[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

602-277-5551

Email address

John.Rasmussen@va.gov

Condition

Type 2 Diabetes

Treatment type

Interventional

Investigational product

Bydureon

Phase

Phase 4

Sponsor

Phoenix VA Health Care System

ClinicalTrials.gov identifier

NCT02162550

Study number

1026

Date first posted

May 27, 2014

Date last update

February 8, 2017

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About the study

Investigators will be determining whether a once weekly injectable medication Bydureon versus placebo is able to reduce the development of atherosclerosis. Investigators are testing the overall hypothesis that 18 months of Bydureon treatment will improve cardiovascular risk factors, endothelial function and retard carotid atherosclerosis plaque progression in type 2 diabetes mellitus (T2DM). Investigators anticipate these studies will provide novel information about the temporal relationship between Bydureon induced changes in risk factors, endothelial function and atherosclerosis progression.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. males and females of any race and ethnicity with T2DM, HbA1c of ≥6.5% and ≤10.0% on diet only
  2. take stable doses of oral antihyperglycemic agents with or without long-acting insulin
  3. must have a regular primary care provider (PCP) that is amenable to patient study participation and will facilitate (blinded to the treatment) the research team's study protocol efforts
Exclusion criteria
  1. type 1 diabetes mellitus (T1DM)
  2. current or recent glucagon-like peptide 1 receptor (GLP-1R) agonist use
  3. contraindications to MRI (e.g., claustrophobia, ferromagnetic materials, body habitus inappropriate for MRI exam)
  4. screening carotid ultrasound plaque thickness of <0.75 mm, prior or anticipated carotid stenting or endarterectomy
  5. recent CVD (past 6 months) or other major illness or conditions affecting risk (e.g., pancreatitis, severe renal disease) or personal or family history of medullary thyroid carcinoma
  6. patients with Multiple Endocrine Neoplasia syndrome type 2
  7. serious hypersensitivity to exenatide or any product components
  8. severe gastrointestinal disease, or pregnancy

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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