effect of adding vildagliptin on beta cell function and cardiovascular risk markers in patients with moderate metabolic control during metformin monotherapy

Conditions: Diabetes Mellitus Type II

Summary: the aim of this pilot-study is to investigate the effect of vildagliptin in comparison to glimepiride on beta cell function and the cardiovascular risk profile in patients previously treated with metformin monotherapy.


Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 * hba1c \> 6.5%\* ≤ 9.5% \* note: patients with cardiovascular preconditions (coronary heart disease or myocard infarction) require an hba1c \> 7.0% ≤ 9.5% * treatment with metformin at maximal or maximal tolerated dosage, stable for at least 3 months with indication for treatment with an additional medication as judged by the investigator * age 30 - 80 years * patient consents that his/her family physician will be informed of trial participation exclusion criteria: * pre-treatment with insulin, peroxisome proliferator activated receptor (ppar) gamma agonists or other oral antidiabetic treatments (except metformin) within the last three months * history of type-1-diabetes * fasting blood glucose \>240mg/dl * uncontrolled hypertension (systolic blood pressure \>160 and/or diastolic blood pressure \>90) * anamnestic history of acute infections * anamnestic history of epilepsy * anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures * history of severe or multiple allergies * hereditary galactose intolerance, lapp-lactase defect or glucose-galactose mal-absorption * treatment with any other investigational drug within 3 months before trial entry * pregnant or lactating women * sexually active woman of childbearing age not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices, sexual abstinence or vasectomized partner * progressive fatal disease * history of drug or alcohol abuse in the past 2 years * state after kidney transplantation * serum potassium \> 5.5 mmol/l * acute myocardial infarction, open heart surgery or cerebral event (stroke/transient ischemic attack) within the previous 6 months * any elective surgery during study participation * have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit * history of pancreatitis * anamnestic history of dehydration, diabetic precoma or diabetic ketoacidosis * acute or scheduled investigation with iodine containing radiopaque material * uncontrolled unstable angina pectoris * anamnestic history of pericarditis, myocarditis, endocarditis, hemodynamic relevant aortic stenosis, aortic aneurysm or heart insufficiency nyha iii or iv * anamnestic recent pulmonary embolism * history of significant cardiovascular, respiratory, gastrointestinal, hepatic (alat and/or asat \> 3 times the normal reference range), renal (gfr \< 60 ml), neurological, psychiatric and/or hematological disease as judged by the investigator * lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study