Saxagliptin and Atherosclerosis (SAXATH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01552018
First received: February 22, 2012
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Saxagliptin and Atherosclerosis. A Possible Role for Saxagliptin in the Prevention of Atherosclerosis Beyond Glucose Metabolism.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Inflammatory biomarkers [ Time Frame: Changes in biomarkers from baseline to 3 months ] [ Designated as safety issue: No ]
    A selection of biomarkers associated with atherosclerosis, circulating levels and gene expression levels in adipose tissue and leukocytes.


Secondary Outcome Measures:
  • Gene expression of DPP-4 in adipose tissue and leukocytes [ Time Frame: Change in expression level of DPP-4 from baseline to 3 months ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: March 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
Drug: Placebo
Placebo, 1 tablet per day for 3 months.
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552018

Locations
Norway
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
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01552018     History of Changes
Other Study ID Numbers: 2011/773b (REK)
Study First Received: February 22, 2012
Last Updated: June 17, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency

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

ClinicalTrials.gov processed this record on July 28, 2014