Vascular Effects of Sitagliptin in Diabetes Mellitus
Metabolism-independent Vascular Effects of the Dipetidylpeptidase-4-inhibitor Sitagliptin in Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
70
1 country
1
Brief Summary
Glucagon-like peptide 1 (GLP-1) is a 30-amino acid gut hormone secreted in a nutrient-dependent manner that stimulates insulin secretion and inhibits glucagon secretion and gastric emptying, thereby reducing postprandial glycemia.1,2 GLP-1 is derived from posttranslational proteolysis of preproglucagon, and its peptide sequence is identical in mouse, rat, and human.2,3 After secretion from enteroendocrine L cells, GLP-1(7-36) amide is rapidly degraded by dipeptidyl peptidase-4 (DPP-4) to its N-terminally truncated metabolite GLP-1(9-36), which does not interact with the known GLP-1 receptor.4,5 The diverse actions of GLP-1 include the proliferation, differentiation, and protection from apoptosis of pancreatic β cells and the induction of satiety. GLP-1 also improves memory and learning, stimulates afferent sensory nerves, and has neuroprotective functions.1,6 Furthermore, GLP-1 receptor agonists have been reported to have cardiac and vascular actions in rodents and humans that include effects on contractility, blood pressure, cardiac output,7-10 and cardioprotection.11-14
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 type-2-diabetes-mellitus
Started Oct 2010
Typical duration for phase_4 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2010
CompletedFirst Posted
Study publicly available on registry
March 31, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMarch 31, 2010
March 1, 2010
1.1 years
March 26, 2010
March 30, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Endothelial function
Effect of sitagliptin on endothelium-dependent vasodilation before and after treatment of patients with type 2 diabetes mellitus with the DPP-4-inhibitor sitagliptin and placebo treatment respectively
Before and after two week treatment
Secondary Outcomes (1)
Effect on EPCs
Before and after two week treatment
Study Arms (3)
Sitagliptin
ACTIVE COMPARATOR100 mg sitagliptin per day for 2 weeks
Placebo
PLACEBO COMPARATOR1 placebo tablet per day for 2 weeks
Healthy Control
NO INTERVENTIONHealthy control subjects
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes mellitus
You may not qualify if:
- Allergy to sitagliptin
- Treatment with PPAR-gamma agonist
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hannover Medical School
Hanover, 30625, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sajoscha A. Sorrentino, M.D.
Hannover Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 26, 2010
First Posted
March 31, 2010
Study Start
October 1, 2010
Primary Completion
November 1, 2011
Study Completion
December 1, 2012
Last Updated
March 31, 2010
Record last verified: 2010-03