A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus.
NCT ID: NCT06731075
Last Updated: 2025-08-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE3
Total Enrollment
300 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-12-15
Study Completion Date
2027-05-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
ORA-013-3 is a randomized, controlled study to test the efficacy and safety of an oral capsule of ORMD-0801 at several doses in patients with Type 2 Diabetes Mellitus (T2DM) who have not responded well to other glucose-lowering medications. A total of three hundred subjects will be enrolled in this study and will be required to complete this thirty-four-week clinical trial.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus
NCT04606576
Type 2 Diabetes Mellitus
TERMINATED
PHASE3
A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus
NCT04754334
T2DM (Type 2 Diabetes Mellitus)
TERMINATED
PHASE3
A Study to Evaluate the Effect of ORMD-0801 in Patients With Type 2 Diabetes Mellitus
NCT04564846
Diabetes Mellitus, Type 2
COMPLETED
PHASE2
Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus (T2DM)
NCT01889667
Diabetes Mellitus Type 2
COMPLETED
PHASE2
Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus
NCT02496000
Diabetes Type 2
COMPLETED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In this randomized, double-blind, double dummy, placebo-controlled study, approximately 300 eligible subjects with T2DM and inadequate control on at least one to three glucose-lowering agents will undergo an initial 4-week Screening Period. This will be followed by a 26-week Double-Blind Treatment Period, commencing with a safety Follow-up Visit four weeks after the completion of the trial. Analysis for the primary and secondary endpoints will be provided for the following subgroups of baseline factors:
1. Sex (Male, Female)
2. Age Group (60 years and younger, over 60 years)
3. Baseline A1C (Less than or equal to 9.0, Greater than 9.0)
4. Race
5. Ethnicity
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 (Screen 1) following which various study procedures will be performed (refer to Table 2). They will be scheduled to return to the clinic 10 days prior to randomization for Screening Visit 2 (Screen 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 four arms of the study treatment.
Treatment Period
After the Screening Period, subjects will be randomized to 26 weeks of Double-Blind Treatment.
In a double-blind, double dummy randomization scheme, subjects will be randomized to one of the following four treatment arms:
1. ORMD-0801 8 mg once-daily at night - QD: 1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 2 placebo capsules (1 in the morning and 1 at night).
2. ORMD-0801 8 mg twice daily - BID: 1 x 8 mg capsule each morning approximately 45 minutes (±15 minutes) prior to breakfast and 1 x 8 mg capsule each night prior to bedtime (between 8 PM to 12 Midnight and no sooner than 1 hour after dinner) and 1 placebo capsule at night.
3. ORMD-0801 16 mg once-daily at night - QD: 2 x 8 mg capsules between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 1 placebo capsule in the morning.
4. Placebo. During the Double-Blind Treatment Period commencing at Week 0 (Visit 1, CGM removal), subjects will return to the clinic at 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 ± 1-day window.
Safety Follow-up/End of Study All subjects completing the trial will return to the clinic in 4 weeks ± 3 days for a safety Follow-up Visit. Study procedures and assessments will be performed.
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.
1. Sex (Male, Female)
2. Age Group (60 years and younger, over 60 years)
3. Baseline A1C (Less than or equal to 9.0, Greater than 9.0)
4. Race
5. Ethnicity
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 (Screen 1) following which various study procedures will be performed (refer to Table 2). They will be scheduled to return to the clinic 10 days prior to randomization for Screening Visit 2 (Screen 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 four arms of the study treatment.
Treatment Period
After the Screening Period, subjects will be randomized to 26 weeks of Double-Blind Treatment.
In a double-blind, double dummy randomization scheme, subjects will be randomized to one of the following four treatment arms:
1. ORMD-0801 8 mg once-daily at night - QD: 1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 2 placebo capsules (1 in the morning and 1 at night).
2. ORMD-0801 8 mg twice daily - BID: 1 x 8 mg capsule each morning approximately 45 minutes (±15 minutes) prior to breakfast and 1 x 8 mg capsule each night prior to bedtime (between 8 PM to 12 Midnight and no sooner than 1 hour after dinner) and 1 placebo capsule at night.
3. ORMD-0801 16 mg once-daily at night - QD: 2 x 8 mg capsules between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 1 placebo capsule in the morning.
4. Placebo. During the Double-Blind Treatment Period commencing at Week 0 (Visit 1, CGM removal), subjects will return to the clinic at 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 ± 1-day window.
Safety Follow-up/End of Study All subjects completing the trial will return to the clinic in 4 weeks ± 3 days for a safety Follow-up Visit. Study procedures and assessments will be performed.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Type 2 Diabetes Mellitus
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
In this randomized, double-blind, double dummy, placebo-controlled study, approximately 300 eligible subjects with T2DM and inadequate control on at least one to three glucose-lowering agents will undergo an initial 4-week Screening Period. This will be followed by a 26-week Double-Blind Treatment Period, commencing with a safety Follow-up Visit four weeks after the completion of the trial.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Sponsor, Contract Reserarch Organization and Medical Laboratories.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ORMD-0801 8 mg once-daily at night - QD
Double-Dummy; the subject receives both experimental drug and placebo. 1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 2 placebo capsules (1 in the morning and 1 at night).
