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

Conditions: Diabetes mellitus type 2
MedDRA version: 9.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependent
MedDRA version: 9.1Level: LLTClassification code 10012619Term: Diabetes mellitus poor control
MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
MedDRA version: 9.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate control

Registration Number: EUCTR2007-007805-58-DE

Lead Sponsor: Med. Klinik II, Grosshadern, Klinikum der Universität München

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•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

Exclusion Criteria

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the study is to evaluate whether treatment with sitagliptin (100 mg/d) for 10 weeks will result in an improvement of postprandial lipoprotein metabolism compared to glimepiride (1 mg/d) despite similar HbA1c reduction in drug naive type 2 diabetic patients. ;Secondary Objective: Secondary objectives of the trial are to evaluate the effect of sitagliptin on fasting lipids, glucose parameters and inflammatory parameters ;Primary end point(s): incremental area under the triglyceride curve following a standardized oral fat tolerance test

Secondary Outcome Measures