Status:
COMPLETED
Vildagliptin and Endothelium-dependent Vasodilatation
Lead Sponsor:
Radboud University Medical Center
Conditions:
Type 2 Diabetes
Endothelial Dysfunction
Eligibility:
All Genders
35-75 years
Phase:
PHASE3
Brief Summary
Rationale: Cardiovascular complications in type 2 diabetes are the leading cause of morbidity and mortality associated with the disease. Endothelial dysfunction is regarded as an important factor in t...
Eligibility Criteria
Inclusion
- Type 2 diabetes
- Age 35-75 years
- Treatment with metformin monotherapy or metformin combination therapy
- HbA1c \<8.0%
Exclusion
- Renal disease defined as creatinine level \> 130 umol/l
- Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
- Current use of acetylsalicylic acid or vitamine K antagonists
- History of smoking within the past year
- History of or current abuse of drugs or alcohol
- History of heartfailure (NYHA class III or IV)
- Abnormalities on ECG that might interfere with current study protocol
- Pregnancy or breastfeeding
- Inability to understand the nature and extent of the trial and procedures required
- Presence of any medical condition that might interfere with the current study protocol
- Participation in a drug trial within 60 days prior to the first dose
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01000688
Start Date
January 1 2010
End Date
October 1 2010
Last Update
November 5 2010
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB