Clinical trial NCT00995930: Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Atherosclerosis
Prediabetic State
Keywords: Atherosclerosis,
Type 2 Diabetes Mellitus, T2DM,
Cardiovascular Diseases, ACZ885, impaired glucose tolerance, IGT, Canakinumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-10-16
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of Participants With Adverse Events, Serious Adverse Events and Death
timeFrame: 12 months
measure: Change From Baseline in Aortic Distensibility
timeFrame: baseline, 3 months, 12 months
measure: Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area)
timeFrame: baseline, 3 months, 12 months
Secondary outcomes:
measure: Change From Baseline in Pulse Wave Velocity and Pulse Wave Velocity Error
timeFrame: baseline, 3 months, 12 months
measure: Change From Baseline in Plaque Composition
timeFrame: baseline, 3 months, 12 months
measure: Change From Baseline in Aortic Strain
timeFrame: baseline, 3 months, 12 months
measure: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)
timeFrame: baseline, 3 months, 12 months
measure: Change From Baseline in Fasting Plasma Glucose
timeFrame: baseline, 3 months, 12 months
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: baseline, 3 months, 12 months
measure: Change From Baseline in 2 Hour Glucose Post Oral Glucose Tolerance Test (OGTT)
timeFrame: baseline, 3 months, 12 months
measure: Change From Baseline in Beta Cell Function (HOMA-B)
timeFrame: baseline, 3 months, 12 months
measure: Change From Baseline Insulin Resistance (HOMA-IR)
timeFrame: baseline, 3 months, 12 months
measure: Pharmacokinetics: ACZ885 Serum Concentrations
timeFrame: pre-dose, 0.167 day post dose 1, 7 days post dose 1, 14 days post dose 1, every 30 days post each dose from doses 1 through 12, 60 days post dose 12, 90 days post dose 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Neuss
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Oxford
country: United Kingdom
facility: Novartis Investigative Site
state: UK
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Choudhury RP, Birks JS, Mani V, Biasiolli L, Robson MD, L'Allier PL, Gingras MA, Alie N, McLaughlin MA, Basson CT, Schecter AD, Svensson EC, Zhang Y, Yates D, Tardif JC, Fayad ZA. Arterial Effects of Canakinumab in Patients With Atherosclerosis and Type 2 Diabetes or Glucose Intolerance. J Am Coll Cardiol. 2016 Oct 18;68(16):1769-1780. doi: 10.1016/j.jacc.2016.07.768.