Diabetes mellitus type 2 MedDRA version: 9.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent MedDRA version: 9.1 Level: LLT Classification code 10012619 Term: Diabetes mellitus poor control MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control
Conditions
Interventions
Trade Name: Januvia 100 mg Filmtabletten
Product Name: Januvia 100 mg Filmtabletten
Pharmaceutical Form: Capsule, hard
CAS Number: 654671-78-0
Other descriptive name: SITAGLIPTIN PHOSPHATE
Concentrat
Sponsors
Med. Klinik II, Grosshadern, Klinikum der Universität München
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed