Saxagliptin and Atherosclerosis

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StaðaLokið

Styrktaraðilar

Oslo University Hospital

KLÍNÍSK RANNSÓKN: NCT01552018

BioSeek: NCT01552018

Lykilorð

Útdráttur

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).

Dagsetningar

Síðast staðfest:	05/31/2014
Fyrst lagt fram:	02/21/2012
Áætluð skráning lögð fram:	03/07/2012
Fyrst sent:	03/12/2012
Síðasta uppfærsla lögð fram:	06/16/2014
Síðasta uppfærsla sett upp:	06/17/2014
Raunverulegur upphafsdagur náms:	02/29/2012
Áætlaður aðallokunardagur:	01/31/2014
Áætlaður dagsetningu rannsóknar:	01/31/2014

Ástand eða sjúkdómur

Coronary Artery Disease

Diabetes Mellitus Type 2

Íhlutun / meðferð

Drug: Saxagliptin

Drug: Placebo

Stig

Stig 4

Armhópar

Armur	Íhlutun / meðferð
Active Comparator: Saxagliptin Saxagliptin 5 mg/day	Drug: Saxagliptin Saxagliptin 5 mg, 1 tablet per day for 3 months
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo, 1 tablet per day for 3 months.

Hæfniskröfur

Aldur hæfur til náms	18 Years Til 18 Years
Kyn sem eru hæf til náms	All
Tekur við heilbrigðum sjálfboðaliðum	Já
Viðmið	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.

Útkoma

Aðal niðurstöður ráðstafanir

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.

Aðgerðir vegna aukaatriða

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

Saxagliptin and Atherosclerosis

Lykilorð

athyglisbrestur

peptidase

protease

bólga

atherosclerosis

diabetes mellitus type 2

sykursýki

kransæðasjúkdómar