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

Novartis

Status and phase: Completed; Phase 2

Conditions: Prediabetic State; Diabetes Mellitus, Type 2; Atherosclerosis

Treatments: Drug: ACZ885; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00995930

CACZ885I2206

2009-014618-80

Details and patient eligibility

About

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

Enrollment: 189 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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189 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

subcutaneous (SQ) monthly

Treatment:

Drug: Placebo

ACZ885

Experimental group

Description:

150 mg SQ monthly

Treatment:

Drug: ACZ885