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CompletedNCT04564846Updated May 7, 2024Results posted

A Study to Evaluate the Effect of ORMD-0801 in Patients With Type 2 Diabetes Mellitus

A Phase 2 interventional study of ORMD-0801 and Placebo in Diabetes Mellitus, Type 2, sponsored by Oramed, Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-07.

Sponsored by Oramed, Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 3,300 studies in Diabetes Mellitus, Type 2 with a site in United States — 340 open to participants now, 475 under way, 47 of them phase 3. Diabetes Mellitus, Type 2 · United States.

Enrollment
1,906th of 2,953
49 · median 90
Started
2020
with 96 others
Phase 2
391 of 3,300
24 open now
Registered
2,399th of 3,300
by date

Among the 3,300 studies in Diabetes Mellitus, Type 2 with a site in United States, this one is the 1,906th largest by enrollment of the 2,953 interventional ones, is one of 97 that started in 2020, is one of 391 in phase 2, and was the 2,399th registered.

By phase

3,300 studies; the count open now beside each. This study's row is marked.

No phase1,240 · 201 open
Phase 3576 · 30 open
Phase 2this study391 · 24 open
Phase 1383 · 24 open
Observational336 · 38 open
Phase 4300 · 19 open
Phase 1/240 · 3 open
Phase 2/333 · 1 open
Other kind1 · 0 open

By the year they started

First in 1976; this study’s year is marked. 97 started in 2020.

Size and results

Median enrollment 90 across the 2,953 interventional studies, 128 across the 336 observational. Of the 2,648 that completed or were terminated, 1,165 (44%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 3,300 studies in Diabetes Mellitus, Type 2 with a site in United States, or all of them as a file.
02

Study summary

This study is designed to explore the efficacy of ORMD-0801 compared to placebo on endogenous glucose production in subjects with type 2 diabetes (T2DM). Subjects will undergo an initial Screening Visit (Visit 0) to establish their eligibility to participate in the study. At Visit 1 (2 weeks after the Screening Visit), qualifying subjects will be randomized to either ORMD-0801 (8 mg) or matching placebo, study medication will be dispensed and subjects will dose, twice a day, once in the morning prior to breakfast and once at night prior to bedtime

Read the detailed description

This study is designed to explore the efficacy of ORMD-0801 compared to placebo on endogenous glucose production in subjects with type 2 diabetes (T2DM). Subjects will undergo an initial Screening Visit (Visit 0) to establish their eligibility to participate in the study. At Visit 1 (2 weeks after the Screening Visit), qualifying subjects will be randomized to either ORMD-0801 (8 mg) or matching placebo, study medication will be dispensed and subjects will dose, twice a day, once in the morning prior to breakfast and once at night prior to bedtime. Doses will occur at 45 minutes (± 15 minutes) before breakfast and no later than 10 AM each morning, and at 8 PM (± 120 minutes) each night, and no sooner than 1 hour after dinner. Subjects will return to the clinic, 2 weeks later, for Visit 2. At this visit, subject compliance will be assessed, medication will be dispensed, a blood sample will be collected to measure HbA1c and subjects will be questioned for any adverse events. Subjects will be scheduled to return to the clinic in 2 weeks for morning admission (8 AM ± 120 minutes) to the PK unit (Visit 3). Subjects will be provided with standardized meals and the morning dose in-clinic. A light standardized dinner meal will be provided at 6 PM ± 30 minutes. At approximately 8 PM (± 60 minutes, and no sooner than 1 hour after dinner), subjects will be dosed with their study medication and will be started on a 16-hour infusion of [6,6-2H2]-glucose tracer.

03

Conditions studied

  • Diabetes Mellitus, Type 2
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female subjects aged, 18 - 70 years.
  • Established diagnosis of T2DM for at least 6 months prior to Screening, with ≥ 7.5%. and ≤ 11%.
  • Stable dose of metformin (at least 1500 mg or maximal tolerated dose) 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, SGLT-2, or TZD.
  • (BMI) of up to 35 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 - > 30 ml/min/1.73 m2.
  • Females of must have a negative serum pregnancy test result at Screening.

Exclusion criteria

Exclusion Criteria:

  • Subjects with insulin-dependent diabetes:

    1. 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).
    2. 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.
  • 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:

    1. 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.
    2. Renal dysfunction: estimated \< 30 ml/min.
    3. History of proliferative retinopathy or severe form of neuropathy or cardiac autonomic neuropathy (CAN).
    4. 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.
    5. Presence of unstable angina or myocardial infarction within 6 months prior to Screening, Grade 3 or 4 congestive heart failure (CHF) according to the (NYHA) criteria, valvular heart disease, cardiac arrhythmia requiring treatment, pulmonary hypertension, cardiac surgery, history/occurrence of coronary angioplasty and/or stroke or (TIA) within 6 months prior to Screening.
  • Subjects with psychiatric disorders which, per investigator judgment, may have impact on the safety of the subject or interfere with subject's participation or compliance in the study.
  • Subjects who needed (in the last 12 months) or may require systemic (oral, intravenous, intramuscular) therapy for more than 2 weeks during the study period.

  • Laboratory abnormalities at Screening including:

    1. C-peptide \< 0.7 ng/mL (0.23 nmol/L).
    2. Abnormal serum thyrotropin (TSH) levels below the lower limit of normal or > 1.5X the .
    3. Elevated liver enzymes ( (ALT), alanine aminotransferase (AST), alkaline phosphatase) > 2X the upper limit of normal.
    4. Very high triglyceride levels (> 600 mg/dL); a single repeat test is allowable.
    5. 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), including chronic or C, primary biliary cirrhosis, or active symptomatic gallbladder disease.
  • Positive history of .

  • Use of the following medications:

    1. History of any basal, pre-mix or prandial insulin (greater than 7 days) within 6 months prior to Screening.
    2. Administration of thyroid preparations or thyroxine (except in subjects on stable replacement therapy) within 6 weeks prior to Screening.
    3. 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.
    4. 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 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 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.
  • Subject is smoking more than 10 cigarettes per day.
  • One or more 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 factor that is deemed unsuitable for subject enrollment into the study.
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
49 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Subjects will be administered a single capsule of placebo( fish oil); placebo will be dispensed and subjects will dose twice a day, once in the morning prior to breakfast and once at night prior to bedtime.

    Other: Placebo

  • Active comparator
    ORMD-0801

    Subjects will be administered a single 8mg capsule of ORMD-0801; study medication will be dispensed and subjects will dose twice a day, once in the morning prior to breakfast and once at night prior to bedtime.

    Drug: ORMD-0801

Interventions

  • DrugORMD-0801

    8 mg capsules of ORMD-0801 (Oral Insulin)

    Also known as: Oral Insulin

  • OtherPlacebo

    Placebo capsule (Fish Oil)

    Also known as: Fish Oil

06

What researchers measure

Primary outcomes

  1. Area Under the Curve (AUC(0-16)) of Endogenous Glucose Production

    The endogenous glucose production in ORMD-0801 and placebo measured by the glucose with tracer attached using AUC(0-16) as the primary parameter. The intravenous infusion of \[6,6-2H2\]-glucose tracer is administered following administraiton of either placebo or intervention. The pharmacokinetic time points are basline (pre dose), 0.75 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 5 hr, 6 hr, 7 hr, 8 hr, 9 hr, 10 hr, 11 hr, 12 hr, 13 hr, 14 hr, 15 hr, 16 hr post-dose.

    Time frame: Day 28 (1 day)

Secondary outcomes

  1. Mean Changes in HbA1c

    Mean Changes of HbA1c measured in percentage of glycated hemoglobin

    Time frame: baseline to Day 29 of the treatment period.

  2. Area Under the Curve AUC(0-16) of Metabolite Beta-hydroxybutyrate

    AUC(0-16) measured in umol\*hr/L with blood draws at baseline ( time "0", prior to drug administration), then 45 min, 90 min, 120 min, 150 min, 3-16 hours in one-hour intervals post intervention plus tracer administration via intravenous infusion of \[6,6-2H2\]-glucose tracer. The AUC measured is AUC(0-16) where "0-16" is 0 pre-dose, 0.75 hr. 1.5 hrs, 2 hrs. 2.5 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 7 hrs, 8 hrs, 9 hrs, 10 hrs, 11 hrs, 12 hrs, 13 hrs, 14 hrs, 15 hrs, 16 hrs. post dose.

