Study to Evaluate the Safety and Tolerability of PBI-4050 in Type 2 Diabetes Patients With Metabolic Syndrome

This Phase 2 study will be performed by 1 site in Canada. The total duration of study participation for each patient is at least 18 weeks and comprises 6 study visits.

Patients who choose to participate in the extension study will be in the study for a total of up to 32 weeks.

Inclusion criteria

• Patient is 18 years of age or older.
• Patient has signed written informed consent.
• Patient has a clinical diagnosis of type 2 diabetes mellitus with a hemoglobin A1c (HbA1c) level between 7% and 10%.
• Patient has been receiving stable antidiabetic therapy (oral agents with or without basal insulin given once daily in the evening) for a minimum of 3 months before the screening visit.
• Patient is able and willing to self-monitor blood glucose level at home.
• Patient has a body mass index (BMI) of at least 27 kg/m2.
• Patient has metabolic syndrome, having at least 3 of the 5 metabolic syndrome risk factors.

Exclusion criteria

• Patient requires intensive insulin therapy (defined as more than basal insulin given once daily in the evening) in addition to oral hypoglycemic agents for blood glucose control.
• Patient has recent or on-going infection requiring systemic treatment with an anti-infective agent within 30 days before screening.
• Patient has had at least one episode of severe hypoglycemia in the past 12 months, defined as having a blood glucose level < 3.0 mmol/L and/or requiring third party assistance to treat hypoglycemic episode.
• Patient has evidence of significant cardiovascular disease, including myocardial infarction, unstable angina, coronary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), congestive heart failure (New York Heart Association Class III-IV), stroke, or severe ischemic disease within 3 months before screening.
• Patient has uncontrolled hypertension with BP > 150/95 mm Hg.
• Patient has a diagnosis of rheumatic or inflammatory disease, such as rheumatoid arthritis (RA), polymyalgia rheumatic (PMR), inflammatory bowel disease (IBD); or other autoimmune or inflammatory disease such as systemic lupus erythematosus (SLE) or psoriasis.
• Patient is concurrently taking and plans to routinely continue taking anti-inflammatory medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids, during the study.
• Patient is currently using weight loss medications.
• Patient has significantly elevated liver enzyme levels, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × upper limit of normal (ULN) or total bilirubin above ULN.
• Patient has a history of chronic alcohol or other substance abuse.
• Woman who is pregnant, breast-feeding, or planning a pregnancy during the course of the study.
• Woman of childbearing potential who is unwilling to use adequate birth control throughout the duration of the study.
• Patient has any condition that, in the investigator's opinion, is likely to interfere with study conduct and compliance.