NCT01552018

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

June 18, 2014

Status Verified

June 1, 2014

Enrollment Period

1.9 years

First QC Date

February 22, 2012

Last Update Submit

June 17, 2014

Conditions

Coronary Artery DiseaseDiabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • Inflammatory biomarkers

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

    Changes in biomarkers from baseline to 3 months

Secondary Outcomes (1)

  • Gene expression of DPP-4 in adipose tissue and leukocytes

    Change in expression level of DPP-4 from baseline to 3 months

Study Arms (2)

Saxagliptin

ACTIVE COMPARATOR

Saxagliptin 5 mg/day

Drug: Saxagliptin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

SaxagliptinDRUG

Saxagliptin 5 mg, 1 tablet per day for 3 months

Also known as: Onglyza
Saxagliptin
PlaceboDRUG

Placebo, 1 tablet per day for 3 months.

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Heart Research, Dept. of Cardiology, Oslo University Hospital Ullevaal

Oslo, N-0424, Norway

Location

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes Mellitus, Type 2

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ida U Njerve, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2012

First Posted

March 13, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

June 18, 2014

Record last verified: 2014-06

Locations

NO(1)