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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Antibodies, Monoclonal; Metformin

Criteria

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