A Phase IIa Proof-of-Concept Study of NC-503 in Patients With Type II Diabetes - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2 Metabolic Syndrome X	Drug: NC-503 (eprodisate disodium) Other: placebo	Phase II

MedlinePlus related topics:

Diabetes Metabolic Syndrome

Drug Information available for:

Eprodisate Disodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by Bellus Health Inc:

Primary Outcome Measures:

Change from baseline to Week 26 in HbA1c levels [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in HbA1c levels [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
The rate of achieving glycemic control [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change in fasting serum glucose levels [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	April 2008
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator	Other: placebo Dosage: 4 capsules BID for 26 weeks
B: Active Comparator	Drug: NC-503 (eprodisate disodium) capsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks

Detailed Description:

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

Eligibility

Ages Eligible for Study:	30 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675857

Contacts


Contact: Information Center	450-680-4500	PIC@bellushealth.com

Contact: Francis Gauthier, M.Sc.	450-680-4449	fgauthier@bellushealth.com

Locations


Canada, Alberta
		Recruiting
	Calgary, Alberta, Canada, T3B 0M3

Canada, Manitoba
		Recruiting
	Winnipeg, Manitoba, Canada, R3E 3P4

Canada, Ontario
		Recruiting
	Ottawa, Ontario, Canada, K1K 4L2
		Recruiting
	Thornhill, Ontario, Canada, L4J 8L7
		Recruiting
	Toronto, Ontario, Canada, M4R 2G4
		Not yet recruiting
	Ottawa, Ontario, Canada, K1H 1A2
		Recruiting
	Etobicoke, Ontario, Canada, M9R 4E1
		Not yet recruiting
	London, Ontario, Canada, N6A 4V2
		Recruiting
	Toronto, Ontario, Canada, M5C 2T2
		Recruiting
	Oakville, Ontario, Canada, L6H 3P1

Canada, Quebec
		Active, not recruiting
	Montréal, Quebec, Canada, H3H 2L9
		Recruiting
	Sherbrooke, Quebec, Canada, J1G 5K2
	Contact: , MD
		Recruiting
	Montreal, Quebec, Canada, H2W 1T7
		Recruiting
	Chicoutimi, Quebec, Canada, G7H 5H6
		Recruiting
	Sherbrooke, Quebec, Canada, J1H 5N4
		Not yet recruiting
	Greenfield Park, Quebec, Canada, J4V 2H1
		Recruiting
	Québec, Quebec, Canada, G1V 4G5
		Recruiting
	Montreal, Quebec, Canada, H1T 2M4
		Not yet recruiting
	Montréal, Quebec, Canada, H3A 1A1
		Not yet recruiting
	Montréal, Quebec, Canada, H3N 1S4
		Recruiting
	Laval, Quebec, Canada, H7T 2P5

Sponsors and Collaborators

Bellus Health Inc

Investigators


Principal Investigator:	Jean-Louis Chiasson, MD	Hotel-Dieu du Centre Hospitalier de l'Université de Montréal

More Information

Responsible Party:	Bellus Health Inc. ( Francis Gauthier, Project Manager )
Study ID Numbers:	CL-503011
First Received:	May 8, 2008
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00675857
Health Authority:	Canada: Health Canada

Keywords provided by Bellus Health Inc:

Type II diabetes

Metabolic syndrome

Study placed in the following topic categories:

Hyperinsulinism

Metabolic Diseases

Metabolic Syndrome X

Diabetes Mellitus, Type 2

Syndrome X

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Insulin Resistance

Metabolic disorder

Glucose Metabolism Disorders

Abdominal obesity metabolic syndrome

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

ClinicalTrials.gov processed this record on October 23, 2008

Sponsored by:	Bellus Health Inc
Information provided by:	Bellus Health Inc
ClinicalTrials.gov Identifier:	NCT00675857