Diabetes Type 2Phase 2NCT02496000
Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing ORMD-0801 in people with Diabetes Type 2, run by Oramed, Ltd. at 34 sites in United States.
Trial summary
Randomized, double-blind, placebo-controlled, parallel group study. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- ORMD-0801
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 34 sitesUnited States
- Study dates
- 27 Jul 2015to 13 Sep 2016
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c ≥7.5% if naïve to antidiabetic therapy; ≥6.5% and ≤10% if on metformin ≥1,500 mg daily; ≥6.5% and ≤9.5% if on monotherapy with an antidiabetic drug other than metformin; ≥ 6.5% and ≤9.5% if on metformin and one other antidiabetic drug; ≥ 7.0% if on metformin <1,500 mg daily.
- At time of randomization, patients will be treated for their diabetes by diet, exercise, and metformin (≥1500 mg/day; any type and regimen). Patients will have been on a stable regimen of metformin (defined as the same metformin dose and type) for at least two weeks prior to entering the single-blind placebo run-in period.
- Other antidiabetic agents will not be used for the two weeks prior to entering the placebo run-in period.
- Patients in whom the maximum tolerated dose (MTD) of metformin is 1,000 mg will be allowed to enter the study.
- At Day -7 (Visit 3), all patients will have HbA1c ≥ 6.5% and ≤10%.
- Body Mass Index between 25 and 40 kg/m2, inclusive.
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- Fasting blood glucose ≥ 126 mg/dL (8.3 mmol/L) prior to randomization at Day -7 (Visit 3). For patients in whom the Day -7 (Visit 3) fasting blood glucose is <126 mg/dL and ≥ 115 mg/dL, and the Day -7 (Visit 3) HbA1C is ≥ 7% and ≤ 10%, a minimum of 5 daily self- monitored fasting blood glucose checks recorded in the patient diary can be averaged. If the average value is ≥ 126 mg/dL, the patient may continue in the trial.
- Females of childbearing potential must have a negative urine pregnancy test result at screening. A negative urine pregnancy test must be obtained during Visit 2 and at Visit 4 (prior to randomization).
- Males and females of childbearing potential must use two methods of contraception (double barrier method), one of which must be an acceptable barrier method from the time of screening to the last study visit (Day 43).
- Patient has >80% compliance with placebo during run in prior to randomization.
- Patient has ≥ 80% of the glucose readings on at least two 24 hour periods (6AM - 6AM) during the seven day CGM period.
- Patient has performed ≥ 10/14 of the self monitored glucose level measurements during placebo run-in, prior to randomization.
Who cannot join
- Patients who meet any of the following criteria are not eligible for this study.
- Presence of any clinically significant endocrine disease according to the Investigator (euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least six weeks prior to Screening Visit).
- Clinical diagnosis of Type 1 diabetes.
- Fasting blood glucose >260 mg/dL at the end of Day -7/Visit 3. For patient in whom the Day 07 (Visit 3) fasting blood glucose is > 260 mg/dL and < 300 mg/dL, and the Day -7 (Visit 3) HbA1C is ≥ 7% and ≤ 10%, a minimum of 5 self-monitored fasting blood glucose checks recorded in the patient diary can be averaged. If the average value is ≤ 260 mg/dL, the patient may continue in the trial.
- Presence or history of cancer within the past five years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer.
- Laboratory abnormalities at screening including:
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- C-peptide < 1.0 ng/mL.
- Positive pregnancy test in females of childbearing potential (at screening and start of run-in period).
- Abnormal serum thyrotropin (TSH) levels >1.5 times the upper limit of normal.
- Positive test for hepatitis B surface antigen and/or hepatitis C antibody.
- Positive test for HIV.
- Serum Cr >1.4mg/dl in males, >1.3mg/dl in females.
- Any relevant abnormality interfering with the efficacy or the safety assessments during study drug administration.
- Use of the following medications:
- History of use of insulin for greater than one week in the last six months and any use of insulin in the last six weeks prior to randomization.
- Administration of anti-diabetic drugs other than metformin within four weeks prior to randomization visit. Administration of thyroid preparations or thyroxine within six weeks prior to screening visit. (Patients on stable thyroid replacement therapy for greater than 6 weeks may enter the study.)
- Administration of systemic long-acting corticosteroids within two months or prolonged use (more than one week) of other systemic corticosteroids or inhaled corticosteroids within 30 days prior to screening visit.
- 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), beta blockers (with the exception of beta blocker ophthalmic solutions for glaucoma or ocular hypertension), and immunosuppressive or immunomodulating agents.
- History of tobacco or nicotine use in excess of two packs/day within ten weeks prior to screening.
- Patient is on a weight loss program and is not in the maintenance phase, or patient that started any approved or non approved weight loss medication within eight weeks prior to screening.
- Pregnancy or breast-feeding.
- Patient has a screening visit systolic blood pressure of ≥160 mm Hg or diastolic blood pressure of ≥100 mm Hg Patients will be allowed to take BP medication as long as they have been on a stable dose for a period of four weeks prior to the screening visit.
- Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) 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).
- Elevated liver enzymes (alanine transaminase (ALT), alanine aminotransferase (AST), alkaline phosphatase) greater than two times the upper limit of normal at screening.
- Very high triglyceride level (>500 mg/dL) at screening.
- Any clinically significant electrocardiogram (ECG) abnormality at screening or cardiovascular disease. Clinically significant cardiovascular disease will include:
- History of stroke, transient ischemic attack, or myocardial infarction within six months prior to screening,
- History of or currently have New York Heart Associate Class II-IV heart failure prior to screening, or
- Uncontrolled hypertension defined as blood pressure ≥160 mmHg (systolic) or ≥100 mmHg (diastolic) at screening.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Dream Team Clinical Research
Anaheim, California, 92801
Maine Research Associates
Auburn, Maine, 04210
Meridien Research
Bradenton, Florida, 34208
Meridien Research
Brooksville, Florida, 34601
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Padre Coast Clinical Research
Corpus Christi, Texas, 78404
Creekside Endocrine Associates, PC
Denver, Colorado, 80209
Apex Medical Research, MI, Inc
Flint, Michigan, 48504
Upstate Pharmaceutical Research
Greenville, South Carolina, 29615
Research in Miami Inc.
Hialeah, Florida, 33013
Research in Miami, Inc.
Hialeah, Florida, 33013
Impact Clinical Trials
Las Vegas, Nevada, 89106
Arkansas Primary Care Clinic, PA
Little Rock, Arkansas, 72204
ACTCA, Inc.
Los Angeles, California, 90017
ACTCA
Los Angeles, California, 90036
National Research Institute
Los Angeles, California, 90057
Phoenix Medical Research LLC
Miami, Florida, 33165
New York Clinical Trials
New York, New York, 10018
Lynn Institute of Norman
Norman, Oklahoma, 73069
Providence Clinical Research
North Hollywood, California, 91606
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174
Steingard Medical Group
Phoenix, Arizona, 85015
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107
Sun Research Institute
San Antonio, Texas, 78215
Southwest Clinic
San Antonio, Texas, 78221
Panacea Clinical Research
San Antonio, Texas, 78228
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Mills-Peninsula Health Services
San Mateo, California, 94401
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603
Meridien Research
Tampa, Florida, 33634
Orange County Research Center
Tustin, California, 92780
Metabolic Research Institute, Inc
West Palm Beach, Florida, 33401
Heartland Research Associates, LLC
Wichita, Kansas, 67207
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Diet and Metformin
Randomized, double-blind, placebo-controlled, parallel group study.
Read the detailed description
This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, parallel group study. After appropriate screening, approximately 180 male and female patients from up to 33 study centers will be treated in this study. Patients with type 2 diabetes mellitus who are being treated by diet, exercise, untreated with antidiabetic medications or treated with and metformin monotherapy or in combination with one other antidiabetic drug (excluding insulin) are eligible for enrollment.
- Conditions
- Diabetes Type 2
- Being tested
- ORMD-0801, Placebo Comparator
- Keywords
- Diabetes Mellitus type 2, Metformin, oral insulin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORMD-0801Drug
Also called Oral Insulin
Oral Insulin
Placebo ComparatorDrug
Also called Placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | three identical capsules containing placebo Receives: Drug: Placebo Comparator |
| ORMD-0801 Dose 1 | Experimental | three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo Receives: Drug: ORMD-0801 |
| ORMD-0801 Dose 2 = 1.5 * Dose 1 | Experimental | three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1 Receives: Drug: ORMD-0801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the Mean Night Time Glucose Levels Based on Two Nights of Glucose Measurements.
