Vascular Effects of Sitagliptin in Diabetes Mellitus

Hannover Medical School (MHH)

Status and phase: Unknown; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Control; Drug: Sitagliptin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01096277

MHH_NPH_SS_1/2010 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Type 2 Diabetes mellitus

Exclusion criteria

• Allergy to sitagliptin
• Treatment with PPAR-gamma agonist

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 3 patient groups, including a placebo group

Sitagliptin

Active Comparator group

Description:

100 mg sitagliptin per day for 2 weeks

Treatment:

Drug: Sitagliptin

Placebo

Placebo Comparator group

Description:

1 placebo tablet per day for 2 weeks

Treatment:

Drug: Placebo

Healthy Control

No Intervention group

Description:

Healthy control subjects

Treatment:

Other: Control