Effect of adding Vildagliptin on beta cell function and the cardiovascular risk 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004286-32-DE

Enrollment

Registered

2011-10-06

Start date

2011-11-09

Completion date

Unknown

Last updated

2012-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus Type 2 MedDRA version: 14.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Eucreas Product Name: Eucreas Pharmaceutical Form: Coated tablet INN or Proposed INN: Vildagliptin CAS Number: 274901-16-5 Current Sponsor code: Vildagliptin Other descriptive name: (2S)-{

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diabetes mellitus type 2 2. HbA1c > 6.5 % * = 9.5% * NOTE: Patients with cardiovascular preconditions (Coronary Heart Disease or Myocard Infarction) require an HbA1c > 7.0% = 9.5% 3. Treatment with Metformin at maximal or maximal tolerated dosage, stable for at least 3 months with indication of treatment with an additional medication as judged by investigator 4. Age 30 – 80 years 5. Patient consents that his/her family physician will be informed of trial participation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 44

Exclusion criteria

Exclusion criteria: 1. Pre-treatment with insulin, PPAR gamma agonists or other oral antidiabetic treatments (except Metformin) within the last three months 2. History of type-1-diabetes 3. Fasting blood glucose >240mg/dl 4. Uncontrolled hypertension (systolic blood pressure >160 and/or diastolic blood pressure >90) 5. Anamnestic history of acute infections 6. Anamnestic history of epilepsy 7. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures 8. History of severe or multiple allergies 9. Hereditary galactose intolerance, lapp-lactase defect or glucose-galactose mal-absorption 10. Treatment with any other investigational drug within 3 months before trial entry 11. Pregnant or lactating women 12. 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 IUDs, sexual abstinence or vasectomized partner 13. Progressive fatal disease 14. History of drug or alcohol abuse in the past 2 years 15. State after kidney transplantation 16. Serum potassium > 5.5 mmol/L 17. Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous 6 months 18. Any elective surgery during study participation 19. 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 20. History of pancreatitis 21. Anamnestic history of dehydration, precoma diabeticum or diabetic ketoacidosis 22. Acute or scheduled investigation with iodine containing radiopaque material 23. Uncontrolled unstable angina pectoris 24. Anamnestic history of pericarditis, myocarditis, endocarditis, hemodynamic relevant aortic stenosis, aortic aneurysm or heart insufficiency NYHA III or IV 25. Anamnestic recent pulmonary embolism 26. 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 27. Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to assess the effect of additional Vildagliptin on beta cell function and cardiovascular risk compared to therapy with Metformin and Glimepiride in T2DM patients previously on Metformin monotherapy by means of postprandial intact proinsulin levels.;Secondary Objective: 1. To assess the effect of Metformin and Vildagliptin compared to Metformin and Glimepiride (1-4 mg) on beta cell function 2. To assess the effect of Metformin and Vildagliptin compared to Metformin and Glimepiride (1-4 mg) on blood glucose control and hypoglycemic events 3. To assess the effect of Metformin and Vildagliptin compared to Metformin and Glimepiride (1-4 mg) on body weight 4. To assess the effect of Metformin and Vildagliptin compared to Metformin and Glimepiride (1-4 mg) on blood pressure 5. To assess the effect of Metformin and Vildagliptin compared to Metformin and Glimepiride (1-4 mg) on endothelial function and cardiovascular risk markers 6. To assess the effect of Metformin and Vildagliptin compared to Metformin and Glimepiride (1-4 mg) on inflammation markers 7. To evaluate the collected safety parameters ;Primary end point(s): 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).;Timepoint(s) of evaluation of this end point: End of study (after approx. 12 month)	—

Measure

Time frame

Main Objective: The main objective is to assess the effect of additional Vildagliptin on beta cell function and cardiovascular risk compared to therapy with Metformin and Glimepiride in T2DM patients previously on Metformin monotherapy by means of postprandial intact proinsulin levels.;Secondary Objective: 1. To assess the effect of Metformin and Vildagliptin compared to Metformin and Glimepiride (1-4 mg) on beta cell function 2. To assess the effect of Metformin and Vildagliptin compared to Metformin and Glimepiride (1-4 mg) on blood glucose control and hypoglycemic events 3. To assess the effect of Metformin and Vildagliptin compared to Metformin and Glimepiride (1-4 mg) on body weight 4. To assess the effect of Metformin and Vildagliptin compared to Metformin and Glimepiride (1-4 mg) on blood pressure 5. To assess the effect of Metformin and Vildagliptin compared to Metformin and Glimepiride (1-4 mg) on endothelial function and cardiovascular risk markers 6. To assess the effect of Metformin and Vildagliptin compared to Metformin and Glimepiride (1-4 mg) on inflammation markers 7. To evaluate the collected safety parameters ;Primary end point(s): 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).;Timepoint(s) of evaluation of this end point: End of study (after approx. 12 month)

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Fasting intact proinsulin levels 2. Max postprandial intact proinsulin levels 3. Blood glucose control (HbA1c, fasting blood Glucose, number of hypoglycemic events) 4. Analysis of the following markers for endothelial function and cardiovascular risk: • retinal endothelial response to flicker light stimulation • retinal arterial wall to lumen ratio (WLR) • mean 24h systolic and diastolic blood pressure • mean daily 12 hour systolic and diastolic blood pressure • mean nocturnal 12 hour systolic and diastolic blood pressure • erythrocyte deformability • blood lipids • Adiponectin • BNP • PAI-1 • ADMA • cGMP 5. Analysis of markers for subclinical inflammations: • E-selectin • hs-CRP 6. Change in body weight ;Timepoint(s) of evaluation of this end point: End of study (after approx. 12 month)	—

Measure

Time frame

Secondary end point(s): 1. Fasting intact proinsulin levels 2. Max postprandial intact proinsulin levels 3. Blood glucose control (HbA1c, fasting blood Glucose, number of hypoglycemic events) 4. Analysis of the following markers for endothelial function and cardiovascular risk: • retinal endothelial response to flicker light stimulation • retinal arterial wall to lumen ratio (WLR) • mean 24h systolic and diastolic blood pressure • mean daily 12 hour systolic and diastolic blood pressure • mean nocturnal 12 hour systolic and diastolic blood pressure • erythrocyte deformability • blood lipids • Adiponectin • BNP • PAI-1 • ADMA • cGMP 5. Analysis of markers for subclinical inflammations: • E-selectin • hs-CRP 6. Change in body weight ;Timepoint(s) of evaluation of this end point: End of study (after approx. 12 month)

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Countries

Germany

Contacts

Public ContactCRO

ikfe CRO GmbH

s.anders@ikfe-cro.de004961313279022

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026