Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-29 @ 12:03 PM
Study NCT ID:
NCT00675857
Status:
COMPLETED
Last Update Posted:
2010-08-24
First Post:
2008-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes
Sponsor:
Bellus Health Inc. - a GSK company
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Phase IIa Multi-center, randomized, double-blind, placebo-controlled and parallel-designed study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: