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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objectives of the current study are to establish the safety and clinical proof-of-concept of NC-503 in inadequately controlled patients with Type 2 diabetes and features of metabolic syndrome treated with either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bellus Health Inc

Criteria

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