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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Novartis
Study ID
NCT00605475
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Canakinumab — DRUG
    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 — DRUG
    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 — DRUG
    Participants continued on their stable daily dose of metformin throughout the study

Study Details

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).

Key Dates

Start date
Dec 31, 2007
Status verified
Jan 2012
Primary completion
Sep 30, 2010
Completion
Sep 30, 2010

Study Design

Enrollment
231 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

Mean Change From Baseline in Plasma HbA1c (Glycosylated Hemoglobin / Hemoglobin A1c) [ Time Frame: Baseline, Day 28, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Arkansas Research Medical TestingLittle RockArkansas72202-
Allied Research International - Cetero Research MiamiMiamiFlorida33169-
Elite Research Institute MiamiMiamiFlorida33169-
International Research Center TowsonMDMaryland21286-
Covance Clinical Research Unit IncPortlandOregon97239-
Charles River Clinical ServicesNorthwest TacomaWashington98418-

Find similar trials in Little Rock, AR

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Arkansas Research Medical Testing· Little Rock, ARAllied Research International - Cetero Research Miami· Miami, FLElite Research Institute Miami· Miami, FLInternational Research Center Towson· MD, MDCovance Clinical Research Unit Inc· Portland, ORCharles River Clinical Services· Northwest Tacoma, WA

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