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

Phase IIa Multi-center, randomized, double-blind, placebo-controlled and parallel-designed study.

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.

Exclusion criteria

• Patients having received insulin, thiazolidinediones (TZDs) or non-thiazolidinedione hypoglycemic agents other than metformin or sulfonylurea agents within three months prior to screening
• Has had, within the last 6 months, evidence of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty (PTCA), congestive heart failure (New York Heart Association Class III-IV), or severe ischemic disease
• Patients who have an increased red blood cell (RBC) turn-over or Thalassemia or anemia
• Known HIV or history of viral hepatitis type B or C.
• Any type of diabetes other than Type 2 diabetes
• Significant hepatic enzyme elevation
• Body mass index (BMI) of > 40kg/m2
• Current or previous use of oral or injectable corticosteroids, or conditions that require the use of corticosteroids, during the three months prior to screening