Status:
TERMINATED
The LANCET Trial: A Trial of Long-acting Insulin Injection to Reduce C-reactive Protein in Patients With Type 2 Diabetes
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Sanofi
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-79 years
Phase:
PHASE4
Brief 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 me...
Detailed Description
Study Rationale Low-grade systemic inflammation as indicated by elevated levels of C-reactive protein (CRP) is often present in patients with type 2 diabetes. Individuals with type 2 diabetes represe...
Eligibility Criteria
Inclusion
- Men and women aged 18 to 79
- Type 2 diabetes, treated only by diet or oral drugs other than metformin
- HbA1c greater than or equal to 7% and less than or equal to 10%
- C-reactive protein greater than or equal to 2 mg/L
Exclusion
- Baseline use of metformin or insulin
- Type 1 diabetes, history of ketoacidosis or positive anti-GAD antibody
- History of congestive heart failure requiring drug therapy
- Active liver disease
- Kidney impairment
- Recent initiation or change in dose of statins, fibric acid derivatives, angiotensin receptor blockers, nonsteroidal anti-inflammatory agents, or corticosteroids
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00366301
Start Date
August 1 2006
End Date
April 1 2009
Last Update
November 25 2010
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215