Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:20 - 75
Updated:2/8/2018
Start Date:June 2015
End Date:April 2016

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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.

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.

Inclusion Criteria:

- 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.

- 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.

Exclusion Criteria:

- 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:

1. C-peptide < 1.0 ng/mL.

2. Positive pregnancy test in females of childbearing potential (at screening and
start of run-in period).

3. Abnormal serum thyrotropin (TSH) levels >1.5 times the upper limit of normal.

4. Positive test for hepatitis B surface antigen and/or hepatitis C antibody.

5. Positive test for HIV.

6. Serum Cr >1.4mg/dl in males, >1.3mg/dl in females.

7. Any relevant abnormality interfering with the efficacy or the safety assessments
during study drug administration.

- Use of the following medications:

1. 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.

2. 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:

1. History of stroke, transient ischemic attack, or myocardial infarction within six
months prior to screening,

2. History of or currently have New York Heart Associate Class II-IV heart failure
prior to screening, or

3. Uncontrolled hypertension defined as blood pressure ≥160 mmHg (systolic) or ≥100
mmHg (diastolic) at screening.
We found this trial at
33
sites
760 North Euclid Street
Anaheim, California 92801
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Anaheim, CA
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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Clearwater, FL
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30 Pointe Circle
Greenville, South Carolina 29615
(864)255-3540
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Greenville, SC
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
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Los Angeles, CA
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77 West Granada Boulevard
Ormond Beach, Florida 32174
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Ormond Beach, FL
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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San Antonio, TX
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Wichita, KS
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Auburn, Maine 04210
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Auburn, ME
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Bradenton, Florida
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Bradenton, FL
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Brooksville, Florida
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Corpus Christi, Texas 78404
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Denver, Colorado 80209
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Flint, Michigan 48504
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Flint, MI
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1055 East 4th Avenue
Hialeah, Florida 33013
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Hialeah, FL
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Las Vegas, Nevada 89106
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Las Vegas, NV
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Little Rock, Arkansas 72204
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Little Rock, AR
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Los Angeles, California 90017
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Los Angeles, CA
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Los Angeles, California 90017
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Miami, Florida 33165
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Miami, FL
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875 Ellicott Street
New York, New York 10018
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New York, NY
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Norman, Oklahoma 73069
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Norman, OK
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North Hollywood, California 91606
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North Hollywood, CA
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Phoenix, Arizona 85015
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Renton, Washington 98057
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Renton, WA
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Salt Lake City, Utah 84107
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San Antonio, Texas 78215
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San Antonio, Texas 78221
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San Antonio, Texas 78228
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San Mateo, California 94401
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5115 North Armenia Avenue
Tampa, Florida 33603
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Tampa, Florida
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Tustin, California
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West Palm Beach, Florida
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West Palm Beach, FL
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