A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus

Completed · Phase 2 · Has a placebo group

Conditions studied: T2DM (Type 2 Diabetes Mellitus)

In brief

This is a four-way (Participant, Care Provider, Investigator, Outcomes Assessor) masked (blinded) study designed to explore the efficacy of ORMD-0801 when given in different regimens across a dose range for up to 12 weeks in subjects with type 2 diabetes mellitus (T2DM).

Key facts

Study ID

NCT03467932

Run by

Oramed, Ltd.

People needed

373

Starts

2018-05-29

Expected to finish

2020-02-18

Last updated by the study team

2022-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects aged 18 and older.
• Established diagnosis of T2DM for at least 6 months prior to Screening, with an HbA1C (glycated hemoglobin) ≥ 7.5%.
• Stable dose of metformin (at least 1500 mg or maximally tolerated dose)/oral antidiabetic (OAD) 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 (DiPeptidyl Peptidase-4), SGLT-2 (Sodium-GLucose coTransporter-2), or TZD (Thiazolidinediones).
• Body mass index (BMI) of up to 40 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 (estimated glomerular filtration rate) > 30 ml/min/1.73 m2
• Females of childbearing potential must have a negative serum pregnancy test result at Screening.

You may not qualify if…

• Subjects with insulin-dependent diabetes
• 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).
• 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:
• 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.
• Renal dysfunction: eGFR < 30 ml/min/1.73 m2
• History of proliferative retinopathy or severe form of neuropathy or cardiac autonomic neuropathy (CAN)
• 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
• 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 an impact on the safety of the subject or interfere with the 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.
• 9. Laboratory abnormalities at Screening include:
• C-peptide < 1.0 ng/mL
• Abnormal serum thyrotropin (TSH) levels below the lower limit of normal or >1.5X the upper limit of normal
• Elevated liver enzymes (alanine transaminase (ALT), alanine aminotransferase (AST), alkaline phosphatase) >2X the upper limit of normal.
• Very high triglyceride levels (>600 mg/dL); a single repeat test is allowable.
• Any relevant abnormality that would interfere with the efficacy or the safety assessments during the 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:
• History of any basal, pre-mix or prandial insulin (greater than 7 days) within 6 months prior to Screening.

Where it is running

• AA MRC — Flint, Michigan, United States

Full record on ClinicalTrials.gov

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