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

Overview[ - collapse ][ - ]

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.
ConditionDiabetes Mellitus Type II
InterventionDrug: Metformin
Drug: Metformin
Drug: Vildagliptin
Drug: Glimepiride
PhasePhase 4
Sponsorikfe-CRO GmbH
Responsible Partyikfe-CRO GmbH
ClinicalTrials.gov IdentifierNCT01565096
First ReceivedMarch 23, 2012
Last UpdatedMarch 26, 2012
Last verifiedMarch 2012

Tracking Information[ + expand ][ + ]

First Received DateMarch 23, 2012
Last Updated DateMarch 26, 2012
Start DateNovember 2011
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresPostprandial 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]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitleEffect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy
Official TitleEffect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionDiabetes Mellitus Type II
InterventionDrug: Metformin
Metformin 1000 mg BID
Drug: Metformin
Metformin 1000 mg BID
Drug: Vildagliptin
Vildagliptin 50 mg twice daily
Drug: Glimepiride
Glimepiride at individual dose
Study Arm (s)
  • Experimental: Vildagliptin plus Metformin
    Metformin (1000 mg BID) + Vildagliptin 50 mg twice daily
  • Active Comparator: Glimepirid plus Metformin
    Metformin (1000 mg BID) + Glimepiride (individual dosage)

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment44
Estimated Completion DateNot Provided
Estimated Primary Completion DateNovember 2012
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
GenderBoth
Ages30 Years
Accepts Healthy VolunteersNo
ContactsContact: Thomas Forst, Prof. Dr.
+49 6131 576 36 16
thomasf@ikfe.de
Location CountriesGermany

Administrative Information[ + expand ][ + ]

NCT Number NCT01565096
Other Study ID Numbersikfe-Vilda-001
Has Data Monitoring CommitteeNo
Information Provided Byikfe-CRO GmbH
Study Sponsorikfe-CRO GmbH
CollaboratorsNovartis Pharmaceuticals
IKFE Institute for Clinical Research and Development
Investigators Principal Investigator: Thomas Forst, Prof. Dr. Ikfe GmbH
Verification DateMarch 2012

Locations[ + expand ][ + ]

ikfe GmbH
Mainz, Germany, 55116
Contact: Thomas Forst, Prof., MD | +49 6131 576 36 16 | thomasf@ikfe.de
Recruiting