valuation of the effect of a new drug for diabetes on atherosclerosis in patients with primary failure metformi
- Conditions
- Type 2 diabetesMedDRA version: 14.1Level: SOCClassification code 10027433Term: Metabolism and nutrition disordersSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2012-000152-34-IT
- Lead Sponsor
- AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
type 2 diabetes non responder to metformin
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 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64
Exclusion Criteria
neoplasms, treatment with ASA, nitrates, statins, renal failure, pregnancy, recent surgery
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: evaluate the role of DPP4 inhibitors on endothelial function and oxidative stress;Secondary Objective: evaluate the role of DPP 4 inhibitors on lipid and glycemic control;Primary end point(s): evaluate the role of DPP4 inhibitors on endothelial function and oxidative stress;Timepoint(s) of evaluation of this end point: month 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): evaluate the role of DPP 4 inhibitors on lipid and glycemic control;Timepoint(s) of evaluation of this end point: month 12