EUCTR2009-016053-18-NL
Active, not recruiting
Phase 1
The effect of vildagliptin on endothelium-dependent vasodilatation. A double blind, cross-over study in type 2 diabetes. - Vildagliptin and vasodilatation
MC St Radboud0 sites16 target enrollmentOctober 15, 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- The effect of vildagliptin on endothelial dysfunction in type 2 diabetes, assessed by measuring endothelium-dependent vasodilatation
- Sponsor
- MC St Radboud
- Enrollment
- 16
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The research population will consist of patients with type 2 diabetes of all ethnic backgrounds, both sexes and age 35\-75 years.
- •Inclusion criteria
- •Type 2 diabetes
- •Age 35\-75 years
- •Treatment with metformin monotherapy or metformin combination therapy
- •HbA1c \<8\.0 %
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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