A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes
NCT ID: NCT00675857
Last Updated: 2010-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2008-04-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
placebo
Dosage: 4 capsules BID for 26 weeks
B
NC-503 (eprodisate disodium)
capsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks
Interventions
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NC-503 (eprodisate disodium)
capsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks
placebo
Dosage: 4 capsules BID for 26 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
95 Years
ALL
No
Sponsors
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Bellus Health Inc. - a GSK company
INDUSTRY
Responsible Party
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Bellus Health Inc.
Principal Investigators
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Jean-Louis Chiasson, MD
Role: PRINCIPAL_INVESTIGATOR
Hotel-Dieu du Centre Hospitalier de l'Université de Montréal
Locations
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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
Countries
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Other Identifiers
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CL-503011
Identifier Type: -
Identifier Source: org_study_id
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