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SAXATH: Saxagliptin and Atherosclerosis

Sponsor
Oslo University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01552018
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
23.1
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Saxagliptin and Atherosclerosis. A Possible Role for Saxagliptin in the Prevention of Atherosclerosis Beyond Glucose Metabolism.
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Saxagliptin

Saxagliptin 5 mg/day

Drug: Saxagliptin
Saxagliptin 5 mg, 1 tablet per day for 3 months
Other Names:
  • Onglyza

    		•
    Placebo Comparator: Placebo

    Placebo

    Drug: Placebo
    Placebo, 1 tablet per day for 3 months.

    Outcome Measures

    Primary Outcome Measures

    1. Inflammatory biomarkers [Changes in biomarkers from baseline to 3 months]

      A selection of biomarkers associated with atherosclerosis, circulating levels and gene expression levels in adipose tissue and leukocytes.

    Secondary Outcome Measures

    1. Gene expression of DPP-4 in adipose tissue and leukocytes [Change in expression level of DPP-4 from baseline to 3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Clinical Heart Research, Dept. of Cardiology, Oslo University Hospital Ullevaal Oslo Norway N-0424

    Sponsors and Collaborators

    • Oslo University Hospital

    Investigators

    • Principal Investigator: Ida U Njerve, MD, Center for Clinical Heart Research, Dept. of Cardiology, Oslo University Hospital Ullevaal, Norway

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT01552018
    Other Study ID Numbers:
    • 2011/773b (REK)
    First Posted:
    Mar 13, 2012
    Last Update Posted:
    Jun 18, 2014
    Last Verified:
    Jun 1, 2014
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Atherosclerosis
    Diabetes Mellitus, Type 2
    Saxagliptin

    Study Results

    No Results Posted as of Jun 18, 2014