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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

Primary Purpose

Diabetes Mellitus Type II

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Metformin
Metformin
Vildagliptin
Glimepiride
Sponsored by
ikfe-CRO GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type II

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ikfe GmbHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vildagliptin plus Metformin

Glimepirid plus Metformin

Arm Description

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

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

Outcomes

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)

Secondary Outcome Measures

Fasting intact proinsulin levels
Max postprandial intact proinsulin levels
Retinal endothelial response to flicker light stimulation
Mean 24h systolic and diastolic blood pressure
Erythrocyte deformability
E-selectin
Change in body weight
hsCRP
HbA1c
Fasting blood glucose
Number of hypoglycemic events
Adverse events
Drug related adverse events

Full Information

First Posted
March 23, 2012
Last Updated
March 26, 2012
Sponsor
ikfe-CRO GmbH
Collaborators
Novartis Pharmaceuticals, IKFE Institute for Clinical Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01565096
Brief Title
Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy
Official Title
Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ikfe-CRO GmbH
Collaborators
Novartis Pharmaceuticals, IKFE Institute for Clinical Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vildagliptin plus Metformin
Arm Type
Experimental
Arm Description
Metformin (1000 mg BID) + Vildagliptin 50 mg twice daily
Arm Title
Glimepirid plus Metformin
Arm Type
Active Comparator
Arm Description
Metformin (1000 mg BID) + Glimepiride (individual dosage)
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin 1000 mg BID
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin 1000 mg BID
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Intervention Description
Vildagliptin 50 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Glimepiride
Intervention Description
Glimepiride at individual dose
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Fasting intact proinsulin levels
Time Frame
One year
Title
Max postprandial intact proinsulin levels
Time Frame
One year
Title
Retinal endothelial response to flicker light stimulation
Time Frame
One year
Title
Mean 24h systolic and diastolic blood pressure
Time Frame
One year
Title
Erythrocyte deformability
Time Frame
One year
Title
E-selectin
Time Frame
One year
Title
Change in body weight
Time Frame
One year
Title
hsCRP
Time Frame
One year
Title
HbA1c
Time Frame
One year
Title
Fasting blood glucose
Time Frame
One year
Title
Number of hypoglycemic events
Time Frame
One year
Title
Adverse events
Time Frame
One year
Title
Drug related adverse events
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Forst, Prof. Dr.
Phone
+49 6131 576 36 16
Email
thomasf@ikfe.de
First Name & Middle Initial & Last Name or Official Title & Degree
Swantje Anders
Phone
+49 6131 327 90 22
Email
s.anders@ikfe-cro.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Forst, Prof. Dr.
Organizational Affiliation
Ikfe GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
ikfe GmbH
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Forst, Prof., MD
Phone
+49 6131 576 36 16
Email
thomasf@ikfe.de
First Name & Middle Initial & Last Name & Degree
Swantje Anders
Phone
+49 6131 327 90 22
Email
s.anders@ikfe-cro.de

12. IPD Sharing Statement

Learn more about this trial

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

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