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

Sponsors

Lead Sponsor: Novartis Pharmaceuticals

Source Novartis
Brief Summary

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

Overall Status Completed
Start Date December 2009
Completion Date February 2014
Primary Completion Date February 2014
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants With Adverse Events, Serious Adverse Events and Death 12 months
Change From Baseline in Aortic Distensibility baseline, 3 months, 12 months
Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area) baseline, 3 months, 12 months
Secondary Outcome
Measure Time Frame
Change From Baseline in Pulse Wave Velocity and Pulse Wave Velocity Error baseline, 3 months, 12 months
Change From Baseline in Plaque Composition baseline, 3 months, 12 months
Change From Baseline in Aortic Strain baseline, 3 months, 12 months
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) baseline, 3 months, 12 months
Change From Baseline in Fasting Plasma Glucose baseline, 3 months, 12 months
Change From Baseline in Hemoglobin A1c (HbA1c) baseline, 3 months, 12 months
Change From Baseline in 2 Hour Glucose Post Oral Glucose Tolerance Test (OGTT) baseline, 3 months, 12 months
Change From Baseline in Beta Cell Function (HOMA-B) baseline, 3 months, 12 months
Change From Baseline Insulin Resistance (HOMA-IR) baseline, 3 months, 12 months
Pharmacokinetics: ACZ885 Serum Concentrations 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
Enrollment 189
Condition
Intervention

Intervention Type: Drug

Intervention Name: ACZ885

Description: ACZ885 150 mg was administered subcutaneously once a month for 12 months.

Arm Group Label: ACZ885

Other Name: Canakinumab

Intervention Type: Drug

Intervention Name: Placebo

Description: Matching placebo to ACZ885 was administered subcutaneously once a month for 12 months.

Arm Group Label: Placebo

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 74 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Location
Facility:
Novartis Investigative Site | New York, New York, 10029, United States
Novartis Investigative Site | Cincinnati, Ohio, 45219, United States
Novartis Investigative Site | Montreal, Quebec, H1T 1C8, Canada
Novartis Investigative Site | Mainz, 55116, Germany
Novartis Investigative Site | Neuss, 41460, Germany
Novartis Investigative Site | Ulm, 89081, Germany
Novartis Investigative Site | Jerusalem, 91120, Israel
Novartis Investigative Site | Oxford, UK, OX2 6HE, United Kingdom
Novartis Investigative Site | London, EC1M 6BQ, United Kingdom
Location Countries

Canada

Germany

Israel

United Kingdom

United States

Verification Date

June 2015

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Placebo

Type: Placebo Comparator

Description: subcutaneous (SQ) monthly

Label: ACZ885

Type: Experimental

Description: 150 mg SQ monthly

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov