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

October 15, 2009
May 20, 2014
December 2009
February 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00995930 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Atherosclerosis
  • Prediabetic State
  • Drug: ACZ885 (Canakinumab)
  • Drug: Placebo
  • Experimental: ACZ885
    Intervention: Drug: ACZ885 (Canakinumab)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
189
February 2014
February 2014   (final data collection date for primary outcome measure)

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

Both
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Israel,   United Kingdom
 
NCT00995930
CACZ885I2206, 2009-014618-80
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP