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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 28, 2016
Last verified: July 2016
April 16, 2007
July 28, 2016
June 2007
September 2008   (Final data collection date for primary outcome measure)
Relative change from baseline in glomerular filtration rate [ Time Frame: 26 weeks ]
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 estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR) [ Time Frame: 26 weeks ]
  • Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI). [ Time Frame: End of treatment ]
  • Adverse events (AEs), laboratory parameters. [ Time Frame: Throughout study ]
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 preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function. 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 assessed at intervals during the treatment period. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • Drug: Actos
    45mg po daily
  • Drug: aleglitazar
    0.6mg po daily
  • Experimental: Aleglitazar
    Intervention: Drug: aleglitazar
  • Active Comparator: Actos
    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
September 2008
September 2008   (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;
  • HbA1c 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;
  • Congestive heart failure (CHF) New York Heart Association (NYHA) 3-4.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Mexico,   Puerto Rico,   Russian Federation,   Ukraine,   United States
Bulgaria,   Israel
 
NCT00461006
BC20653
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2016

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