Intervention trial comparing the effect of DPP-Iv inhibitor Vildagliptin vs. Glibenclamide on circulating EPCs.

Phase 1

• Conditions: type 2 diabetes mellitus; Therapeutic area: Diseases [C] - Hormonal diseases [C19]; MedDRA version: 14.1Level: LLTClassification code 10012614Term: Diabetes mellitus NOSSystem Organ Class: 100000004861

• Registration Number: EUCTR2012-005399-32-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI PARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-11
• Last Update Posted: 4 July 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age equal or above 35 years;
2. 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;
3. 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;
4. Insufficient metabolic control as defined by recent (last six months) HbA1c = 7% in any peripheral laboratory and confirmed at the time of the screening;
5. Absence of a recent clinically-relevant progression of micro- and macro-vascular complications (see exclusion criteria);
6. Written informed consent to participate to the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Age below 35 years
2. Type 1 diabetes or other causes of diabetes (pancreatectomy, gestational diabetes, etc.)
3. HbA1c < 7% or = 9% at the screening visit
4. Treatment with any blood glucose lowering treatment other than Metformin in the six months before screening visit
5. 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.)
6. Significant progression of diabetic macro-angiopathy or cardiovascular disease in the six months prior to study visit, including:
- Acute myocardial infarction or acute coronary syndrome requiring hospitalization;
- Acute cerebro-vascular event requiring hospitalization;
- Acute limb ischemia or new onset of clinically-relevant peripheral artery disease (as defined by claudication + positive ABI test);
- New limb ulceration of suspected vascular origin or new onset of a diabetic foot or significant progression of pre-existing lesions;
- Any revascularization procedure (by-pass, stenting, angioplasty, trombo-endarterectomy, etc.) in any arterial district;
7. Significant progression of diabetic micro-angiopathy in the six months prior to study visit, including:
- Proliferative retinopathy, or progression of severity of more than one step, or new macular edema likely to be laser-treated. Steps of diabetic retinopathy: absent, background, mild non-proliferative, moderate-to-severe non-proliferative, proliferative;
- Increase of at least 0.5 mg/dL of plasma creatinine or progression to macro-proteinuria;
- Onset of clinically-relevant neuropathy
- Onset of erectile dysfunction
8. Organ failure or other severe diseases limiting life expectancy;
9. Beginning, in the three months before screening visit, of any kind of drug which can modify glicemic levels (beta-blockers, diuretics…), or acute disease (acute infection, urinary tract infection…) in three months before screening visit
10. History of inflammatory/infective/autoimmune chronic disease
11. History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, gastric surgery, inflammatory bowel disease;
12. 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;
13. Uncontrolled or inadequately controlled hypertension at screening (SBP>190 or DBP >100 mmHg)
14. Ongoing pregnancy or absence of effective contraception in women with childbearing potential
15. 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.;
16. Contraindications to the use of a Sulfonylurea;
17. Contraindications to the use of a DPP-IV Inhibitor;
18. 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 and HCV infection;
- Liver makers (AST, ALT, ALP, GGT, bilirubin) above 2 times the upper normal limit;
- Amylase and/or lipase above 2 times the upper normal limit;
19. Chronic use of systemic and/or inhaled corticosteroids (only topical corticosteroids are allowed);
20. History of low compliance, clinically-relevant psychiatric disorders or any current/ historical

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified