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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01565096
Recruitment Status : Unknown
Verified March 2012 by ikfe-CRO GmbH.
Recruitment status was:  Recruiting
First Posted : March 28, 2012
Last Update Posted : March 28, 2012
Novartis Pharmaceuticals
IKFE Institute for Clinical Research and Development
Information provided by (Responsible Party):
ikfe-CRO GmbH

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type II Drug: Metformin Drug: Vildagliptin Drug: Glimepiride Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy
Study Start Date : November 2011
Estimated Primary Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vildagliptin plus Metformin
Metformin (1000 mg BID) + Vildagliptin 50 mg twice daily
Drug: Metformin
Metformin 1000 mg BID

Drug: Vildagliptin
Vildagliptin 50 mg twice daily

Active Comparator: Glimepirid plus Metformin
Metformin (1000 mg BID) + Glimepiride (individual dosage)
Drug: Metformin
Metformin 1000 mg BID

Drug: Glimepiride
Glimepiride at individual dose

Primary Outcome Measures :
  1. 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) [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Fasting intact proinsulin levels [ Time Frame: One year ]
  2. Max postprandial intact proinsulin levels [ Time Frame: One year ]
  3. Retinal endothelial response to flicker light stimulation [ Time Frame: One year ]
  4. Mean 24h systolic and diastolic blood pressure [ Time Frame: One year ]
  5. Erythrocyte deformability [ Time Frame: One year ]
  6. E-selectin [ Time Frame: One year ]
  7. Change in body weight [ Time Frame: One year ]
  8. hsCRP [ Time Frame: One year ]
  9. HbA1c [ Time Frame: One year ]
  10. Fasting blood glucose [ Time Frame: One year ]
  11. Number of hypoglycemic events [ Time Frame: One year ]
  12. Adverse events [ Time Frame: One year ]
  13. Drug related adverse events [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01565096

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Contact: Thomas Forst, Prof. Dr. +49 6131 576 36 16
Contact: Swantje Anders +49 6131 327 90 22

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ikfe GmbH Recruiting
Mainz, Germany, 55116
Contact: Thomas Forst, Prof., MD    +49 6131 576 36 16   
Contact: Swantje Anders    +49 6131 327 90 22   
Sponsors and Collaborators
ikfe-CRO GmbH
Novartis Pharmaceuticals
IKFE Institute for Clinical Research and Development
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Principal Investigator: Thomas Forst, Prof. Dr. Ikfe GmbH
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Responsible Party: ikfe-CRO GmbH Identifier: NCT01565096    
Other Study ID Numbers: ikfe-Vilda-001
2011-004286-32 ( EudraCT Number )
CLAF237ADE06T ( Other Identifier: Novartis Pharma GmbH )
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action