Group Type
ACTIVE_COMPARATOR
ORMD-0801 8 mg
Intervention Type
DRUG
1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 2 placebo capsules (1 in the morning and 1 at night).
Placebo capsule
Intervention Type
OTHER
Placebo capsule
ORMD-0801 8 mg twice daily - BID
Double-Dummy; the subject receives both experimental drug and placebo. 1 x 8 mg capsule each morning approximately 45 minutes (±15 minutes) prior to breakfast and 1 x 8 mg capsule each night prior to bedtime (between 8 PM to 12 Midnight and no sooner than 1 hour after dinner) and 1 placebo capsule at night.
Group Type
ACTIVE_COMPARATOR
ORMD-0801 8 mg
Intervention Type
DRUG
1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 2 placebo capsules (1 in the morning and 1 at night).
Placebo capsule
Intervention Type
OTHER
Placebo capsule
ORMD-0801 16 mg once-daily at night - QD
Double-Dummy; the subject receives both experimental drug and placebo. 2 x 8 mg capsules between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 1 placebo capsule in the morning.
Group Type
ACTIVE_COMPARATOR
Placebo capsule
Intervention Type
OTHER
Placebo capsule
ORMD-0801 16 mg
Intervention Type
DRUG
2 x 8 mg capsules between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 1 placebo capsule in the morning.
Placebo
The subject receives 3 placebo capsules.
Group Type
PLACEBO_COMPARATOR
Placebo capsule
Intervention Type
OTHER
Placebo capsule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ORMD-0801 8 mg
1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 2 placebo capsules (1 in the morning and 1 at night).
Intervention Type
DRUG
Placebo capsule
Placebo capsule
Intervention Type
OTHER
ORMD-0801 16 mg
2 x 8 mg capsules between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 1 placebo capsule in the morning.
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Oral Insulin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male and female subjects aged ≥ 50 years.
* Established diagnosis of T2DM for at least 6 months prior to Screening AND an A1C ≥ 7.2% but ≤ 10.0% at Screening.
* On a stable dose of at least one and up to three of the following glucose-lowering agents: Metformin, sulfonylurea, DPP-4 inhibitor, SGLT-2 inhibitor, thiazolidinedione, insulin secretagogue, oral or injected GLP-1 receptor agonists, glucosidase inhibitor, or pramlintide (injected insulin is excluded) for a minimum of 3 months prior to Screening.
* Body mass index (BMI) of ≤ 28 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:
* \- 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.
* Established diagnosis of T2DM for at least 6 months prior to Screening AND an A1C ≥ 7.2% but ≤ 10.0% at Screening.
* On a stable dose of at least one and up to three of the following glucose-lowering agents: Metformin, sulfonylurea, DPP-4 inhibitor, SGLT-2 inhibitor, thiazolidinedione, insulin secretagogue, oral or injected GLP-1 receptor agonists, glucosidase inhibitor, or pramlintide (injected insulin is excluded) for a minimum of 3 months prior to Screening.
* Body mass index (BMI) of ≤ 28 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:
* \- 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.
Exclusion Criteria
* Type 1 diabetes by history.
* 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 injected insulin within 3 months prior to Visit 1.
* A history of \> 2 episodes of severe hypoglycemia within 6 months prior to Screening.
* 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:
* \- - a. 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.
* \- - b. Elevated liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)) \> 3X the upper limit of normal; a single repeat test is allowable.
* \- - c. Very elevated fasting triglyceride levels (\> 600 mg/dL); a single repeat test is allowable.
* \- - d. 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:
* \- - -a. History of use of any injectable 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. Use of oral, intravenous, or intramuscular steroids for one month prior to enrollment. Intra-articular and/or topical corticosteroids are not considered systemic.
* \- - - d. Concurrent 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.
* Weight loss preparations either approved and marketed or used in OTC preparations except for GLP-1 used in the treatment of underlying diabetes.
* Any condition or other factor (at the Investigator's discretion) that is deemed unsuitable for subject enrollment into the study.
* 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 injected insulin within 3 months prior to Visit 1.
* A history of \> 2 episodes of severe hypoglycemia within 6 months prior to Screening.
* 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:
* \- - a. 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.
* \- - b. Elevated liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)) \> 3X the upper limit of normal; a single repeat test is allowable.
* \- - c. Very elevated fasting triglyceride levels (\> 600 mg/dL); a single repeat test is allowable.
* \- - d. 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:
* \- - -a. History of use of any injectable 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. Use of oral, intravenous, or intramuscular steroids for one month prior to enrollment. Intra-articular and/or topical corticosteroids are not considered systemic.
* \- - - d. Concurrent 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.
* Weight loss preparations either approved and marketed or used in OTC preparations except for GLP-1 used in the treatment of underlying diabetes.
* Any condition or other factor (at the Investigator's discretion) that is deemed unsuitable for subject enrollment into the study.
