Type 2 diabetes MedDRA version: 20.0 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 100000004861
Conditions
Interventions
Trade Name: CARDIOASPIRIN - 100 MG COMPRESSE GASTRORESISTENTI30 COMPRESSE
Product Name: Cardioaspirin
Product Code: [NA]
Pharmaceutical Form: Tablet
INN or Proposed INN: ACIDO ACETILSALICILICO
Current
Sponsors
UMBERTO I - POLICLINICO DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age =35 years - Diagnosis of type 2 diabetes: - random blood glucose = 200 mg / dl (=11.1 mmol/l) - fasting blood glucose = 126 mg/dl (=7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 h.* - blood glucose 2 hours after oral glucose tolerance test (75 g OGTT) =200 mg/dl. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.* - hemoglobin A1c = 6.5% (= 48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay.* - treatment with any glucose-lowering agent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 209 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 209
Exclusion criteria
Exclusion criteria: 1) History of cardiovascular or cerebrovascular events (defined on history and/or instrumental findings provided by the patient); 2) Presence of inadequate glycemic control (i.e., hemoglobin A1c =8%) 3) Presence of uncontrolled blood pressure despite anti-hypertensive treatment (=140/=85 mmHg) 4) Previous major bleeding (i.e. intracranial) 5) Previous gastro-intestinal ulcer 6) Clinical diagnosis of type 1 diabetes (diagnosis of diabetes and insulin use before 35 years of age); 7) Patients with chronic kidney disease G4 or G5 stage (i.e., eGFR <30 ml/min/1.73 m2 or dialysis); 8) Chronic active infections or 9) Evidence of malignancy in the last 5 years. Patients with in situ neoplastic disease successful treated only with local excision can be included in the study (including in situ non-melanoma skin cancer). 10) Autoimmune systemic diseases; 11) Sustained cardiac arrhythmias requiring anticoagulant treatment (i.e. atrial fibrillation). In this category isolated ventricular/supraventricular extra-systoles are not included; 12) Use of non-steroidal anti-inflammatory drugs, or other antiplatelet agents in the previous 30 days; 13) Cirrhosis of any etiology 14) Use of anticoagulants; 15) Life expectancy <1 year; 16) Known allergy to aspirin; 17) Known pregnancy; 18) Severe psychiatric illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the relationship between progression of renal failure and aspirin use in patients suffering from type 2 diabetes;Secondary Objective: To evaluate the relationship between urinary excretion of thromboxane B2 and changes in renal function;Primary end point(s): The aim of our study is to evaluate the decline of renal function in diabetic patients treated with aspirin 100 mg/day vs. placebo. In particular, we will evaluate: - The absolute change in eGFR, calculated as the difference between eGFR at 12 months - baseline eGFR; - The rapid decline in renal function, defined as a reduction of eGFR =5 ml/min at 1 years. - The change of renal function class (from G1 to G2, from G2 to G3a and so on) at 6 and 12 months.;Timepoint(s) of evaluation of this end point: 6 months and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): As secondary endpoint, we will evaluate changes in the urinary excretion TxB2 both baseline and at one year. Changing levels of urinary TxB2 will then be related to renal function.;Timepoint(s) of evaluation of this end point: 6 months and 1 year | — |
Countries
Italy
Contacts
Public ContactI Clinica Medica
Dipartimento di Medicina Interna e Specialità Mediche - Sapienza Università di Roma
Outcome results
None listed