The effect of sitagliptin on postprandial lipoprotein metabolism in patients with diabetes mellitus type 2

Med. Klinik II, Grosshadern, Klinikum der Universität München0 个研究点开始时间: 2009年9月23日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Subject (male or female) 19-70 years
•Subject has type 2 diabetes mellitus
•Subject did not receive any glucose lowering drug therapy for 6 weeks (at least 12 weeks if previous medication was rosiglitazone or pioglitazone).
•Dosage of any concomitant medication has been stable for at least 3 weeks
•HbA1c level is 6.5%-8%
•If female, postmenopausal for the past 12 months, surgically sterile or using an adequate method of birth control or sterilized partner
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Subjects with additional causes for hyperglycemia
•Lipid lowering drug therapy
•Clinical condition requiring, lipid lowering drug therapy
•Subject has history of cardiovascular ischemia in previous 3 months or acute myocardial infarction or unstable angina
•Subject has a history of psychiatric disorder or cognitive impairment that would interfere with participation in the study
•Subject has a history of alcoholism
•Subject is taking regular daily narcotics
•Subject has a contraindication against glimepiride or sitagliptin
•Subject has participated in an investigational study within 30 days prior to study initiation
•Subject is pregnant or breast feeding
•patients with life-threatening disease (e.g. cancer)
•patients with renal insufficiency (Creatinine-Clearance < 50 ml/min)
•patients with major hepatic impairment
•known allergic reactions/ intolerance against Sitagliptin or glimepride

发起方

Med. Klinik II, Grosshadern, Klinikum der Universität München