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

Novartis

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Canakinumab; Drug: Placebo; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00605475

CACZ885A2213

Details and patient eligibility

About

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).

Enrollment: 231 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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231 participants in 2 patient groups, including a placebo group

Canakinumab

Experimental group

Description:

Eligible participants were assigned to receive canakinumab in one of four cohorts; 1) Single IV infusion of canakinumab 0.3 mg/kg; 2) Singe IV infusion of canakinumab 10 mg/kg; 3) single IV infusion of canakinumab 0.1 mg/kg or 0.3 mg/kg, or 1.5 mg/kg; 4) Single IV injection of canakinumab 0.03 mg/kg. All participants were required to take a concomitant stable daily dose of metformin during the study.

Treatment:

Drug: Metformin

Drug: Canakinumab

Placebo

Placebo Comparator group

Description:

Eligible participants were assigned to receive placebo to canakinumab in one of four cohorts; 1) Single IV infusion of placebo to canakinumab 0.3 mg/kg; 2) Singe IV infusion of placebo to canakinumab 10 mg/kg; 3) single IV infusion of placebo to canakinumab 0.1 mg/kg or 0.3 mg/kg, or 1.5 mg/kg; 4) Single IV injection of placebo to canakinumab 0.03 mg/kg. All participants were required to take a concomitant stable daily dose of metformin during the study.

Treatment:

Drug: Metformin

Drug: Placebo