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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675857
• Other study ID #: CL-503011
• Status: Completed
• Phase: Phase 2
• First received: May 8, 2008
• Last updated: August 23, 2010
• Start date: April 2008
• Est. completion date: May 2010

Study information

• Verified date: August 2010
• Source: Bellus Health Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 95 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Metabolic Syndrome X

Intervention

Drug:
• NC-503 (eprodisate disodium)
capsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks

Other:
• placebo
Dosage: 4 capsules BID for 26 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bellus Health Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to Week 26 in HbA1c levels		26 weeks	No
Secondary	Change in HbA1c levels		26 weeks	No
Secondary	The rate of achieving glycemic control		26 weeks	No
Secondary	Change in fasting serum glucose levels		26 weeks	No