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Vascular Effects of Sitagliptin in Diabetes Mellitus

NCT ID: NCT01096277

Last Updated: 2010-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sitagliptin

100 mg sitagliptin per day for 2 weeks

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

oral tablets 100 mg per day for two weeks

Placebo

1 placebo tablet per day for 2 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral tablet, one per day for two weeks

Healthy Control

Healthy control subjects

Group Type NO_INTERVENTION

Control

Intervention Type OTHER

no intervention

Interventions

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Sitagliptin

oral tablets 100 mg per day for two weeks

Intervention Type DRUG

Placebo

oral tablet, one per day for two weeks

Intervention Type DRUG

Control

no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetes mellitus

Exclusion Criteria

* Allergy to sitagliptin
* Treatment with PPAR-gamma agonist
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Hannover Medical School

Principal Investigators

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Sajoscha A. Sorrentino, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Hannover Medical School

Hanover, , Germany

Site Status

Countries

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Germany

Central Contacts

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Sajoscha A. Sorrentino, MD

Role: CONTACT

Phone: +49511532

Email: [email protected]

Bernhard M. Schmidt, MD

Role: CONTACT

Phone: +49511532

Email: [email protected]

Facility Contacts

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Sajoscha A. Sorrentino, MD

Role: primary

Other Identifiers

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MHH_NPH_SS_1/2010

Identifier Type: OTHER

Identifier Source: secondary_id

MHH_NPH_SS_1/2010

Identifier Type: -

Identifier Source: org_study_id