Clinical trial NCT01565096: Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy
Official title: Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus Type II
Lead sponsor: ikfe-CRO GmbH
Sponsor class: INDUSTRY
Collaborators: name: Novartis Pharmaceuticals
name: IKFE Institute for Clinical Research and Development
First posted: 2012-03-28
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Postprandial increase in intact proinsulin levels in patient treated with Vildagliptin and Metformin compared to intact proinsulin levels in patients treated with Glimepiride and Metformin (Area under the curve 0-300 min)
timeFrame: One year
Secondary outcomes:
measure: Fasting intact proinsulin levels
timeFrame: One year
measure: Max postprandial intact proinsulin levels
timeFrame: One year
measure: Retinal endothelial response to flicker light stimulation
timeFrame: One year
measure: Mean 24h systolic and diastolic blood pressure
timeFrame: One year
measure: Erythrocyte deformability
timeFrame: One year
measure: E-selectin
timeFrame: One year
measure: Change in body weight
timeFrame: One year
measure: hsCRP
timeFrame: One year
measure: HbA1c
timeFrame: One year
measure: Fasting blood glucose
timeFrame: One year
measure: Number of hypoglycemic events
timeFrame: One year
measure: Adverse events
timeFrame: One year
measure: Drug related adverse events
timeFrame: One year
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: ikfe GmbH
Study officials:
affiliation: Ikfe GmbH
name: Thomas Forst, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: