Saxagliptin and Atherosclerosis (SAXATH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01552018
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : June 18, 2014
Information provided by (Responsible Party):
Oslo University Hospital

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
Coronary Artery Disease Diabetes Mellitus Type 2 Drug: Saxagliptin Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
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 : March 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
Drug Information available for: Saxagliptin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Saxagliptin
Saxagliptin 5 mg/day
Drug: Saxagliptin
Saxagliptin 5 mg, 1 tablet per day for 3 months
Other Name: Onglyza
Placebo Comparator: Placebo
Drug: Placebo
Placebo, 1 tablet per day for 3 months.

Primary Outcome Measures :
  1. Inflammatory biomarkers [ Time Frame: 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 [ Time Frame: Change in expression level of DPP-4 from baseline to 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01552018

Center for Clinical Heart Research, Dept. of Cardiology, Oslo University Hospital Ullevaal
Oslo, Norway, N-0424
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Ida U Njerve, MD Center for Clinical Heart Research, Dept. of Cardiology, Oslo University Hospital Ullevaal, Norway

Responsible Party: Oslo University Hospital Identifier: NCT01552018     History of Changes
Other Study ID Numbers: 2011/773b (REK)
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: June 18, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents