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

CompletedPhase 2

Sponsor: Bellus Health Inc. - a GSK company

Conditions: Diabetes Mellitus, Type 2, Metabolic Syndrome X

Interventions: NC-503 (eprodisate disodium), placebo

Countries: Canada

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.

Eligibility overview

Sex: ALL

Age: 30 Years to 95 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (21)

Calgary, Alberta, Canada
Winnipeg, Manitoba, Canada
Etobicoke, Ontario, Canada
London, Ontario, Canada
Oakville, Ontario, Canada
Ottawa, Ontario, Canada
Ottawa, Ontario, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Greenfield Park, Quebec, Canada
Laval, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Sherbrooke, Quebec, Canada