- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01096277
Vascular Effects of Sitagliptin in Diabetes Mellitus
Metabolism-independent Vascular Effects of the Dipetidylpeptidase-4-inhibitor Sitagliptin in Patients With Type 2 Diabetes Mellitus
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Sajoscha A. Sorrentino, MD
- Phone Number: 2101 +49511532
- Email: sorrentino.sajoscha@mh-hannover.de
Study Contact Backup
- Name: Bernhard M. Schmidt, MD
- Phone Number: 8554 +49511532
- Email: schmidt.bernhard@mh-hannover.de
Study Locations
-
-
-
Hannover, Germany, 30625
- Hannover Medical School
-
Contact:
- Sajoscha A. Sorrentino, MD
- Email: sorrentino.sajoscha@mh-hannover.de
-
Principal Investigator:
- Sajoscha A. Sorrentino, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type 2 Diabetes mellitus
Exclusion Criteria:
- Allergy to sitagliptin
- Treatment with PPAR-gamma agonist
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sitagliptin
100 mg sitagliptin per day for 2 weeks
|
oral tablets 100 mg per day for two weeks
|
Placebo Comparator: Placebo
1 placebo tablet per day for 2 weeks
|
oral tablet, one per day for two weeks
|
No Intervention: Healthy Control
Healthy control subjects
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endothelial function
Time Frame: Before and after two week treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect on EPCs
Time Frame: Before and after two week treatment
|
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
|
Before and after two week treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sajoscha A. Sorrentino, M.D., Hannover Medical School
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Sitagliptin Phosphate
Other Study ID Numbers
- MHH_NPH_SS_1/2010 (Other Identifier: Hannover Medical School)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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