Saxagliptin and Atherosclerosis

Phase 4

Completed

• Conditions: Coronary Artery Disease; Diabetes Mellitus Type 2
• Interventions: Drug: Saxagliptin; Drug: Placebo

• Registration Number: NCT01552018
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-22
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-13
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saxagliptin	Saxagliptin	Saxagliptin 5 mg/day
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Gene expression of DPP-4 in adipose tissue and leukocytes	Change in expression level of DPP-4 from baseline to 3 months

Trial Locations

Locations (1)

Center for Clinical Heart Research, Dept. of Cardiology, Oslo University Hospital Ullevaal; 🇳🇴 Oslo, Norway