    Time frame: Day 28

  3. Area Under the Curve (AUC) of Insulin

    The Area Under the Cuve (AUC) measured from baseline (prior to placebo, intervention, and tracer infusion) to sixteen hours post treatment andministration and tracer infusion administration. The tracer is \[6,6-2H2\]-glucose tracer using AUC(0-16). Pharmacokinetic time points are: Baseline (0 hr, pre-dose), then 0.75 hr, 1.5 hrs, 2 hrs, 2.5 hrs., 3 hrs., 4 hrs, 5 hrs, 6 hrs, 7hrs, 8 hrs, 9 hrs, 10 hrs, 11 hrs 12 hrs, 13 hrs, 14 hrs, 15 hrs, 16 hrs (post dose).

    Time frame: Day 28 (one day)

  4. Area Under the Curve (AUC) of Free Fatty Acids (FFA)

    AUC measured from Baseline (prior to administration of placebo orintervention and to tracer infusion. The tracer is \[6,6-2H2\]-glucose tracer using AUC(0-16). Pharmacokinetic time points are: Baseline (0 hr, pre-dose), then 0.75 hr, 1.5 hrs, 2 hrs, 2.5 hrs., 3 hrs., 4 hrs, 5 hrs, 6 hrs, 7hrs, 8 hrs, 9 hrs, 10 hrs, 11 hrs 12 hrs, 13 hrs, 14 hrs, 15 hrs, 16 hrs (post dose).

    Time frame: Day 28 (one day)

  5. Mean Changes Plasma Glucose Levels

    Mean changes in plasma glucose levels measured in mg/dL. In this outcome measure, the change from baseline of mean plasma glucose for the placebo arm is calculated as: Mean Plasma Glucose (Day 29, 21 subjects) - Mean Plasma Glucose (Baseline, 21 subjects). The Baseline Mean Plasma Glucose based on 21 subjects is 192.7 mg/dL. Therefore, 192.7 mg/dL - 212.3 mg/dL = -19.6 mg./dL

    Time frame: baseline to Day 29 of the treatment period.

07

Results

Posted May 7, 2024

Participant flow

Participant flow — Overall Study
MilestonePlaceboORMD-0801
Started2524
Completed2120
Not completed44
Withdrew: Withdrawal by subject21
Withdrew: Physician decision01
Withdrew: Lost to follow-up01
Withdrew: Principal investigator requested that the patient withdraw from the study11
Withdrew: Subject non-compliance10

Outcome measures

PrimaryArea Under the Curve (AUC(0-16)) of Endogenous Glucose Production

The endogenous glucose production in ORMD-0801 and placebo measured by the glucose with tracer attached using AUC(0-16) as the primary parameter. The intravenous infusion of \[6,6-2H2\]-glucose tracer is administered following administraiton of either placebo or intervention. The pharmacokinetic time points are basline (pre dose), 0.75 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 5 hr, 6 hr, 7 hr, 8 hr, 9 hr, 10 hr, 11 hr, 12 hr, 13 hr, 14 hr, 15 hr, 16 hr post-dose.

Time frame:
Day 28 (1 day)
Reported as:
Mean · mg*hr/dL
Area Under the Curve (AUC(0-16)) of Endogenous Glucose Production
mg*hr/dLPlaceboORMD-0801
Area Under the Curve (AUC(0-16)) of Endogenous Glucose Production3436.8 ± 922.893139.3 ± 830.29
Statistical analysis
  • Placebo vs ORMD-0801 · Analysis of Covariance · p = 0.1628 · Risk ratio (rr): 0.974 · 95% CI 0.938 to 1.011Estimated Difference from Placebo Across All Time Points. Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.
SecondaryMean Changes in HbA1c

Mean Changes of HbA1c measured in percentage of glycated hemoglobin

Time frame:
baseline to Day 29 of the treatment period.
Reported as:
Mean · percentage of glycated hemoglobin
Mean Changes in HbA1c
percentage of glycated hemoglobinPlaceboORMD-0801
Baseline HbA1c9.20 ± 1.2148.51 ± 1.401
Day 29 HbA1c9.19 ± 1.1968.67 ± 1.319
Difference of HbA1c between baseline and Day 290.08 ± 0.4520.15 ± 0.637
SecondaryArea Under the Curve AUC(0-16) of Metabolite Beta-hydroxybutyrate

AUC(0-16) measured in umol\*hr/L with blood draws at baseline ( time "0", prior to drug administration), then 45 min, 90 min, 120 min, 150 min, 3-16 hours in one-hour intervals post intervention plus tracer administration via intravenous infusion of \[6,6-2H2\]-glucose tracer. The AUC measured is AUC(0-16) where "0-16" is 0 pre-dose, 0.75 hr. 1.5 hrs, 2 hrs. 2.5 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 7 hrs, 8 hrs, 9 hrs, 10 hrs, 11 hrs, 12 hrs, 13 hrs, 14 hrs, 15 hrs, 16 hrs. post dose.

