A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 1

In brief

This will be a prospective, randomized, double-blind, placebo controlled study. Patients with established Type 1 diabetes will be eligible for entry into the study. Eligible patients will be screened and those who fulfill all inclusion/exclusion criteria will be admitted to the inpatient unit no fewer than 2 days and no more than 7 days after Screening. Patients will report to the inpatient unit at 6 a.m. and outfitted with a continuous glucose monitoring (CGM) device. Patients will be given standardized meals and snacks for the duration of their inpatient visit.

Key facts

Study ID

NCT02094534

Run by

Oramed, Ltd.

People needed

25

Starts

2014-03-01

Expected to finish

2014-10-01

Last updated by the study team

2017-07-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and Females age 18 to 55 years old, inclusive.
• Patients must be willing and able to sign informed consent.
• Documented history of Type 1 Diabetes for at least 6 months
• Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urinary screening test following admission to the inpatient unit

You may not qualify if…

• 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)
• Fasting plasma glucose >260 mg/dL at the end of run-in
• Evidence of unawareness of hypoglycemia with a documented plasma glucose ≤50 mg/dL in the absence of symptoms of hypoglycemia
• Presence of any clinically significant condition that might interfere with the evaluation of study medication (i.e., significant renal, hepatic, gastrointestinal (GI), cardiovascular (CV), immune disease).
• 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:
• Positive pregnancy test in females of childbearing potential (at screening and Day -3 of Visit 2)
• Abnormal serum thyrotropin (TSH) levels >1.5X upper limit of normal (ULN)
• Positive test for hepatitis B surface antigen and/or hepatitis C antibody
• Positive test for HIV
• Any relevant abnormality interfering with the efficacy or the safety assessments during study drug administration
• Use of the following medications:
• o History of use of aprotinin at any time prior to the screening visit (e.g., Trasylol, any type or dose)
• Administration of thiazolidinedione [e.g., (Actos (pioglitazone) and Avandia (rosiglitazone)] treatment within 3 months prior to randomization.
• Administration of thyroid preparations or thyroxine (except in patients on stable replacement therapy) within 6 weeks prior to screening visit
• 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 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 severe or multiple allergies, or known allergy to soy or aprotinin.
• History of tobacco or nicotine use within 10 weeks prior to screening
• Patient is on a weight loss program and is not in the maintenance phase, or patient that started weight loss medication (e.g., orlistat or sibutramine) within 8 weeks prior to screening
• Pregnancy or breast-feeding
• Patient has a screening visit systolic blood pressure of ≥165 mmHg or diastolic blood pressure of ≥100 mmHg.
• Patient is, at the time of 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 2 times the upper limit of normal (ULN) at Screening
• Very high triglyceride level (>600 mg/dL) at Screening

Where it is running

• Orange County Research Center — Tustin, California, United States

Full record on ClinicalTrials.gov

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