MedTrace Logo

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

NCT00675857 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2010-08-24

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Bellus Health Inc. - a GSK company

    lead INDUSTRY

Principal Investigators

  • Jean-Louis Chiasson, MD · Hotel-Dieu du Centre Hospitalier de l'Université de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-01-31
Completion
2010-05-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00675857 on ClinicalTrials.gov