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

Diabetes Mellitus Type II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01565096
• Other study ID #: ikfe-Vilda-001
• Secondary ID: 2011-004286-32CL
• Status: Recruiting
• Phase: Phase 4
• First received: March 23, 2012
• Last updated: March 26, 2012
• Start date: November 2011

Study information

• Verified date: March 2012
• Source: ikfe-CRO GmbH
• Contact: Thomas Forst, Prof. Dr.
• Phone: +49 6131 576 36 16
• Email: thomasf[@]ikfe.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type II
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Metformin
Metformin 1000 mg BID
• Metformin
Metformin 1000 mg BID
• Vildagliptin
Vildagliptin 50 mg twice daily
• Glimepiride
Glimepiride at individual dose

Locations

Country	Name	City	State
Germany	ikfe GmbH	Mainz

Sponsors (3)

Lead Sponsor	Collaborator
ikfe-CRO GmbH	IKFE Institute for Clinical Research and Development, Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		One year	Yes
Secondary	Fasting intact proinsulin levels		One year	Yes
Secondary	Max postprandial intact proinsulin levels		One year	Yes
Secondary	Retinal endothelial response to flicker light stimulation		One year	No
Secondary	Mean 24h systolic and diastolic blood pressure		One year	Yes
Secondary	Erythrocyte deformability		One year	No
Secondary	E-selectin		One year	No
Secondary	Change in body weight		One year	No
Secondary	hsCRP		One year	No
Secondary	HbA1c		One year	Yes
Secondary	Fasting blood glucose		One year	Yes
Secondary	Number of hypoglycemic events		One year	Yes
Secondary	Adverse events		One year	Yes
Secondary	Drug related adverse events		One year	Yes