A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes

Inclusion Criteria

• •Age and gender eligibility: 30 years and older
• •Diagnosis of Type 2 diabetes mellitus
• •Patients treated with a stable therapeutic dose of either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent for a minimum period of 3 months prior to the Screening visit
• •Patients must have HbA1C level between 7.0-10.0 %, inclusively at screening
• •The participant must have central obesity (Waist circumference) defined per country/ethnic group: Europids: men ≥ 94 cm, women ≥ 80 cm; South Asian, Chinese \& Japanese: men ≥ 90 cm, women ≥ 80 cm; and any one of the following metabolic syndrome characteristics at screening:
• •Reduced HDL cholesterol ≤ 1.0 mmol/L
• •Hypertriglyceridemia ≥ 1.7 mmol/L or treatment for dyslipidemia
• •Hypertension: ≥ 130/85 mm Hg blood pressure or treatment with antihypertensive medication.
• •Patients must have a Glomerular Filtration Rate (GFR) of ≥ 60 mL/min, and no history of dialysis.