Effects of Sitagliptin on Glycemic Control and Lipoprotein Metabolism (GLORIA) - Effects of Sitagliptin on Glycemic Control and Lipoprotein Metabolism (GLORIA)
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
In patients with type II diabetes mellitus, fasting and postprandial hypertriglyceridemia (PHTG) is complicated. PHTG is supposed to be caused by the postprandial accumulation of remnant lipoproteins (VLDL remnants and chylomicron remnants), which are highly atherogenic. In the current study, we investigated whether the sitagliptin might ameliorate the impaired lipoprotein metabolism in patients with type II diabetes mellitus. We enrolled 38 patients with type II diabetes mellitus whose HbA1c levels were less than 8.4% and all patients gave written informed consents. The oral administration of sitagliptin(50mg/day) were started in addition to the current anti-diabetic treatments. The daily dose of sitagliptin was allowed to increase up to 100 mg/day in order to achieve low HbA1c level less than 7.4%. We compared biomarkers concerning glucose and lipoprotein metabolism before and after the administration of sitagliptin for twelve weeks. There were significant decreases in fasting glucose levels and HbA1c levels as well as fasting TG levels and non HDL-C levels. Biomarkers of remnant lipoproteins, fasting apolipoprotein(apo) B-48 and RemL-C levels were significantly decreased by sitagliptin. Moreover, there were significant decreases in other apolipoproteins such as apoB, apoC2, C3 and apoE. Cholesterol and TG concentrations of lipoprotein fractions in the size of VLDL and LDL were significantly decreased by sitagliptin assessed by the high performance liquid chromatography(HPLC) analysis. These findings indicated that the administration of sitagliptin improved the lipid and lipoprotein profile in patients with type II diabetes mellitus, which might be due to the decrease in atherogenic remnant lipoproteins.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Patients with type 1 diabetes 2. Patients with severe renal disorder (including hemodialysis) with a serum creatinine (Cr) level (mg/dL) >2.5 for males and >2.0 for females 3. Patients who have already received a sulfonylurea drug at a higher dose than the following dose: (Amaryl: 2 mg, Euglucon: 1.25 mg, and Glimicron: 40 mg), when it is clinically judged that the dose of the sulfonylurea cannot be decreased when sitagliptin is added. The criteria for a decrease in the dose of the sulfonylurea when sitagliptin is added are as follows: For patients who receive glimepiride (Amaryl) at a dose of >2 mg/day, the dose should be decreased to <2 mg/day. For patients who receive glibenclamide (Euglucon and Daonil) at a dose of >1.25 mg/day, the dose should be decreased to <1.25 mg/day. For patients who receive gliclazide (Glimicron) at a dose of >40 mg/day, the dose should be decreased to <40 mg/day. 4. Patients who have already taken Sitagliptin, Alogliptin, or Vildagliptin. 5. Patients who newly started taking a statin, fibrate, ezetimibe, or probucol within 1 month of the start of the study 6. Patients who are pregnant or may become pregnant 7. Patients receiving treatment for thyroid failure 8. Patients with severe hepatic dysfunction with AST and ALT >100 IU/L 9. Patients who have participated in another clinical study 10. Other patients who judged not to be eligible to participate in the study by their primary physician