Status:
COMPLETED
A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes
Lead Sponsor:
Bellus Health Inc. - a GSK company
Conditions:
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Eligibility:
All Genders
30-95 years
Phase:
PHASE2
Brief 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...
Detailed Description
Phase IIa Multi-center, randomized, double-blind, placebo-controlled and parallel-designed study.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00675857
Start Date
April 1 2008
End Date
May 1 2010
Last Update
August 24 2010
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Calgary, Alberta, Canada, T3B 0M3
2
Winnipeg, Manitoba, Canada, R3E 3P4
3
Etobicoke, Ontario, Canada, M9R 4E1
4
London, Ontario, Canada, N6A 4V2