Effect of Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number Type 2 Diabetes

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of Dipeptidyl peptidase (DPP) -IV inhibitor Vildagliptin vs. Glibenclamide on circulating endothelial progenitor cells (EPCs) number in type 2 diabetes patients in metformin failure. Subjects will be followed for 12 months after randomization.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma
• Treatments: Glyburide; Metformin; Vildagliptin

Criteria

Inclusion Criteria:

• Age equal or above 35 years;

• Diagnosis of type 2 diabetes mellitus as defined by the American Diabetes Association , with at least one year of disease duration at the time of the screening visit;

• Blood glucose lowering treatment with Metformin alone (monotherapy) at a stable dose of at least 1.5 g/day (or maximum tolerated dose) in the 3 months prior to the screening visit;

• Insufficient metabolic control as defined by recent (last six months) HbA1c ≥ 7% in any peripheral laboratory and confirmed at the time of the screening;

• Absence of a recent clinically-relevant progression of micro- and macro-vascular complications (see exclusion criteria);

• Written informed consent to participate to the study.

Exclusion criteria:

• Age below 35 years

• Type 1 diabetes or other causes of diabetes (pancreatectomy, gestational diabetes, etc.)

• HbA1c < 7% or ≥ 9% at the screening visit

• Treatment with any blood glucose lowering treatment other than Metformin in the six months before screening visit

• BMI < 20 or ≥ 40 kg/m2, or current/ past history of clinically-relevant eating disorders (including -but no limited to- nervous anorexia, bulimia, binge-eating disorders, etc.)

• Significant progression of diabetic macro-angiopathy or cardiovascular disease in the six months prior to study visit

• Significant progression of diabetic micro-angiopathy in the six months prior to study visit

• Organ failure or other severe diseases limiting life expectancy;

• Beginning, in the three months before screening visit, of any kind of drug which can modify glycemic levels (beta-blockers, diuretics…), or acute disease (acute infection, urinary tract infection…) in three months before screening visit

• History of inflammatory/infective/autoimmune chronic disease

• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, gastric surgery, inflammatory bowel disease;

• Any clinically significant abnormality identified on physical examination, laboratory tests, ECG or vital signs at screening that in the judgment of the investigator would preclude safe completion of the study;

• Uncontrolled or inadequately controlled hypertension at screening (Systolic Blood Pressure (SBP)>190 or Diastolic Blood Pressure (DBP) >100 mmHg)

• Ongoing pregnancy or absence of effective contraception in women with childbearing potential

• Contraindications to the maintenance of the background therapy (Metformin), including -but not limited to- chronic kidney failure or plasma creatinine concentrations > 1.5 mg/dL, severe respiratory failure, etc.;

• Contraindications to the use of a Sulfonylurea;

• Contraindications to the use of a DPP-IV Inhibitor;

• Laboratory findings, or other disease conditions, at the screening visit that might interfere with study measurements:

1. Hemoglobinopathy known to affect HbA1c assays;

2. Known chronic liver diseases, including HBV (hepatitis B virus) and HCV (hepatitis C virus) infection;

3. Liver makers (aspartate transaminase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), Gamma-glutamyltransferase (GGT) , bilirubin) above 2 times the upper normal limit;

4. Amylase and/or lipase above 2 times the upper normal limit;

• Chronic use of systemic and/or inhaled corticosteroids (only topical corticosteroids are allowed);

• History of low compliance, clinically-relevant psychiatric disorders or any current/ historical finding suggesting the patient as inappropriate to follow the study procedures.