Status:
UNKNOWN
Thiazolidinediones Or Sulphonylureas and Cardiovascular Accidents.Intervention Trial
Lead Sponsor:
Italian Society of Diabetology
Collaborating Sponsors:
Associazione Medici Diabetologi (AMD)
Associazione Nazionale Medici Cardiologi Ospedalieri
Conditions:
Type 2 Diabetes Mellitus
Cardiovascular Disease
Eligibility:
All Genders
50-75 years
Phase:
PHASE4
Brief Summary
Background: In patients with type 2 diabetes inadequately controlled with metformin, two main therapeutic options are equally plausible: add-on a sulfonylurea (SU) or a thiazolidinedione (TZD). Since ...
Detailed Description
Cardiovascular (CV) disease is the most common cause of morbidity and mortality among diabetic patients.The UK Prospective Diabetes Study (UKPDS)clearly showed that tight glycemic control significantl...
Eligibility Criteria
Inclusion
- Males and females, age 50-75 years
- Type 2 diabetes of at least 2 years duration
- BMI 20-45 Kg/m2
- Stable treatment for the last two months with metformin in monotherapy (at least 2 gr/die)
- HbA1c \>=7.0% and \<=9.0%
Exclusion
- Type 1 diabetes
- Previous treatment with thiazolidinediones in the last six months
- Contraindication/intolerance to metformin or SUs or TZDs
- Documented coronary or cerebrovascular events in the previous 3 months
- Serum creatinine \> 1.5 mg/dl
- History of congestive heart failure, NYHA I or higher
- Chronic use of glucocorticoids
- Ischemic ulcer or gangrene
- Liver cirrhosis or severe hepatic dysfunction (ALT increase of 2.5 times the upper normal limit)
- Pregnancy or breast feeding
- Cancer, substance abuse, or any health problem that may interfere with the compliance to the study protocol or limit life expectancy
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
3371 Patients enrolled
Trial Details
Trial ID
NCT00700856
Start Date
September 1 2008
End Date
December 1 2018
Last Update
August 27 2015
Active Locations (61)
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1
Ospedale Locatelli di Piario
Seriate, Bergamo, Italy
2
Hospitaal of Treviglio
Treviglio, Bergamo, Italy
3
Hospital of Lanciano
Lanciano, Chieti, Italy
4
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy