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Vascular Effects of Sitagliptin in Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01096277
Recruitment Status : Unknown
Verified March 2010 by Hannover Medical School.
Recruitment status was:  Not yet recruiting
First Posted : March 31, 2010
Last Update Posted : March 31, 2010
Sponsor:
Information provided by:
Hannover Medical School

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Sitagliptin Drug: Placebo Other: Control Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metabolism-independent Vascular Effects of the Dipetidylpeptidase-4-inhibitor Sitagliptin in Patients With Type 2 Diabetes Mellitus
Study Start Date : October 2010
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sitagliptin
100 mg sitagliptin per day for 2 weeks
Drug: Sitagliptin
oral tablets 100 mg per day for two weeks

Placebo Comparator: Placebo
1 placebo tablet per day for 2 weeks
Drug: Placebo
oral tablet, one per day for two weeks

No Intervention: Healthy Control
Healthy control subjects
Other: Control
no intervention




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 2 Diabetes mellitus

Exclusion Criteria:

  • Allergy to sitagliptin
  • Treatment with PPAR-gamma agonist

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096277


Contacts
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

Locations
Germany
Hannover Medical School Not yet recruiting
Hannover, Germany, 30625
Contact: Sajoscha A. Sorrentino, MD       sorrentino.sajoscha@mh-hannover.de   
Principal Investigator: Sajoscha A. Sorrentino, MD         
Sponsors and Collaborators
Hannover Medical School
Investigators
Principal Investigator: Sajoscha A. Sorrentino, M.D. Hannover Medical School

Responsible Party: Sajoscha A. Sorrentino, MD, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01096277     History of Changes
Other Study ID Numbers: MHH_NPH_SS_1/2010
MHH_NPH_SS_1/2010 ( Other Identifier: Hannover Medical School )
First Posted: March 31, 2010    Key Record Dates
Last Update Posted: March 31, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action