NCT00675857

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Bellus Health Inc. - a GSK company · Industry
• Sex: All
• Age: 30 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Diabetes Mellitus, Type 2
• Metabolic Syndrome X

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-01-01
• Completion: 2010-05-01
• First posted: 2008-05-12
• Last updated: 2010-08-24

Locations

21 sites across 1 country: Canada