Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy

IKFE Institut für klinische Forschung und Entwicklung

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus Type II

Treatments: Drug: Metformin; Drug: Vildagliptin; Drug: Glimepiride

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01565096

ikfe-Vilda-001

2011-004286-32 (EudraCT Number)

CLAF237ADE06T (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Vildagliptin plus Metformin

Experimental group

Description:

Metformin (1000 mg BID) + Vildagliptin 50 mg twice daily

Treatment:

Drug: Metformin

Drug: Metformin

Drug: Vildagliptin

Glimepirid plus Metformin

Active Comparator group

Description:

Metformin (1000 mg BID) + Glimepiride (individual dosage)

Treatment:

Drug: Glimepiride

Drug: Metformin

Drug: Metformin