Time frame:
Day 28
Reported as:
Mean · umol*hr/L
Area Under the Curve AUC(0-16) of Metabolite Beta-hydroxybutyrate
umol*hr/LPlaceboORMD-0801
Area Under the Curve AUC(0-16) of Metabolite Beta-hydroxybutyrate3435.8 ± 3093.362009.7 ± 1659.04
Statistical analysis
  • Placebo vs ORMD-0801 · Analysis of Covariance · p = 0.0674 · Risk ratio (rr): 0.784 · 95% CI 0.605 to 1.017
SecondaryArea Under the Curve (AUC) of Insulin

The Area Under the Cuve (AUC) measured from baseline (prior to placebo, intervention, and tracer infusion) to sixteen hours post treatment andministration and tracer infusion administration. The tracer is \[6,6-2H2\]-glucose tracer using AUC(0-16). Pharmacokinetic time points are: Baseline (0 hr, pre-dose), then 0.75 hr, 1.5 hrs, 2 hrs, 2.5 hrs., 3 hrs., 4 hrs, 5 hrs, 6 hrs, 7hrs, 8 hrs, 9 hrs, 10 hrs, 11 hrs 12 hrs, 13 hrs, 14 hrs, 15 hrs, 16 hrs (post dose).

Time frame:
Day 28 (one day)
Reported as:
Mean · uU*hr/mL
Area Under the Curve (AUC) of Insulin
uU*hr/mLPlaceboORMD-0801
Area Under the Curve (AUC) of Insulin324.8 ± 147.25425.1 ± 274.61
Statistical analysis
  • Placebo vs ORMD-0801 · Analysis of Covariance · p = 0.8182 · Risk ratio, log: 1.067 · 95% CI 0.976 to 1.167
SecondaryArea Under the Curve (AUC) of Free Fatty Acids (FFA)

AUC measured from Baseline (prior to administration of placebo orintervention and to tracer infusion. The tracer is \[6,6-2H2\]-glucose tracer using AUC(0-16). Pharmacokinetic time points are: Baseline (0 hr, pre-dose), then 0.75 hr, 1.5 hrs, 2 hrs, 2.5 hrs., 3 hrs., 4 hrs, 5 hrs, 6 hrs, 7hrs, 8 hrs, 9 hrs, 10 hrs, 11 hrs 12 hrs, 13 hrs, 14 hrs, 15 hrs, 16 hrs (post dose).

Time frame:
Day 28 (one day)
Reported as:
Mean · uEq*hr/L
Area Under the Curve (AUC) of Free Fatty Acids (FFA)
uEq*hr/LPlaceboORMD-0801
Area Under the Curve (AUC) of Free Fatty Acids (FFA)7327.2 ± 1820.317051.4 ± 1788.71
Statistical analysis
  • Placebo vs ORMD-0801 · Analysis of Covariance · p = 0.8182 · Risk ratio, log: 1.007 · 95% CI 0.951 to 1.066
SecondaryMean Changes Plasma Glucose Levels

Mean changes in plasma glucose levels measured in mg/dL. In this outcome measure, the change from baseline of mean plasma glucose for the placebo arm is calculated as: Mean Plasma Glucose (Day 29, 21 subjects) - Mean Plasma Glucose (Baseline, 21 subjects). The Baseline Mean Plasma Glucose based on 21 subjects is 192.7 mg/dL. Therefore, 192.7 mg/dL - 212.3 mg/dL = -19.6 mg./dL

Time frame:
baseline to Day 29 of the treatment period.
Reported as:
Mean · mg/dL
Mean Changes Plasma Glucose Levels
mg/dLPlaceboORMD-0801
Plasma Glucose at Baseline216.4 ± 55.37187.5 ± 48.6
Plasma Glucose at Day 29192.7 ± 51.62167.9 ± 48.58
Change in Plasma Glucose from Baseline-19.6 ± 46.61-19.6 ± 39.68
Statistical analysis
  • Placebo vs ORMD-0801 · Analysis of variance: 0.4628

Adverse events

Collected over Baseline (day 0) until discharge/end-of-study day (day 29). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/25 (0%)0/25 (0%)3/25 (12%)
ORMD-08010/24 (0%)0/24 (0%)6/24 (25%)
Most frequent other events
Most frequent other events
EventPlaceboORMD-0801
Gastrointestinal disordersGastrointestinal disorders0/253/24
HeadacheNervous system disorders2/253/24
Abdominal painGastrointestinal disorders0/251/24
Gastrointestinal disordersGastrointestinal disorders0/251/24
CoughRespiratory, thoracic and mediastinal disorders0/251/24
HyperhidrosisSkin and subcutaneous tissue disorders0/251/24
AnxietyPsychiatric disorders1/250/24
DisorientationPsychiatric disorders1/250/24

Baseline characteristics

Age, Continuous
Age, Continuous(Years)PlaceboORMD-0801Total
Mean60.19 ± 6.49758.68 ± 6.90459.45 ± 6.742
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboORMD-0801Total
Female71017
Male181432
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboORMD-0801Total
Hispanic or Latino81523
Not Hispanic or Latino17926
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboORMD-0801Total
American Indian or Alaska Native000
Asian426
Native Hawaiian or Other Pacific Islander000
Black or African American8412
White131831
More than one race000
Unknown or Not Reported000
Childbearing Status
Childbearing Status(Participants)PlaceboORMD-0801Total
Not Applicable181432
Of Childbearing Potential000
Post Hysterectomy314
Surgically Sterilized246
At Least one year Post-Menopausal257
Height
Height(cm)PlaceboORMD-0801Total
Mean170.7 ± 9.96170.3 ± 11.50170.5 ± 10.74
Weight
Weight(Kg)PlaceboORMD-0801Total
Mean88.09 ± 14.63588.80 ± 16.54688.438 ± 15.604
Body Mass Index (BMI)
Body Mass Index (BMI)(Kg/m^2)PlaceboORMD-0801Total
Mean30.124 ± 3.580330.563 ± 3.783430.339 ± 3.6877
08

Study locations

1 site
  • Orange County Research Center (OCRC) 14351 Myford Rd., Suite B, Tustin, CA 92780
    Tustin, California 92780, United States
09

References and documents

Publications

  • Gastaldelli A, Baldi S, Pettiti M, Toschi E, Camastra S, Natali A, Landau BR, Ferrannini E. Influence of obesity and type 2 diabetes on gluconeogenesis and glucose output in humans: a quantitative study. Diabetes. 2000 Aug;49(8):1367-73. doi: 10.2337/diabetes.49.8.1367. PubMed 10923639 ↗
  • Ferrannini E, Gastaldelli A, Iozzo P. Pathophysiology of prediabetes. Med Clin North Am. 2011 Mar;95(2):327-39, vii-viii. doi: 10.1016/j.mcna.2010.11.005. PubMed 21281836 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2020 to primary completion in Jun 2022, 18 months.

Results were first posted in May 2024, 1 year 11 months after primary completion.

Of 194 industry-sponsored phase 2 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 18. This study's 18 months is above that.

Counting every sponsor, half of 293 studies reached it within 15 months; a quarter within 11 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2020
First posted
Sep 25, 2020
StartActual
Nov 23, 2020
Primary completionActual
Jun 7, 2022
CompletionActual
Jun 7, 2022
Results first posted
May 7, 2024
Last update
May 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04564846
Lead sponsor
Oramed, Ltd.
Responsible party
Sponsor
First posted
Sep 25, 2020
Start date
Nov 23, 2020
Primary completion
Jun 7, 2022
Completion
Jun 7, 2022
Results posted
May 7, 2024
Last update
May 7, 2024

Study contacts

Joel M Neutel, M. D.
principal investigator · Orange County Research Center (OCRC)
Ele Ferrannini, M. D.
principal investigator · CNR Institute of Clinical Physiology

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: ORMD-0801

Other studies in this condition

Diabetes Mellitus, Type 2 →

Other studies from this sponsor

Oramed, Ltd.

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