Saxagliptin and Atherosclerosis

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-02-28

Brief Summary

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Dipeptidyl peptidase 4 (DPP-4) inhibitors are approved as add on therapy to improve glycaemic control in Type 2 Diabetes Mellitus (T2DM). DPP-4 inactivates the incretin hormone glucagon-like peptide 1 (GLP-1). Inhibiting the inactivation of GLP-1 leads to increased insulin- and reduced glucagon secretion after meals. DPP-4 has been shown to be present in atherosclerotic plaques. DPP-4 is a protease with substrates including cytokines and chemokines associated with atherosclerosis/inflammation.

The purpose of this study is to explore the effects of 3 months intervention with DPP-4 inhibitor saxagliptin on biomarkers related to atherosclerosis in patients with stable coronary artery disease (CAD) and T2DM, on circulating levels and on expression levels in circulating monocytes and adipose tissue.

A reduction in markers associated with atherosclerosis could indicate an antiatherosclerotic effect of DPP-4 inhibitors beyond glycaemic control alone.

Due to reduced sample size (recruitment problems) the main focus has changed and will now be on cellular aspects and gene regulation (initially secondary outcome measure).

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Detailed Description

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Conditions

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Coronary Artery Disease Diabetes Mellitus Type 2

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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Saxagliptin

Saxagliptin 5 mg/day

Group Type ACTIVE_COMPARATOR

Saxagliptin

Intervention Type DRUG

Saxagliptin 5 mg, 1 tablet per day for 3 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, 1 tablet per day for 3 months.

Interventions

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Saxagliptin

Saxagliptin 5 mg, 1 tablet per day for 3 months

Intervention Type DRUG

Placebo

Placebo, 1 tablet per day for 3 months.

Intervention Type DRUG

Other Intervention Names

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Onglyza

Eligibility Criteria

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Inclusion Criteria

* Patients \> 18, \< 80 years old, with type 2 diabetes mellitus and angiographically proven coronary artery disease.
* HbA1c \> 6.5% and under treatment with either metformin and/or glimepiride.

Exclusion Criteria

* Allergy or hypersensitivity to any of the drug's components.
* Heart failure in NYHA class III or IV.
* Severe liver failure, moderate or severe kidney failure
* Malignant disease.
* Active infectious disease.
* Acute coronary syndrome in the last 3 months.
* Pregnancy or breastfeeding.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No