drugset / Trial / NCT00366301

The LANCET Trial: A Trial of Long-acting Insulin Injection to Reduce C-reactive Protein in Patients With Type 2 Diabetes

NCT00366301 ↗

Phase 4 Terminated 500 enrolled Brigham and Women's Hospital Sanofi · collab
RandomizedFactorialOpen-labelTreatment

Summary

The purpose of this study, which is being conducted at 100 centers throughout the United States, is to determine whether Lantus, a long-acting insulin injection, either alone or in combination with metformin, is effective in reducing C-reactive protein (CRP) in adults with type 2 diabetes. CRP is a marker of chronic low-level inflammation, a new risk factor for diabetes, heart attack, stroke, and other cardiovascular events.

Timeline

Start
2006-08
Primary completion
2009-04
Completion
2009-04

Outcome

Outcome not reported

Stopped (Enrollment): “Interim analyses demonstrated futility. Thus, recruitment curtailed 10/08.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 2 g —
Comparator insulin glargine Protein / enzyme biologic — —