Text Size

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
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Sitagliptin
Drug: Placebo
Other: Control
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 70
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sitagliptin
100 mg sitagliptin per day for 2 weeks
 Drug: Sitagliptin
oral tablets 100 mg per day for two weeks
Other Name: Sitagliptin
Placebo Comparator: Placebo
1 placebo tablet per day for 2 weeks
 Drug: Placebo
oral tablet, one per day for two weeks
Other Name: Placebo
No Intervention: Healthy Control
Healthy control subjects
 Other: Control
no intervention
Other Name: Control

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 2 Diabetes mellitus

Exclusion Criteria:

  • Allergy to sitagliptin
  • Treatment with PPAR-gamma agonist
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: March 26, 2010
Last Updated: March 30, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013