Type 2 Diabetes Clinical Trial
Official title:
The LANCET Trial: A Randomized Clinical Trial of Lantus for C-reactive Protein Reduction in Early Treatment of Type 2 Diabetes
Verified date | October 2010 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 500 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 79 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Sanofi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage Reduction in C-reactive Protein (CRP) | 14 weeks | No |
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