The Effect of ORMD-0801 (Doses 1 \& 2, Pooled) on Mean Night Time Glucose Levels (measured in mg/dL) Based on 2 Nights of Continuous Glucose Monitor (CGM) Data by Comparison of the Mean Change Between Baseline and Wk 4 of ORMD-0801 Treatment and Placebo Groups. The primary analysis will be based on the results from the two last days, unless technical difficulties preclude calculation of the weighted mean glucose levels. In this case, the last two days (selected between days 5, 6, and 7) with at least 80% of the expected number of measurements will be used. If days 5, 6 and 7 do not have 2 days with at least 80% of the expected number of measurements for a specific subject, then the value will be missing for that subject.
Measured: Baseline-Study day -7 (± 1 day) through Study day 1 (± 1 day), and Week 4 -Study day 22 (± 1 day) through Study day 29 (± 1 day)
Secondary outcomes (4)
The Effect of ORMD-0801 on Mean 24-hour Glucose
The effect of ORMD-0801 (Dose 1 and Dose 2 individually) on mean 24-hour glucose based on 2 nights of CGM data by comparison of the mean percent change between baseline and Wk 4 of ORMD-0801 treatment and the placebo groups.
Measured: Study day -7 (± 1 day) through Study day 1 (± 1 day), and Study day 22 (±1 day) - Study day 29 (± 1 day)
Measure Percent Change in Continuous Glucose Monitoring Mean Fasting Glucose Between Treatment and Run-In
The percent change in the Continuous Glucose Monitoring Mean Fasting Glucose between treatment and mean of the last two days of the baseline(run-in period).
Measured: Baseline (Run-in days 13-14) and Study day 1 (± 1 day) through Study day 29 (± 1 day)
Measure the Change From Baseline to End of the Study of Morning Fasting C-Peptide (Nmol/L)
The measurement of the change in Morning Fasting C-peptide between baseline to end of the study, measured in Nmol/L
Measured: Study day 1 (±1 day) through Study day43 (± 1 day)
The Effect of ORMD-0801 on the Percent Change in HbA1c
The effect of ORMD-0801 (Dose 1 and Dose 2 individually) on the percent change from baseline to Wk 4 in HbA1c
Measured: Study day 1 (± 1 day) through Study day 29 (± 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study start27 Jul 2015
- Primary completion27 Jun 2016
- Study completion13 Sep 2016
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 Diabetes 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 188 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
- NCT02496000
- Sponsor's protocol ID
- ORA-D-007
- Status last verified
- Oct 2019
- First submitted
- 8 Jul 2015
- Last updated
- 13 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Diet and Metformin
- ClinicalTrials.gov ID
- NCT02496000
- Acronym / sponsor ID
- ORA-D-007
- Conditions
- Diabetes Type 2
- Keywords
- Diabetes Mellitus type 2, Metformin, oral insulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Oramed, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Study start
- 27 Jul 2015 (actual)
- Primary completion
- 27 Jun 2016 (actual)
- Study completion
- 13 Sep 2016 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Posted 17 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind, placebo-controlled, parallel group study.
Detailed description
This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, parallel group study. After appropriate screening, approximately 180 male and female patients from up to 33 study centers will be treated in this study. Patients with type 2 diabetes mellitus who are being treated by diet, exercise, untreated with antidiabetic medications or treated with and metformin monotherapy or in combination with one other antidiabetic drug (excluding insulin) are eligible for enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Drug: Placebo Comparatorthree identical capsules containing placebo |
| ORMD-0801 Dose 1 | Experimental | Drug: ORMD-0801three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo |
| ORMD-0801 Dose 2 = 1.5 * Dose 1 | Experimental | Drug: ORMD-0801three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- HbA1c ≥7.5% if naïve to antidiabetic therapy; ≥6.5% and ≤10% if on metformin ≥1,500 mg daily; ≥6.5% and ≤9.5% if on monotherapy with an antidiabetic drug other than metformin; ≥ 6.5% and ≤9.5% if on metformin and one other antidiabetic drug; ≥ 7.0% if on metformin <1,500 mg daily.
- At time of randomization, patients will be treated for their diabetes by diet, exercise, and metformin (≥1500 mg/day; any type and regimen). Patients will have been on a stable regimen of metformin (defined as the same metformin dose and type) for at least two weeks prior to entering the single-blind placebo run-in period.
- Other antidiabetic agents will not be used for the two weeks prior to entering the placebo run-in period.
- Patients in whom the maximum tolerated dose (MTD) of metformin is 1,000 mg will be allowed to enter the study.
- At Day -7 (Visit 3), all patients will have HbA1c ≥ 6.5% and ≤10%.
Key exclusion criteria (29 listed)
- Patients who meet any of the following criteria are not eligible for this study.
- Presence of any clinically significant endocrine disease according to the Investigator (euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least six weeks prior to Screening Visit).
- Clinical diagnosis of Type 1 diabetes.
- Fasting blood glucose >260 mg/dL at the end of Day -7/Visit 3. For patient in whom the Day 07 (Visit 3) fasting blood glucose is > 260 mg/dL and < 300 mg/dL, and the Day -7 (Visit 3) HbA1C is ≥ 7% and ≤ 10%, a minimum of 5 self-monitored fasting blood glucose checks recorded in the patient diary can be averaged. If the average value is ≤ 260 mg/dL, the patient may continue in the trial.
- Presence or history of cancer within the past five years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORMD-0801Also: Oral InsulinOral Insulin | Drug | ORMD-0801 Dose 1, ORMD-0801 Dose 2 = 1.5 * Dose 1 |
| Placebo ComparatorAlso: PlaceboPlacebo | Drug | Placebo Comparator |
Primary outcome
Measure of the Mean Night Time Glucose Levels Based on Two Nights of Glucose Measurements.
Time frame: Baseline-Study day -7 (± 1 day) through Study day 1 (± 1 day), and Week 4 -Study day 22 (± 1 day) through Study day 29 (± 1 day)
The Effect of ORMD-0801 (Doses 1 \& 2, Pooled) on Mean Night Time Glucose Levels (measured in mg/dL) Based on 2 Nights of Continuous Glucose Monitor (CGM) Data by Comparison of the Mean Change Between Baseline and Wk 4 of ORMD-0801 Treatment and Placebo Groups. The primary analysis will be based on the results from the two last days, unless technical difficulties preclude calculation of the weighted mean glucose levels. In this case, the last two days (selected between days 5, 6, and 7) with at least 80% of the expected number of measurements will be used. If days 5, 6 and 7 do not have 2 days with at least 80% of the expected number of measurements for a specific subject, then the value will be missing for that subject.
4 secondary outcomes
The Effect of ORMD-0801 on Mean 24-hour Glucose
Time frame: Study day -7 (± 1 day) through Study day 1 (± 1 day), and Study day 22 (±1 day) - Study day 29 (± 1 day)
Measure Percent Change in Continuous Glucose Monitoring Mean Fasting Glucose Between Treatment and Run-In
Time frame: Baseline (Run-in days 13-14) and Study day 1 (± 1 day) through Study day 29 (± 1 day)
Measure the Change From Baseline to End of the Study of Morning Fasting C-Peptide (Nmol/L)
Time frame: Study day 1 (±1 day) through Study day43 (± 1 day)
The Effect of ORMD-0801 on the Percent Change in HbA1c
Time frame: Study day 1 (± 1 day) through Study day 29 (± 1 day)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel M Neutel, M.D. principal investigator
Orange County Research Center
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ORMD-0801 in people with Diabetes Type 2, run by Oramed, Ltd. at 34 sites 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 12 inclusion and 29 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 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites 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 17 Feb 2017). 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?
Measure of the Mean Night Time Glucose Levels Based on Two Nights of Glucose Measurements. (time frame: Baseline-Study day -7 (± 1 day) through Study day 1 (± 1 day), and Week 4 -Study day 22 (± 1 day) through Study day 29 (± 1 day)). 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 13 Nov 2019.