valuation of the effect of a new drug for diabetes on atherosclerosis in patients with primary failure metformin

evaluation of the effect of treatment with DPP-4 inhibitor on endothelial function versus sulphonylurea on markers of oxidative stress and inflammation and platelet function in patients with diabetes mellitus type 2 in primary failure with metformin and with HbA1c values ??below 8, 5%

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000152-34-IT

Enrollment

Registered

2012-03-05

Start date

2012-02-09

Completion date

Unknown

Last updated

2012-07-31

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

Conditions

Type 2 diabetes MedDRA version: 14.1 Level: SOC Classification code 10027433 Term: Metabolism and nutrition disorders System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: JANUVIA*28CPR RIV 100MG Pharmaceutical Form: Film-coated tablet INN or Proposed INN: SITAGLIPTIN CAS Number: 790712-60-6 Current Sponsor code: NA Other descriptive name: NA Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: neoplasms, treatment with ASA, nitrates, statins, renal failure, pregnancy, recent surgery

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactDay service I clinica medica

Azienda policlinico umberto I

maria.delben@uniroma1.it+390649972249

Outcome results

None listed

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