Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00995930
First received: October 15, 2009
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

This study will evaluate the effect of ACZ885 on vascular function in patients with documented atherosclerotic disease and T2DM or IGT.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Atherosclerosis
Prediabetic State
Drug: ACZ885 (Canakinumab)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi Center, Randomized , Double Blind, Placebo-controlled, Study of the Safety, Tolerability, and Effects on Arterial Structure and Function of ACZ885 in Patients With Clinically Evident Atherosclerosis and Either T2DM or IGT

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: Safety, tolerability, and effect of monthly sc administration of ACZ885 on an integrated analysis of vascular function in subjects with atherosclerosis and T2DM or IGT [ Time Frame: 12 weeks and 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measure: Assess the effect of ACZ885 on aortic pulse wave velocity, plaque composition, arterial strain [ Time Frame: 12 weeks and 48 weeks ] [ Designated as safety issue: No ]
  • Evaluate the effect of ACZ885 on hsCRP [ Time Frame: 12 weeks and 48 weeks ] [ Designated as safety issue: No ]
  • Assess the pharmacokinetics of ACZ885 in patients with atherosclerosis [ Time Frame: 12 weeks and 48 weeks ] [ Designated as safety issue: No ]
  • Assess the effect of ACZ885 on glycemic parameters, including HbA1c and peak glucose levels 2 hours post the administration of an OGTT [ Time Frame: 12 weeks and 48 weeks ] [ Designated as safety issue: No ]
  • Assess the effect of ACZ885 on beta cell function and insulin resistance [ Time Frame: 12 weeks and 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 189
Study Start Date: December 2009
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACZ885 Drug: ACZ885 (Canakinumab)
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with known atherosclerotic disease and documented diagnosis of T2DM for ≤ 14 years OR IGT
  • HbA1c between 6.0% and 10.0%
  • On stable statin therapy or statin intolerant
  • Patients who are eligible and able to participate in the study

Exclusion Criteria:

  • Contraindications to MRI
  • NYHA class IV Heart Failure
  • NYHA class I - III heart failure with acute exacerbation in 3 months prior to screening
  • Patients with type 1 diabetes
  • Acute infections
  • HsCRP > 30 mg/dL
  • Aortic aneurysm ≥5cm

Other protocol-defined inclusion/exclusion criteria may apply

  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: NCT00995930

Locations
United States, New York
Novartis Investigative Site
New York, New York, United States, 10029
United States, Ohio
Novartis Investigative Site
Cincinnati, Ohio, United States, 45219
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H1T 1C8
Germany
Novartis Investigative Site
Mainz, Germany, 55116
Novartis Investigative Site
Neuss, Germany, 41460
Novartis Investigative Site
Ulm, Germany, 89081
Israel
Novartis Investigative Site
Jerusalem, Israel, 91120
United Kingdom
Novartis Investigative Site
Oxford, UK, United Kingdom, OX2 6HE
Novartis Investigative Site
London, United Kingdom, EC1M 6BQ
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00995930     History of Changes
Other Study ID Numbers: CACZ885I2206, 2009-014618-80
Study First Received: October 15, 2009
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Paul-Ehrlich-Institut
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Ministry of Health

Keywords provided by Novartis:
Atherosclerosis,
Type 2 Diabetes Mellitus,
Cardiovascular Diseases

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Arterial Occlusive Diseases
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014