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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01043029
First received: January 5, 2010
Last updated: October 6, 2014
Last verified: October 2014

January 5, 2010
October 6, 2014
May 2010
July 2012   (final data collection date for primary outcome measure)
Renal function: estimated glomerular filtration rate [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01043029 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment
Effects of 150 mcg Aleglitazar on Renal Function in Patients With Type 2 Diabetes and Moderate Renal Impairment, as Compared to Actos®

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: aleglitazar
    Aleglitazar 150 mcg po daily for 52 weeks
  • Drug: pioglitazone
    Pioglitazone 45 mg po daily for 52 weeks
  • Experimental: 1
    Intervention: Drug: aleglitazar
  • Active Comparator: 2
    Intervention: Drug: pioglitazone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
302
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   Colombia,   El Salvador,   Germany,   Hong Kong,   Hungary,   Italy,   Mexico,   Peru,   Romania,   Russian Federation,   Slovakia
 
NCT01043029
BC22419, 2009-012270-12
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP