A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00461006
First received: April 16, 2007
Last updated: July 7, 2014
Last verified: July 2014

April 16, 2007
July 7, 2014
June 2007
April 2009   (final data collection date for primary outcome measure)
Relative change from baseline in glomerular filtration rate [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Relative change from baseline in glomerular filtration rate after 26 weeks of treatment.
Complete list of historical versions of study NCT00461006 on ClinicalTrials.gov Archive Site
  • Relative change from baseline in ERPF and UACR [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Absolute change in HbAlc, FPG and FPI. [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Renal function: relative change from baseline in ERPF and UACR after 26 weeks of treatment. Efficacy: absolute change in HbAlc, FPG and FPI at end of treatment. Safety: AEs, laboratory parameters.
Not Provided
Not Provided
 
A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.
A Randomized, Double Blind Study to Compare the Effects of Aleglitazar and Actos on Glomerular Filtration Rate and Other Parameters of Renal Function in Patients With Type 2 Diabetes.

This 2 arm study will compare the effects of aleglitazar and Actos, added to pre existing oral antihyperglycemic therapy and/or diet and exercise, on renal funct ion in patients with type 2 diabetes, and normal or mildly impaired renal functi on. Eligible patients will be randomized to receive either aleglitazar 0.6mg p.o or Actos 45mg p.o. daily. Renal function and efficacy parameters will be asses sed at intervals during the treatment period. The anticipated time on study trea tment is 3-12 months, and the target sample size is 100-500 individuals.

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
    0.6mg po daily
  • Drug: Actos
    45mg po daily
  • Experimental: 1
    Intervention: Drug: aleglitazar
  • Active Comparator: 2
    Intervention: Drug: Actos
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes for >=1 month;
  • drug naive, or receiving stable oral antihyperglycemic medication;
  • HbAlc 6.5-10.0% at screening.

Exclusion Criteria:

  • type 1 diabetes;
  • current or previous treatment with insulin;
  • history of renal disease other than diabetic nephropathy;
  • uncontrolled hypertension;
  • clinically significant cardiovascular disease;
  • CHF NYHA 3-4.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Mexico,   Puerto Rico,   Russian Federation,   Ukraine
 
NCT00461006
BC20653
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

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