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
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.
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
represent a vulnerable population in which cardiovascular event rates are high and among
whom CRP reduction may have the greatest impact. While several classes of oral hypoglycemic
agents have been shown to lower CRP, data are not available for newer formulations of
long-acting insulins such as Lantus (insulin glargine injection) and no study has
comprehensively evaluated the relative merit of insulin-providing versus insulin-sensitizing
strategies for this purpose.
Investigational Plan
This is a multicenter, community-based, randomized 2x2 factorial trial of Lantus and
metformin among patients with type 2 diabetes treated with either diet or oral monotherapy
(other than metformin) only who have poor glycemic control and elevated CRP. The primary
endpoint is change in CRP. Secondary endpoints include improvement in insulin sensitivity,
glycemic control, blood lipids, as well as selected inflammatory and prothrombotic markers,
and adipokine levels.
Limited data suggest that short-term insulin administration in patients with poorly
controlled type 2 diabetes may lower CRP, but the benefit of CRP reduction that is unique to
insulin therapy and independent of glycemic control per se remains uncertain. The
insulin-sensitizing agent metformin, a mainstay of anti-diabetic therapy, has been shown to
reduce macrovascular complications among patients with type 2 diabetes and, in some but not
all randomized clinical trials, also has a modest CRP-lowering effect. This study is
designed to assess whether the use of Lantus either alone or in combination with metformin
lowers CRP over a 14-week treatment period.
Eligible men and women age 18 to 79 years with early diabetes on diet only or oral
monotherapy with baseline HbA1c 7.0-10% and CRP greater than or equal to 2.0 mg/l will be
randomized in a 2X2 factorial fashion as follows. First, participants will be assigned at
random to open-label Lantus or no insulin. Then, within these two categories, subjects will
be assigned at random to metformin or placebo. Thus, the four resultant treatment groups are
Lantus injection and placebo pill, Lantus injection and metformin pill, metformin pill
alone, and placebo pill alone. All patients will receive diet and exercise counseling.
This study design will permit testing of the overall effect of Lantus as well as the effect
of combination therapy with metformin for CRP reduction at a targeted level of glycemic
control (fingerstick fasting blood glucose < 110 mg/dl). All participants will be provided
with a glucometer for fingerstick glucose testing calibrated to report plasma-referenced
values.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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