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


Tracking Information

Start Date  ICMJEDecember 2007
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: March 23, 2009)
  • Safety and tolerability of ACZ885 [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • Pharmacodynamic effect of ACZ885 on glycemic indexes [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: January 30, 2008)
  • Safety and tolerability of ACZ885 [ Time Frame: throughout the study ]
  • Pharmacodynamic effect of ACZ885 on glycemic indexes [ Time Frame: throughout the study ]
Change HistoryComplete list of historical versions of study NCT00605475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: March 23, 2009)
  • Pharmacodynamic effect of ACZ885 on pancreatic beta-cell function and insulin sensitivity [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Duration of action of ACZ885 [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Pharmacokinetic effect of ACZ885 in patients with Type 2 diabetes [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: January 30, 2008)
  • Pharmacodynamic effect of ACZ885 on pancreatic beta-cell function and insulin sensitivity [ Time Frame: throughout the study ]
  • Duration of action of ACZ885 [ Time Frame: throughout the study ]
  • Pharmacokinetic effect of ACZ885 in patients with Type 2 diabetes [ Time Frame: throughout the study ]

Descriptive Information

Brief Title  ICMJESafety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes
Official Title  ICMJEA Multi Center, Randomized, Double Blind, Placebo-controlled, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 Administered Intravenously to Patients With Type 2 Diabetes Mellitus
Brief Summary

The purpose of this study is to evaluate, in patients with Type 2 Diabetes Mellitus, whether ACZ885 can lower HbA1c and/or peak glucose levels in response to an oral glucose tolerance test (OGTT).

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEType 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: ACZ885
  • Drug: Placebo
    Other Name: Placebo
Study Arms / Comparison Groups
  • 1: Experimental
    Intervention: Drug: ACZ885
  • 2: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE231
Completion Date 
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients aged 18 to 70 years, with type 2 diabetes mellitus (non-insulin dependent diabetes)
  • 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

GenderBoth
Ages18 Years to 70 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novartis862 778 8300
Location Countries  ICMJEUnited States,   Germany,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00605475
Responsible PartyExternal Affairs, Novartis
Study ID Numbers  ICMJECACZ885A2213
Study Sponsor  ICMJENovartis
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:NOVARTISNovartis investigator site
Information Provided ByNovartis