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

NCT ID: NCT01565096

Last Updated: 2012-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30

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.

Conditions

Diabetes Mellitus Type II

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vildagliptin plus Metformin

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

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin 1000 mg BID

Vildagliptin

Intervention Type: DRUG

Vildagliptin 50 mg twice daily

Glimepirid plus Metformin

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

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Metformin 1000 mg BID

Glimepiride

Intervention Type: DRUG

Glimepiride at individual dose

Interventions

Metformin

Metformin 1000 mg BID

Intervention Type: DRUG

Metformin

Metformin 1000 mg BID

Intervention Type: DRUG

Vildagliptin

Vildagliptin 50 mg twice daily

Intervention Type: DRUG

Glimepiride

Glimepiride at individual dose

Intervention Type: DRUG

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

IKFE Institute for Clinical Research and Development

OTHER

Sponsor Role: collaborator

ikfe-CRO GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Forst, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Ikfe GmbH

Locations

ikfe GmbH

Mainz, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Thomas Forst, Prof. Dr.

Role: CONTACT

thomasf@ikfe.de

+49 6131 576 36 16

Swantje Anders

Role: CONTACT

s.anders@ikfe-cro.de

+49 6131 327 90 22

Facility Contacts

Thomas Forst, Prof., MD

Role: primary

thomasf@ikfe.de

+49 6131 576 36 16

Swantje Anders

Role: backup

s.anders@ikfe-cro.de

+49 6131 327 90 22

Other Identifiers

2011-004286-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLAF237ADE06T

Identifier Type: OTHER

Identifier Source: secondary_id

ikfe-Vilda-001

Identifier Type: -

Identifier Source: org_study_id