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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01043029
First Posted: January 6, 2010
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
January 5, 2010
January 6, 2010
November 2, 2016
May 2010
July 2012   (Final data collection date for primary outcome measure)
Renal function: estimated glomerular filtration rate [ Time Frame: Week 60 ]
Same as current
Complete list of historical versions of study NCT01043029 on ClinicalTrials.gov Archive Site
  • Safety, Tolerability: Adverse events (AEs), laboratory parameters [ Time Frame: AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60 ]
  • Renal function: estimated glomerular filtration rate [ Time Frame: Week 52 ]
  • Effect on blood hemoglobin [ Time Frame: Week 52 ]
  • Renal function: estimated glomerular filtration rate [ Time Frame: Week 52 ]
  • Effect on blood hemoglobin [ Time Frame: Week 52 ]
  • Safety, Tolerability: AEs, laboratory parameters [ Time Frame: AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60 ]
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 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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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: aleglitazar
    Intervention: Drug: aleglitazar
  • Active Comparator: pioglitazone
    Intervention: Drug: pioglitazone
Ruilope L, Hanefeld M, Lincoff AM, Viberti G, Meyer-Reigner S, Mudie N, Wieczorek Kirk D, Malmberg K, Herz M. Effects of the dual peroxisome proliferator-activated receptor-α/γ agonist aleglitazar on renal function in patients with stage 3 chronic kidney disease and type 2 diabetes: a Phase IIb, randomized study. BMC Nephrol. 2014 Nov 18;15:180. doi: 10.1186/1471-2369-15-180.

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
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
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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