Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes
NCT ID: NCT00605475
Last Updated: 2012-02-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
231 participants
INTERVENTIONAL
2007-12-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Canakinumab
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.
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.
Metformin
Participants continued on their stable daily dose of metformin throughout the study
Placebo
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.
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.
Metformin
Participants continued on their stable daily dose of metformin throughout the study
Interventions
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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.
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.
Metformin
Participants continued on their stable daily dose of metformin throughout the study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c between 7.0 and 9.5%
* On stable dose metformin monotherapy
* Stable body weight
Exclusion Criteria
* Acute infections prior to dosing
* Patients with type 1 diabetes (insulin-dependent diabetes)
* Taking diabetes medication (other than metformin)
18 Years
70 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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NOVARTIS
Role: PRINCIPAL_INVESTIGATOR
Novartis investigator site
Locations
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Arkansas Research Medical Testing
Little Rock, Arkansas, United States
Allied Research International - Cetero Research Miami
Miami, Florida, United States
Elite Research Institute Miami
Miami, Florida, United States
International Research Center Towson
MD, Maryland, United States
Covance Clinical Research Unit Inc
Portland, Oregon, United States
Charles River Clinical Services
Northwest Tacoma, Washington, United States
Novartis Investigator Site
Berlin, , Germany
Novartis Investigator Site
Kiel, , Germany
Novartis Investigator Site
Mönchengladbach, , Germany
Novartis Investigator Site
Munich, , Germany
Novartis Investigative Site
Neuss, , Germany
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Saint Petersberg, , Russia
Countries
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Other Identifiers
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CACZ885A2213
Identifier Type: -
Identifier Source: org_study_id
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