Diabetes Mellitus, Type 2
Conditions
Brief 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
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.
Interventions
OTHERPlacebo
Placebo capsule (Fish Oil)
DRUGORMD-0801
8 mg capsules of ORMD-0801 (Oral Insulin)
Sponsors
Oramed, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participant, Care Provider, and Investigator will be masked to the intervention (ORMD-0801 or placebo)
Intervention model description
The subject will receive either placebo or ORMD-0801
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects aged, 18 - 70 years. * Established diagnosis of T2DM for at least 6 months prior to Screening, with HbA1c ≥ 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. * Body mass index (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 - eGFR \> 30 ml/min/1.73 m2. * Females of childbearing potential must have a negative serum pregnancy test result at Screening.
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 creatinine clearance \< 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 New York Heart Association (NYHA) criteria, valvular heart disease, cardiac arrhythmia requiring treatment, pulmonary hypertension, cardiac surgery, history/occurrence of coronary angioplasty and/or stroke or transient ischemic attack (TIA) within 6 months prior to Screening. * Subjects with psychiatric disorders which, per investigator judgment, may have 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) glucocorticoid 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 upper limit of normal. 3. Elevated liver enzymes (alanine transaminase (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 hepatitis B or C, primary biliary cirrhosis, or active symptomatic gallbladder disease. * Positive history of HIV. * 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 immunosuppressive or immunomodulating agents. * Known allergy to soy. * Subject is on a weight loss program and is not in the maintenance phase, or subject has started weight loss medication (e.g., orlistat or liraglutide), within 8 weeks prior to Screening. * Subject has had bariatric surgery. * Subject is pregnant or 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 contraindications to metformin as per local label. * History of gastrointestinal disorders (e.g. hypochlorhydria) with the potential to interfere with drug absorption. * At the Principal Investigator's discretion, any condition or other factor that is deemed unsuitable for subject enrollment into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC(0-16)) of Endogenous Glucose Production | Day 28 (1 day) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Changes in HbA1c | baseline to Day 29 of the treatment period. | Mean Changes of HbA1c measured in percentage of glycated hemoglobin |
| Area Under the Curve AUC(0-16) of Metabolite Beta-hydroxybutyrate | Day 28 | 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. |
| Area Under the Curve (AUC) of Insulin | Day 28 (one day) | 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). |
| Area Under the Curve (AUC) of Free Fatty Acids (FFA) | Day 28 (one day) | 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). |
| Mean Changes Plasma Glucose Levels | baseline to Day 29 of the treatment period. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Placebo: Placebo capsule (Fish Oil) | 25 |
| 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.
ORMD-0801: 8 mg capsules of ORMD-0801 (Oral Insulin) | 24 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Principal Investigator requested that the patient withdraw from the study | 1 | 1 |
| Overall Study | Subject non-compliance | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | ORMD-0801 |
|---|---|---|---|
| Age, Continuous | 60.19 Years STANDARD_DEVIATION 6.497 | 59.45 Years STANDARD_DEVIATION 6.742 | 58.68 Years STANDARD_DEVIATION 6.904 |
| Body Mass Index (BMI) | 30.124 Kg/m^2 STANDARD_DEVIATION 3.5803 | 30.339 Kg/m^2 STANDARD_DEVIATION 3.6877 | 30.563 Kg/m^2 STANDARD_DEVIATION 3.7834 |
| Childbearing Status At Least one year Post-Menopausal | 2 Participants | 7 Participants | 5 Participants |
| Childbearing Status Not Applicable | 18 Participants | 32 Participants | 14 Participants |
| Childbearing Status Of Childbearing Potential | 0 Participants | 0 Participants | 0 Participants |
| Childbearing Status Post Hysterectomy | 3 Participants | 4 Participants | 1 Participants |
| Childbearing Status Surgically Sterilized | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 23 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 26 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 170.7 cm STANDARD_DEVIATION 9.96 | 170.5 cm STANDARD_DEVIATION 10.74 | 170.3 cm STANDARD_DEVIATION 11.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 12 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 31 Participants | 18 Participants |
| Sex: Female, Male Female | 7 Participants | 17 Participants | 10 Participants |
| Sex: Female, Male Male | 18 Participants | 32 Participants | 14 Participants |
| Weight | 88.09 Kg STANDARD_DEVIATION 14.635 | 88.438 Kg STANDARD_DEVIATION 15.604 | 88.80 Kg STANDARD_DEVIATION 16.546 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 3 / 25 | 6 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 |
Outcome results
Primary
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)
Population: modified intend-to-treat (mITT) population. mITT consists of all subjects that started on Day 28.~All 22 mITT placebo subjects came in for Study Day 28. One subject discontinued after the standard blood tests, prior to the pK measurements due to Non-Compliance or Lack of Cooperation. Thus, the sample size on Day 28 for AUC(0-16) is 21, and for the standard blood tests is 22. The 21 subjects that completed Visit 3 (days 28 + 29) were included in this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Curve (AUC(0-16)) of Endogenous Glucose Production | 3436.8 mg*hr/dL | Standard Deviation 922.89 |
| ORMD-0801 | Area Under the Curve (AUC(0-16)) of Endogenous Glucose Production | 3139.3 mg*hr/dL | Standard Deviation 830.29 |
Comparison: Comparison to Placebo Across All Time Pointsp-value: 0.162895% CI: [0.938, 1.011]Analysis of Covariance
Secondary
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
Population: modified intend-to-treat (mITT) population. mITT consists of all subjects that started on Day 28.~All 22 mITT placebo subjects came in for Study Day 28. One subject discontinued after the standard blood tests, prior to the pK measurements due to Non-Compliance or Lack of Cooperation. Thus, the sample size on Day 28 for AUC(0-16) is 21, and for the standard blood tests is 22. The 21 subjects that completed Visit 3 (days 28+ 29) were included in this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Curve AUC(0-16) of Metabolite Beta-hydroxybutyrate | 3435.8 umol*hr/L | Standard Deviation 3093.36 |
| ORMD-0801 | Area Under the Curve AUC(0-16) of Metabolite Beta-hydroxybutyrate | 2009.7 umol*hr/L | Standard Deviation 1659.04 |
Comparison: Estimated Difference from Placebo Across All Time Pointsp-value: 0.067495% CI: [0.605, 1.017]Analysis of Covariance
Secondary
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)
Population: modified intend-to-treat (mITT) population. mITT consists of all subjects that started on Day 28.~All 22 mITT placebo subjects came in for Study Day 28. One subject discontinued after the standard blood tests, prior to the pK measurements due to Non-Compliance or Lack of Cooperation. Thus, the sample size on Day 28 for AUC(0-16) is 21, and for the standard blood tests is 22. The 21 subjects that completed Visit 3 (days 28+29) were included in this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Curve (AUC) of Free Fatty Acids (FFA) | 7327.2 uEq*hr/L | Standard Deviation 1820.31 |
| ORMD-0801 | Area Under the Curve (AUC) of Free Fatty Acids (FFA) | 7051.4 uEq*hr/L | Standard Deviation 1788.71 |
p-value: 0.818295% CI: [0.951, 1.066]Analysis of Covariance
Secondary
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)
Population: modified intend-to-treat (mITT) population. mITT consists of all subjects that started on Day 28.~All 22 mITT placebo subjects came in for Study Day 28. One subject discontinued after the standard blood tests, prior to the pK measurements due to Non-Compliance or Lack of Cooperation. Thus, the sample size on Day 28 for AUC(0-16) is 21, and for the standard blood tests is 22. The 21 subjects that completed Visit 3 (days 28+29) were included in this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Curve (AUC) of Insulin | 324.8 uU*hr/mL | Standard Deviation 147.25 |
| ORMD-0801 | Area Under the Curve (AUC) of Insulin | 425.1 uU*hr/mL | Standard Deviation 274.61 |
Comparison: Estimated Difference from Placebo Across All Time Points.p-value: 0.818295% CI: [0.976, 1.167]Analysis of Covariance
Secondary
Mean Changes in HbA1c
Mean Changes of HbA1c measured in percentage of glycated hemoglobin
Time frame: baseline to Day 29 of the treatment period.
Population: modified intent-to-treat population (mITT). The mITT population consists of all subjects that started the Day 28 - 16 hour fast and corresponding measurements.~All 22 placebo subjects in the mITT population came in for Study Day 28 and started the fast. One subject discontinued prior to the Day 29 measurements due to Non-Compliance or Lack of Cooperation. This is why the Sample Size for Day 28 (and Baseline) is 22 while the Sample Size for Day 29 is 21.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Changes in HbA1c | Baseline HbA1c | 9.20 percentage of glycated hemoglobin | Standard Deviation 1.214 |
| Placebo | Mean Changes in HbA1c | Day 29 HbA1c | 9.19 percentage of glycated hemoglobin | Standard Deviation 1.196 |
| Placebo | Mean Changes in HbA1c | Difference of HbA1c between baseline and Day 29 | 0.08 percentage of glycated hemoglobin | Standard Deviation 0.452 |
| ORMD-0801 | Mean Changes in HbA1c | Baseline HbA1c | 8.51 percentage of glycated hemoglobin | Standard Deviation 1.401 |
| ORMD-0801 | Mean Changes in HbA1c | Day 29 HbA1c | 8.67 percentage of glycated hemoglobin | Standard Deviation 1.319 |
| ORMD-0801 | Mean Changes in HbA1c | Difference of HbA1c between baseline and Day 29 | 0.15 percentage of glycated hemoglobin | Standard Deviation 0.637 |
Secondary
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.
Population: modified intent-to-treat population (mITT). The mITT population consists of all subjects that started the Day 28 - 16 hour fast and corresponding measurements.~All 22 placebo subjects in the mITT population came in for Study Day 28 and started the fast. One subject discontinued prior to the Day 29 measurements due to Non-Compliance or Lack of Cooperation. This is why the Sample Size for Day 28 (and Baseline) is 22 while the Sample Size for Day 29 is 21
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Changes Plasma Glucose Levels | Plasma Glucose at Baseline | 216.4 mg/dL | Standard Deviation 55.37 |
| Placebo | Mean Changes Plasma Glucose Levels | Plasma Glucose at Day 29 | 192.7 mg/dL | Standard Deviation 51.62 |
| Placebo | Mean Changes Plasma Glucose Levels | Change in Plasma Glucose from Baseline | -19.6 mg/dL | Standard Deviation 46.61 |
| ORMD-0801 | Mean Changes Plasma Glucose Levels | Plasma Glucose at Baseline | 187.5 mg/dL | Standard Deviation 48.6 |
| ORMD-0801 | Mean Changes Plasma Glucose Levels | Plasma Glucose at Day 29 | 167.9 mg/dL | Standard Deviation 48.58 |
| ORMD-0801 | Mean Changes Plasma Glucose Levels | Change in Plasma Glucose from Baseline | -19.6 mg/dL | Standard Deviation 39.68 |