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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT00366301

Run by

Brigham and Women's Hospital

People needed

500

Starts

2006-08-01

Expected to finish

2009-04-01

Last updated by the study team

2010-11-25

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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