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Clinical Trials/EUCTR2009-016053-18-NL
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.

Registry
who.int
Start Date
October 15, 2009
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
MC St Radboud

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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