Status:
COMPLETED
Effect of Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number Type 2 Diabetes
Lead Sponsor:
Azienda Ospedaliero-Universitaria di Parma
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
35+ years
Phase:
PHASE3
Brief 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 diabe...
Detailed Description
Diabetic patients show a higher cardiovascular risk compared with non-diabetic patients. It is therefore crucial that blood glucose lowering drugs reveal a favorable cardiovascular risk profile indepe...
Eligibility Criteria
Inclusion
- 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:
- Hemoglobinopathy known to affect HbA1c assays;
- Known chronic liver diseases, including HBV (hepatitis B virus) and HCV (hepatitis C virus) infection;
- Liver makers (aspartate transaminase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), Gamma-glutamyltransferase (GGT) , bilirubin) above 2 times the upper normal limit;
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01822548
Start Date
October 1 2010
End Date
January 1 2015
Last Update
August 2 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Opedaliera-Universitaria
Parma, Italy, 43126
2
Azienda Ospedaliera-Universitaria
Parma, Italy, 43126