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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
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.
Details
| Lead sponsor | Bellus Health Inc. - a GSK company |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 200 |
| Start date | 2008-04 |
| Completion | 2010-05 |
Conditions
- Diabetes Mellitus, Type 2
- Metabolic Syndrome X
Interventions
- NC-503 (eprodisate disodium)
- placebo
Primary outcomes
- Change from baseline to Week 26 in HbA1c levels — 26 weeks
Countries
Canada