Campanian Postprandial Hyperglycemia Study - Campanian Postprandial Hyperglycemia Study

Aug 30, 2004
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Date Published:
01/01/2004
Date Updated:
08/30/2004
Original Posted Date:
08/30/2004
References

Description:

The goal of the trial was to evaluate the effect of repaglinide and glyburide, insulin secretagogues known to have different efficacy on postprandial hyperglycemia, on carotid intima-media thickness (CIMT) and markers of systemic vascular inflammation in type 2 diabetic patients.

Study Design

Study Design:

Patients Screened: 210
Patients Enrolled: 175
Mean Follow Up: 12 months
Mean Patient Age: Mean age 52 years
Female: 47

Patient Populations:

Diagnosis of type 2 diabetes for ≥6 months but <3 years, age 35-70 years, body mass index of ≥24, a value of HbA1c ≥6.5%, and treated with diet or oral drugs

Exclusions:

Need for insulin use; concomitant chronic diseases, including kidney, liver, and cardiovascular diseases; recent acute illness or change in diet, treatment, or lifestyle within three months before the study; severe uncontrolled hypertension (blood pressure >200/100 mm Hg); and women who were pregnant or intended to become pregnant

Primary Endpoints:

CIMT at 12-month follow-up

Drug/Procedures Used:

Patients were randomized in an open-label manner to treatment with either repaglinide (n=88; 1.5, 3, 6, and 12 mg) or glyburide (n=87; 5, 10, 15, and 20 mg). Study drugs were titrated during a six- to eight-week period, and treatment was continued through 12 months.

Principal Findings:

At study completion, the majority of patients were at dose level 4 (59%) and the dose level did not differ by treatment group. At the end of the study, the area under the curve for glucose was 2370 mg/dl•2 h in the repaglinide group and 4020 mg/dl•2 h in the glyburide group (p=0.01). A fasting glucose level <110 mg/dl was achieved more frequently in the glyburide group versus the repaglinide group (24% vs. 48%, p=0.01). Postprandial glucose peak was lower in the repaglinide group versus the glyburide group (148 mg/dl vs. 180 mg/dl, p<0.01).

There was no difference in HbA1c reductions, which decreased by 0.9% in both groups. Reductions in C-reactive protein were greater in the repaglinide arm (-0.7 vs. -0.2 mg/l, p=0.02), as were reductions in interleukin-6 (-0.5 vs. -0.2, p=0.04). Reduction from baseline in CIMT was larger in the repaglinide arm (-0.029 mm vs. -0.005 mm, p=0.02). CIMT regression, defined as a decrease of >0.020 mm, occurred in more patients in the repaglinide arm versus the glyburide arm (52% vs. 18%, p<0.01).

Interpretation:

Among type 2 diabetic patients, treatment with repaglinide was associated with a regression in CIMT from baseline, while there was no change in CIMT in patients treated with glyburide. Repaglinide is a rapid-onset but short duration insulinotropic agent that selectively increases meal-related early insulin secretion and may result in better control of postprandial hyperglycemia than glyburide, which is a long-acting sulfonylurea. The authors note that at the same level of HbA1c, amelioration of postprandial glucose peaks with repaglinide was more effective in reducing CIMT at one year than amelioration of fasting hyperglycemia with glyburide.

Limitations of the study include the single-center and open-label design, although the CIMT was assessed by a reviewer blinded to treatment assignment.

References:

Esposito K, Giugliano D, Nappo F, Marfella R. Regression of carotid atherosclerosis by control of postprandial hyperglycemia in type 2 diabetes mellitus. Circulation 2004;110:214-9.

Keywords: Carbamates, Inflammation, Insulin, Hyperglycemia, Carotid Intima-Media Thickness, Interleukin-6, Diabetes Mellitus, Type 2, Glucose, C-Reactive Protein, Piperidines, Body Mass Index, Fasting, Glyburide


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