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
InClin, Inc.
UNKNOWN
Sponsor Role
collaborator
Oramed, Ltd.
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Miriam Kidron, Ph.D.
Role: STUDY_DIRECTOR
Oramed, Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Velocity Clinical Research Dallas
Dallas, Texas, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B; American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009 Jan;32(1):193-203. doi: 10.2337/dc08-9025. Epub 2008 Oct 22.
Reference Type
BACKGROUND
Nathan DM, Buse JB, Davidson MB, Heine RJ, Holman RR, Sherwin R, Zinman B. Management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2006 Aug;29(8):1963-72. doi: 10.2337/dc06-9912. No abstract available.
Reference Type
BACKGROUND
Li X, Yang S, Cao C, Yan X, Zheng L, Zheng L, Da J, Tang X, Ji L, Yang X, Zhou Z. Validation of the Swedish Diabetes Re-Grouping Scheme in Adult-Onset Diabetes in China. J Clin Endocrinol Metab. 2020 Oct 1;105(10):dgaa524. doi: 10.1210/clinem/dgaa524.
Reference Type
BACKGROUND
ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 3. Prevention or Delay of Type 2 Diabetes and Associated Comorbidities: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S41-S48. doi: 10.2337/dc23-S003.
Reference Type
BACKGROUND
Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
Reference Type
BACKGROUND
Cleary PA, Orchard TJ, Genuth S, Wong ND, Detrano R, Backlund JY, Zinman B, Jacobson A, Sun W, Lachin JM, Nathan DM; DCCT/EDIC Research Group. The effect of intensive glycemic treatment on coronary artery calcification in type 1 diabetic participants of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study. Diabetes. 2006 Dec;55(12):3556-65. doi: 10.2337/db06-0653.
Reference Type
BACKGROUND
Mansour Aly D, Dwivedi OP, Prasad RB, Karajamaki A, Hjort R, Thangam M, Akerlund M, Mahajan A, Udler MS, Florez JC, McCarthy MI; Regeneron Genetics Center; Brosnan J, Melander O, Carlsson S, Hansson O, Tuomi T, Groop L, Ahlqvist E. Genome-wide association analyses highlight etiological differences underlying newly defined subtypes of diabetes. Nat Genet. 2021 Nov;53(11):1534-1542. doi: 10.1038/s41588-021-00948-2. Epub 2021 Nov 4.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ORA-D-013-3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus
NCT02954601
COMPLETED
PHASE2
A Study to Assess the Safety and Efficacy of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011)
NCT01717313
COMPLETED
PHASE3
A Clinical Study to Assess the Safety, Tolerability, and Activity of Oral SRT2104 Capsules Administered for 28 Days to Subjects With Type 2 Diabetes Mellitus
NCT01018017
COMPLETED
PHASE2
A Dose-Range Finding Study in Participants With Type 2 Diabetes (MK-3102-006)
NCT01217073
COMPLETED
PHASE2
Study of Multiple Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
NCT05158244
COMPLETED
PHASE1
A Study to Evaluate Safety and Efficacy of TTP273 for 12 Weeks in Subjects With Type 2 Diabetes
NCT02653599
COMPLETED
PHASE2
A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)
NCT04618744
COMPLETED
PHASE2
Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)
NCT01697592
COMPLETED
PHASE3
Safety and Efficacy of Once-Daily KRP-104 in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Alone
NCT00995345
COMPLETED
PHASE2
A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes Mellitus
NCT00963768
COMPLETED
PHASE1
Omarigliptin Add-on to Insulin in Japanese Participants With Type 2 Diabetes Mellitus (T2DM, MK-3102-039)
NCT02906709
COMPLETED
PHASE4
Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)
NCT02935712
COMPLETED
PHASE1
A Safety and Efficacy Study of T0903131 (INT131) Besylate to Treat Type 2 Diabetes Mellitus
NCT00952445
COMPLETED
PHASE2
A Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Doses Of PF-04937319 In Subjects With Type 2 Diabetes Mellitus
NCT01044537
COMPLETED
PHASE1
A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2737 in Healthy Subjects
NCT03410979
COMPLETED
PHASE1
Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.
NCT06579105
COMPLETED
PHASE2
Safety Study of BMS-903452 in Healthy Subjects (Panel 1-7) & Relative Bioavailability of the Crystalline and Amorphous Forms of BMS-903452 [Panels 4, 6, 11 & 12(Part A)], and Subjects With Type 2 Diabetes Mellitus (Part B)
NCT01240980
COMPLETED
PHASE1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 14332 CL as Tablet in Female and Male Patients With Type 2 Diabetes
NCT02212925
TERMINATED
PHASE1
Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)
NCT01703221
COMPLETED
PHASE3
A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug On Adults With Type 2 Diabetes Mellitus Taking Metformin
NCT02053103
TERMINATED
PHASE2
Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
NCT00817778
COMPLETED
PHASE2
A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2)
NCT00846391
TERMINATED
PHASE2
Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
NCT04305587
COMPLETED
PHASE1