Vascular Effects of Sitagliptin in Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Sitagliptin
Placebo
Control
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Type 2 Diabetes mellitus
Exclusion Criteria:
- Allergy to sitagliptin
- Treatment with PPAR-gamma agonist
Sites / Locations
- Hannover Medical School
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Arm Label
Sitagliptin
Placebo
Healthy Control
Arm Description
100 mg sitagliptin per day for 2 weeks
1 placebo tablet per day for 2 weeks
Healthy control subjects
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Effect on EPCs
Effect of sitagliptin on mobilization, NO-production and in vivo regenerative capacity of human endothelial progenitor cells before and after treatment of patients with type 2 diabetes mellitus with the DPP-4-inhibitor sitagliptin and placebo treatment respectively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01096277
Brief Title
Vascular Effects of Sitagliptin in Diabetes Mellitus
Official Title
Metabolism-independent Vascular Effects of the Dipetidylpeptidase-4-inhibitor Sitagliptin in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hannover Medical School
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
The aim of this study is to evaluate the effect of a therapy with the DPP-4-inhibitor sitagliptin on the prognostic relevant endothelial function and endothelial progenitor cells in patients with type 2 diabetes mellitus.
Primary endpoint: Endothelium-dependent vasodilation before and after treatment of patients with type 2 diabetes mellitus with the DPP-4-inhibitor Sitagliptin and placebo treatment respectively.
Secondary endpoint: effect of sitagliptin on mobilization, NO-production and in vivo regenerative capacity of human endothelial progenitor cells before and after treatment of patients with type 2 diabetes mellitus with the DPP-4-inhibitor sitagliptin and placebo treatment respectively
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sitagliptin
Arm Type
Active Comparator
Arm Description
100 mg sitagliptin per day for 2 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 placebo tablet per day for 2 weeks
Arm Title
Healthy Control
Arm Type
No Intervention
Arm Description
Healthy control subjects
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Description
oral tablets 100 mg per day for two weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral tablet, one per day for two weeks
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
no intervention
Primary Outcome Measure Information:
Title
Endothelial function
Description
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
Time Frame
Before and after two week treatment
Secondary Outcome Measure Information:
Title
Effect on EPCs
Description
Effect of sitagliptin on mobilization, NO-production and in vivo regenerative capacity of human endothelial progenitor cells before and after treatment of patients with type 2 diabetes mellitus with the DPP-4-inhibitor sitagliptin and placebo treatment respectively
Time Frame
Before and after two week treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Type 2 Diabetes mellitus
Exclusion Criteria:
Allergy to sitagliptin
Treatment with PPAR-gamma agonist
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sajoscha A. Sorrentino, MD
Phone
+49511532
Ext
2101
Email
sorrentino.sajoscha@mh-hannover.de
First Name & Middle Initial & Last Name or Official Title & Degree
Bernhard M. Schmidt, MD
Phone
+49511532
Ext
8554
Email
schmidt.bernhard@mh-hannover.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sajoscha A. Sorrentino, M.D.
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sajoscha A. Sorrentino, MD
Email
sorrentino.sajoscha@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Sajoscha A. Sorrentino, MD
12. IPD Sharing Statement
Learn more about this trial
Vascular Effects of Sitagliptin in Diabetes Mellitus
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