Lancet Trial
A randomized Clinical Trial of Lantus® for C-Reactive Protein Reduction in Early Treatment of Type 2 Diabetes.
Purpose
The purpose of this study is to determine whether LantusÒ, 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.
Study Design
Will permit testing of the overall effect of LantusÒ as well as the effect of combination therapy with metformin for CRP reduction at a targeted level of glycemic control (fingerstick fasting blood glucose < 110mg). All subjects will be provided with a glucometer for fingerstick glucose testing calibrated to report plasma-referenced values.
The study population will include those who meet the following inclusion/exclusion criteria, some of which are:
Inclusion criteria
- Demographics: 18 to 79 years of age men and women.
- Type 2 Diabetes, treated only by diet or oral drugs other than metformin.
- Subject has a glucose level (HbA1c) ≥ 7.0% and ≤ 10%.
- C-Reactive Protein (CRP) ≥ 2 MG.
- Signed & dated, written informed consent to participate in this study.
Exclusion criteria
- Baseline use of metformin or insulin
- Type 1 Diabetes, history of katecidosis 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, nonsteriodial anti-inflammatory agents, or corticosteriods.
To inquire if you are eligible for this study or hear more about it, please contact:
Lori Brazee
Clinical Research
Office#: 781-505-8710
Email: lbrazee@pchi.partners.org
