 6 month Double-Blind Treatment Period and a 6 month Double-Blind Treatment Extension Period.
Screening Period:
The Investigator will review the aim of the study, study procedures and potential risks and benefits. These subjects will then sign a written informed consent during the Screening Visit 1. They will be scheduled to return to the clinic 10 days prior to randomization for Screening Visit 2. At this visit, a CGM sensor will be placed with appropriate instructions by the study team for a 10-day blinded continuous glucose monitoring (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 arms of the study treatment.
6 month Double-Blind Treatment Period: After the Screening Period, subjects will be randomized to 6 months of the Double-Blind Treatment Period. In a double-blind, double dummy randomization scheme, subjects will either receive ORMD-0801 administered once-daily at night (1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner) or ORMD-0801 8 mg (1 x 8 mg capsule) administered twice daily, each morning approximately 45 minutes (±15 minutes) prior to breakfast and each night prior to bedtime (between 8 PM to 12 Midnight and no sooner than 1 hour after dinner); or matching placebo. Subjects will receive 1 capsule approximately 45 minutes (±15 minutes) prior to breakfast and 1 capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner.
During the Double-Blind Treatment Period commencing at Week 0 (Visit 1, CGM removal), subjects will return to the clinic every six weeks.
The visit requiring CGM application will occur 10 days prior to the CGM removal visit within ± 1-day window.
6-Month Double-Blind Treatment Extension Period: Following the completion of the Double-Blind Treatment Period, subject will enter a 6-month Double-Blind Treatment Extension Period. Subjects previously randomized to placebo during the Double-Blind Treatment Period will be randomized to receive either ORMD-0801 8 mg QD or 8 mg BID for the duration of the Double-Blind Treatment Extension Period. Subjects previously randomized to 8 mg QD or 8 mg BID during the Double-Blind Treatment Period will remain in the same treatment arm 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 6-month Double-Blind Treatment: every six weeks. Extension Period: also every six weeks until the last visit (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 ± 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 lost to follow up and missing data.
Throughout the course of the study, subjects will measure and record fasting blood glucose levels at least 2-3 times a week [self-monitored blood glucose (SMBG)] or when they experience any symptoms of hypoglycemia using a glucose meter. Subjects will be provided a paper diary at each clinic visit and trained to record information related to fasting blood glucose and description of hypoglycemic events: time and date of occurrence; symptoms experienced, if any; treatment given, if any; and specific circumstances. Subjects will be required to bring the paper diary at each clinic visit where data will be reviewed.
Rescue Visits and Medication:
During both the Double-Blind Treatment Period and Double-Blind Treatment Extension Period, background oral glucose-lowering dose regimens will be maintained, and further dose adjustments are discouraged unless clinically indicated as follows:
Subjects will be eligible for rescue based on the following glycemic criteria:
- From Day 1 (Visit 1) through Week 6 (Visit 2), if at least two fasting SMBG levels are > 270 mg/dL in the week preceding a visit are confirmed by a single central laboratory fasting glucose > 270 mg/dL.
- From Week 6 (Visit 2) through Week 12 (Visit 3), if at least two fasting SMBG levels are > 240 mg/dL in the week preceding a visit are confirmed by a single central laboratory fasting glucose > 240 mg/dL.
- From Week 12 (Visit 3) through Week 26 (Visit 6), if at least two fasting SMBG levels are > 220 mg/dL in the week preceding a visit are confirmed by a single central laboratory fasting glucose > 220 mg/dL.
- From Week 26 (Visit 6) through the end of the study, if at least two fasting SMBG levels are > 200 mg/dL in the week preceding a visit are confirmed by a single central laboratory fasting glucose > 200 mg/dL.
Rescue will allow subjects to remain in the study, remain on double-blind study medication, complete all visits until the end of the study, and thereby, contribute to exposure and safety data. Rescue medication will be prescribed in accordance with the study Investigator's usual standard of practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients who are Drug naïve or diet controlled | Experimental | Drug: ORMD-0801 |
| Patients on Metformin only | Experimental | Drug: ORMD-0801 |
| Patients on two or three oral glucose-lowering agents | Experimental | Drug: ORMD-0801 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male and female subjects aged 18 - 75 years
- Established diagnosis of T2DM for at least 6 months prior to Screening AND an A1C ≥ 7.5% but ≤ 11.0% at Screening
- On a stable dose of at least two and up to three of the following oral glucose-lowering agents: Metformin, DPP-4 inhibitor, SGLT-2 inhibitor, thiazolidinedione, insulin secretagogue, or oral GLP-1 receptor agonists for a period of 3 months prior to Screening
- 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
- Renal function - eGFR ≥ 30 ml/min.
Key exclusion criteria (32 listed)
- Type 1 diabetes
- 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
- 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).
- Treatment involving glucosidase inhibitor, injected insulin, or injected GLP-1 receptor agonists (oral GLP-1 receptor antagonists are permitted), and pramlintide within 3 months prior to Visit 1.
- A history of >2 episodes of severe hypoglycemia within 6 months prior to Screening.
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-0801Randomized to receive ORMD-0801 8 mg QD or 8 mg BID or matching placebo | Drug | Patients on Metformin only, Patients on two or three oral glucose-lowering agents, Patients who are Drug naïve or diet controlled |
Primary outcome
Mean change from baseline (Visit 1) in A1C at 26 weeks
Time frame: 6 months with follow-up extension for additional six months
• Means and mean changes from baseline over time for A1C and FPG during the Double-Blind Treatment Period and the Double-Blind Treatment Extension Period.
1 secondary outcome
Safety of repeat administration of ORMD-0801 in inadequately controlled T2DM subjects
Time frame: 6 months with follow-up extension for additional six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
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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.
Dr. Dalal Alromaihi principal investigator
King Hamad University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ORMD-0801 in people with Diabetes Mellitus, Type 2, run by King Hamad University Hospital, Bahrain.
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 13 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Dalal Alromaihi (97339907906, dalal.alromaihi@khuh.org.bh), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline (Visit 1) in A1C at 26 weeks (time frame: 6 months with follow-up extension for additional six months). 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 26 Mar 2021.