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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by ikfe-CRO GmbH.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Novartis Pharmaceuticals
IKFE Institute for Clinical Research and Development
Information provided by (Responsible Party):
ikfe-CRO GmbH
ClinicalTrials.gov Identifier:
NCT01565096
First received: March 23, 2012
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Diabetes Mellitus Type II
Drug: Metformin
Drug: Vildagliptin
Drug: Glimepiride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ikfe-CRO GmbH:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Fasting intact proinsulin levels [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Max postprandial intact proinsulin levels [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Retinal endothelial response to flicker light stimulation [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Mean 24h systolic and diastolic blood pressure [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Erythrocyte deformability [ Time Frame: One year ] [ Designated as safety issue: No ]
  • E-selectin [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: One year ] [ Designated as safety issue: No ]
  • hsCRP [ Time Frame: One year ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Fasting blood glucose [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Number of hypoglycemic events [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Drug related adverse events [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 44
Study Start Date: November 2011
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01565096

Contacts
Contact: Thomas Forst, Prof. Dr. +49 6131 576 36 16 thomasf@ikfe.de
Contact: Swantje Anders +49 6131 327 90 22 s.anders@ikfe-cro.de

Locations
Germany
ikfe GmbH Recruiting
Mainz, Germany, 55116
Contact: Thomas Forst, Prof., MD    +49 6131 576 36 16    thomasf@ikfe.de   
Contact: Swantje Anders    +49 6131 327 90 22    s.anders@ikfe-cro.de   
Sponsors and Collaborators
ikfe-CRO GmbH
Novartis Pharmaceuticals
IKFE Institute for Clinical Research and Development
Investigators
Principal Investigator: Thomas Forst, Prof. Dr. Ikfe GmbH
  More Information

No publications provided

Responsible Party: ikfe-CRO GmbH
ClinicalTrials.gov Identifier: NCT01565096     History of Changes
Other Study ID Numbers: ikfe-Vilda-001, 2011-004286-32, CLAF237ADE06T
Study First Received: March 23, 2012
Last Updated: March 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Vildagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014