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

NCT00675857 | Completed Phase 2

• 1 other identifier: CL-503011
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 21

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 treated with either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent.

Conditions

Diabetes Mellitus, Type 2; Metabolic Syndrome X

Keywords

Type II diabetes; Metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Change from baseline to Week 26 in HbA1c levels

  26 weeks

Secondary Outcomes (3)

• Change in HbA1c levels

  26 weeks

• The rate of achieving glycemic control

  26 weeks

• Change in fasting serum glucose levels

  26 weeks

Study Arms (2)

A

PLACEBO COMPARATOR

Other: placebo

B

ACTIVE COMPARATOR

Drug: NC-503 (eprodisate disodium)

Interventions

NC-503 (eprodisate disodium) DRUG

capsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks

B

placebo OTHER

Dosage: 4 capsules BID for 26 weeks

A

Eligibility Criteria

• Age: 30 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bellus Health Inc. - a GSK company: lead

Study Sites (21)

Unknown Facility

Calgary, Alberta, T3B 0M3, Canada

Location

Unknown Facility

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Unknown Facility

Etobicoke, Ontario, M9R 4E1, Canada

Location

Unknown Facility

London, Ontario, N6A 4V2, Canada

Location

Unknown Facility

Oakville, Ontario, L6H 3P1, Canada

Location

Unknown Facility

Ottawa, Ontario, K1H 1A2, Canada

Location

Unknown Facility

Ottawa, Ontario, K1K 4L2, Canada

Location

Unknown Facility

Thornhill, Ontario, L4J 8L7, Canada

Location

Unknown Facility

Toronto, Ontario, M4R 2G4, Canada

Location

Unknown Facility

Toronto, Ontario, M5C 2T2, Canada

Location

Unknown Facility

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Unknown Facility

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Unknown Facility

Laval, Quebec, H7T 2P5, Canada

Location

Unknown Facility

Montreal, Quebec, H1T 2M4, Canada

Location

Unknown Facility

Montreal, Quebec, H2W 1T7, Canada

Location

Unknown Facility

Montreal, Quebec, H3A 1A1, Canada

Location

Unknown Facility

Montreal, Quebec, H3H 2L9, Canada

Location

Unknown Facility

Montreal, Quebec, H3N 1S4, Canada

Location

Unknown Facility

Québec, Quebec, G1V 4G5, Canada

Location

Unknown Facility

Sherbrooke, Quebec, J1G 1B8, Canada

Location

Unknown Facility

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• Jean-Louis Chiasson, MD

  Hotel-Dieu du Centre Hospitalier de l'Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 12, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 24, 2010

Record last verified: 2010-08

Locations

CA (21)