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

March 23, 2012
March 26, 2012
November 2011
November 2012   (final data collection date for primary outcome 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) [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01565096 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy
Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus Type II
  • Drug: Metformin
    Metformin 1000 mg BID
  • Drug: Vildagliptin
    Vildagliptin 50 mg twice daily
  • Drug: Glimepiride
    Glimepiride at individual dose
  • Experimental: Vildagliptin plus Metformin
    Metformin (1000 mg BID) + Vildagliptin 50 mg twice daily
    Interventions:
    • Drug: Metformin
    • Drug: Vildagliptin
  • Active Comparator: Glimepirid plus Metformin
    Metformin (1000 mg BID) + Glimepiride (individual dosage)
    Interventions:
    • Drug: Metformin
    • Drug: Glimepiride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
44
Not Provided
November 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years
No
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
Germany
 
NCT01565096
ikfe-Vilda-001, 2011-004286-32, CLAF237ADE06T
No
ikfe-CRO GmbH
ikfe-CRO GmbH
  • Novartis Pharmaceuticals
  • IKFE Institute for Clinical Research and Development
Principal Investigator: Thomas Forst, Prof. Dr. Ikfe GmbH
ikfe-CRO GmbH
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP