Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus Type 2
Drug: Actos
Drug: aleglitazar
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Relative change from baseline in glomerular filtration rate [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI). [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Adverse events (AEs), laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: June 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aleglitazar Drug: aleglitazar
0.6mg po daily
Active Comparator: Actos Drug: Actos
45mg po daily

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461006

  Show 52 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00461006     History of Changes
Other Study ID Numbers: BC20653 
Study First Received: April 16, 2007
Last Updated: July 28, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016