Vascular Effects of Sitagliptin in Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Hannover Medical School.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01096277
First received: March 26, 2010
Last updated: March 30, 2010
Last verified: March 2010

March 26, 2010
March 30, 2010
October 2010
November 2011   (final data collection date for primary outcome measure)
Endothelial function [ Time Frame: Before and after two week treatment ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01096277 on ClinicalTrials.gov Archive Site
Effect on EPCs [ Time Frame: Before and after two week treatment ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Vascular Effects of Sitagliptin in Diabetes Mellitus
Metabolism-independent Vascular Effects of the Dipetidylpeptidase-4-inhibitor Sitagliptin in Patients With Type 2 Diabetes Mellitus

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

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Sitagliptin
    oral tablets 100 mg per day for two weeks
    Other Name: Sitagliptin
  • Drug: Placebo
    oral tablet, one per day for two weeks
    Other Name: Placebo
  • Other: Control
    no intervention
    Other Name: Control
  • Active Comparator: Sitagliptin
    100 mg sitagliptin per day for 2 weeks
    Intervention: Drug: Sitagliptin
  • Placebo Comparator: Placebo
    1 placebo tablet per day for 2 weeks
    Intervention: Drug: Placebo
  • No Intervention: Healthy Control
    Healthy control subjects
    Intervention: Other: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
70
December 2012
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 Diabetes mellitus

Exclusion Criteria:

  • Allergy to sitagliptin
  • Treatment with PPAR-gamma agonist
Both
18 Years to 80 Years
Yes
Contact: Sajoscha A. Sorrentino, MD +49511532 ext 2101 sorrentino.sajoscha@mh-hannover.de
Contact: Bernhard M. Schmidt, MD +49511532 ext 8554 schmidt.bernhard@mh-hannover.de
Germany
 
NCT01096277
MHH_NPH_SS_1/2010, MHH_NPH_SS_1/2010
No
Sajoscha A. Sorrentino, MD, Hannover Medical School
Hannover Medical School
Not Provided
Principal Investigator: Sajoscha A. Sorrentino, M.D. Hannover Medical School
Hannover Medical School
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP