NCT00605475 - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes | Biotech Hunter

Enrollment

231

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions

Type 2 Diabetes Mellitus

Interventions

DRUG

Canakinumab

Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.

DRUG

Placebo

Placebo to Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.

DRUG

Metformin

Participants continued on their stable daily dose of metformin throughout the study

Trial Locations (13)

21286

International Research Center Towson, MD

33169

Allied Research International - Cetero Research Miami, Miami

Elite Research Institute Miami, Miami

72202

Arkansas Research Medical Testing, Little Rock

97239

Covance Clinical Research Unit Inc, Portland

98418

Charles River Clinical Services, Northwest Tacoma

Unknown

Novartis Investigator Site, Berlin

Novartis Investigator Site, Kiel

Novartis Investigator Site, Mönchengladbach

Novartis Investigator Site, Munich

Novartis Investigative Site, Neuss

Novartis Investigative Site, Moscow

Novartis Investigative Site, Saint Petersberg