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

NCT00366301 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2010-11-25

Study results available
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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.

Conditions

Interventions

DRUG

Insulin glargine injection

Once daily for 14 weeks

DRUG

metformin

Up to 4 pils per day (2g per day) maximum

DRUG

Placebo pill

Up to 4 pills per day

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Paul M Ridker, MD, MPH · Brigham and Women's Hospital

  • Aruna Das Pradhan, MD, MPH · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00366301 on ClinicalTrials.gov