Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes

A Multi Center, Randomized, Double Blind, Placebo-controlled, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 Administered Intravenously to Patients With Type 2 Diabetes Mellitus

The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose levels in response to an oral glucose tolerance test (OGTT).

Inclusion Criteria:

• Male or female patients aged 18 to 70 years, with type 2 diabetes mellitus (non-insulin dependent diabetes) for at least 6 months prior to study start
• HbA1c between 7.0 and 9.5%
• On stable dose metformin monotherapy
• Stable body weight

Exclusion Criteria:

• Poorly controlled type 2 diabetes (very low or very high blood sugar levels, or other indicators of poor control)
• Acute infections prior to dosing
• Patients with type 1 diabetes (insulin-dependent diabetes)
• Taking diabetes medication (other than metformin)

Other protocol-defined inclusion/exclusion criteria may apply