A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment 


Tracking Information

Start Date  ICMJEApril 2010
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2010)		Renal function: estimated glomerular filtration rate [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryNo Changes Posted
Current Secondary Outcome Measures ICMJE 
 (submitted: January 5, 2010)
  • Renal function: estimated glomerular filtration rate [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Effect on blood hemoglobin [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Safety, Tolerability: AEs, laboratory parameters [ Time Frame: AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment
Official Title  ICMJEEffects of 0.15 mg Aleglitazar on Renal Function in Patients With Type 2 Diabetes and Moderate Renal Impairment, as Compared to Actos®
Brief Summary

This multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses. In addition, a diet and exercise plan will also be implemented during the anticipated time on study treatment of 52 weeks. The target sample size is 200-400 patients.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEDiabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Aleglitazar
    Aleglitazar 150 mcg po daily for 52 weeks
  • Drug: pioglitazone
    Pioglitazone 45 mg po daily for 52 weeks
Study Arms / Comparison Groups
  • 1: Experimental
    Intervention: Drug: Aleglitazar
  • 2: Active Comparator
    Intervention: Drug: pioglitazone

Recruitment Information

Estimated Enrollment  ICMJE300
Estimated Completion DateFebruary 2013
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients >/= 18 years of age
  • Diabetes mellitus, Type 2
  • Moderately impaired kidney function
  • Drug naive or up to 2 antihyperglycemic medications at stable dose for over 1 month at screening
  • BMI 25-35

Exclusion Criteria:

  • Current or previous treatment with a thiazolidinedione
  • Current or previous treatment with insulin
  • Treatment with fibrates <3 months prior to screening
  • History of renal disease other than diabetic nephropathy
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: BC22419888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEAustralia,   Brazil,   Colombia,   El Salvador,   Germany,   Hong Kong,   Hungary,   Italy,   Mexico,   Peru,   Romania,   Russian Federation,   Slovakia

Administrative Information

NCT ID  ICMJENCT01043029
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEBC22419, 2009-012270-12
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche