Status:
UNKNOWN
Multifactorial Intervention in Type 2 Diabetes - Italy
Lead Sponsor:
University of Parma
Collaborating Sponsors:
Italian Society of Diabetology
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
50-70 years
Phase:
PHASE4
Brief Summary
Despite several clinical trials have clearly demonstrated that the correction of a single cardiovascular risk factor in patients with type 2 diabetes decreases the incidence of myocardial infarction a...
Detailed Description
The study is multi-centric, randomized, open label, active treatment controlled, two parallel-group, pragmatical intervention trial with 5 years of follow-up, to assess superiority of an intensive tre...
Eligibility Criteria
Inclusion
- Both genders
- age 50-70 years
- Type two diabetes with at least two-year history of disease and without insulin treatment in the first two years after diagnosis
- Negative medical history for documented previous cardiovascular events or macrovascular complications
- Written consent to participate
- Presence of at least 2 of the following risk factors:
- LDL cholesterol \> 130 mg/dL (regardless of treatment)
- Triglycerides \> 200 mg/dL
- HDL cholesterol \< 35 (males) or 45 (females) mg/dL
- Blood pressure \> 140/90 mmHg
- Cigarette smoking
Exclusion
- Age below 50 or above 70 years
- Type 1 diabetes, diagnosis before 40 years of age, known presence of auto-antibodies or insulin requirement in the first 2 years of disease.
- Chronic kidney failure (plasma creatinine \> 2 mg/dL)
- Significant liver damage (AST and/or ALT \> 2 times the upper limits of normality)
- History of previous cardiovascular events
- Active neoplasms or any concomitant disease limiting life expectancy
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
1461 Patients enrolled
Trial Details
Trial ID
NCT01240070
Start Date
January 1 2002
End Date
December 1 2011
Last Update
August 12 2011
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Francesco Giorgino
Bari, Italy
2
Maria Dolci
Carrara, Italy
3
Lamberto De Giorgio
La Spezia, Italy
4
Giuseppe Derosa
Pavia, Italy