Vascular Effects of Sitagliptin in Diabetes Mellitus

Phase 4

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Other: Control; Drug: Sitagliptin

• Registration Number: NCT01096277
• Lead Sponsor: 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

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 Timeline

• Status Verified: 2010-03
• Study First Submitted: 2010-03-26
• Study First Submitted QC: 2010-03-30
• Last Update Submitted: 2010-03-30
• Study First Posted: 2010-03-31
• Last Update Posted: 2010-03-31
• Study Start: 2010-10
• Primary Completion: 2011-11
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Type 2 Diabetes mellitus

Exclusion Criteria

• Allergy to sitagliptin
• Treatment with PPAR-gamma agonist

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1 placebo tablet per day for 2 weeks
Healthy Control	Control	Healthy control subjects
Sitagliptin	Sitagliptin	100 mg sitagliptin per day for 2 weeks

Primary Outcome Measures

Name	Time	Method
Endothelial function	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

Name	Time	Method
Effect on EPCs	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

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Germany