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

A Phase IIa Study of the Safety and Clinical Proof-of-concept of NC-503 (Eprodisate Disodium) in Patients With Type II Diabetes and Features of Metabolic Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome X
• Intervention / Treatment: Other: placebo; Drug: NC-503 (eprodisate disodium)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 0M3
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
  • Ontario
    • Etobicoke, Ontario, Canada, M9R 4E1
    • London, Ontario, Canada, N6A 4V2
    • Oakville, Ontario, Canada, L6H 3P1
    • Ottawa, Ontario, Canada, K1H 1A2
    • Ottawa, Ontario, Canada, K1K 4L2
    • Thornhill, Ontario, Canada, L4J 8L7
    • Toronto, Ontario, Canada, M5C 2T2
    • Toronto, Ontario, Canada, M4R 2G4
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
    • Greenfield Park, Quebec, Canada, J4V 2H1
    • Laval, Quebec, Canada, H7T 2P5
    • Montreal, Quebec, Canada, H1T 2M4
    • Montreal, Quebec, Canada, H2W 1T7
    • Montréal, Quebec, Canada, H3A 1A1
    • Montréal, Quebec, Canada, H3H 2L9
    • Montréal, Quebec, Canada, H3N 1S4
    • Québec, Quebec, Canada, G1V 4G5
    • Sherbrooke, Quebec, Canada, J1H 5N4
    • Sherbrooke, Quebec, Canada, J1G 1B8

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B	Drug: NC-503 (eprodisate disodium); capsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks
Placebo Comparator: A	Other: placebo; Dosage: 4 capsules BID for 26 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to Week 26 in HbA1c levels	26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c levels	26 weeks
The rate of achieving glycemic control	26 weeks
Change in fasting serum glucose levels	26 weeks

Collaborators and Investigators

• Sponsor: Bellus Health Inc
• Investigators: Principal Investigator: Jean-Louis Chiasson, MD, Hotel-Dieu du Centre Hospitalier de l'Université de Montréal

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: May 8, 2008
• First Submitted That Met QC Criteria: May 8, 2008
• First Posted (Estimate): May 12, 2008

Study Record Updates

• Last Update Posted (Estimate): August 24, 2010
• Last Update Submitted That Met QC Criteria: August 23, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Type II diabetes
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease; Insulin Resistance; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: CL-503011