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

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. Identifier: NCT00461006
Recruitment Status : Completed
First Posted : April 17, 2007
Last Update Posted : August 1, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Actos Drug: aleglitazar Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : June 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Experimental: Aleglitazar Drug: aleglitazar
0.6mg po daily

Active Comparator: Actos Drug: Actos
45mg po daily

Primary Outcome Measures :
  1. Relative change from baseline in glomerular filtration rate [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR) [ Time Frame: 26 weeks ]
  2. Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI). [ Time Frame: End of treatment ]
  3. Adverse events (AEs), laboratory parameters. [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00461006

  Hide Study Locations
United States, Arizona
Peoria, Arizona, United States, 85381
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
United States, California
Fresno, California, United States, 93720
Los Gatos, California, United States, 95032
Mission Viejo, California, United States, 92691
United States, Florida
Jacksonville, Florida, United States, 32216-4313
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, North Carolina
Charlotte, North Carolina, United States, 28211
United States, Ohio
Marion, Ohio, United States, 43302
United States, Pennsylvania
Altoona, Pennsylvania, United States, 16602
United States, Texas
Arlington, Texas, United States, 76014
Arlington, Texas, United States, 76017
Dallas, Texas, United States, 75231
Midland, Texas, United States, 79707
San Antonio, Texas, United States, 78284
United States, Virginia
Norfolk, Virginia, United States, 23510
Chihuahua, Mexico, 31238
Chihuahua, Mexico, 31328
Hermosillo, Mexico, 83067
Metepec, Mexico, EMEX52140
Mexico City, Mexico, 11650
Mexico City, Mexico, 14000
Mexico City, Mexico, 14050
Monterrey, Mexico, 64000
Zapopan, Mexico, 45200
Puerto Rico
Manati, Puerto Rico, 00674
Ponce, Puerto Rico, 00717-322
Toa Baja, Puerto Rico, 00949
Russian Federation
Moscow, Russian Federation, 109472
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 127299
Moscow, Russian Federation, 127486
Moscow, Russian Federation, 129110
Saratov, Russian Federation, 410038
St Petersburg, Russian Federation, 191025
St Petersburg, Russian Federation, 197198
St Petersburg, Russian Federation, 198205
St. Petersburg, Russian Federation, 199106
Tumen, Russian Federation, 625023
Yaroslavl, Russian Federation, 150062
Dnipropetrovs'k, Ukraine, 49005
Dnipropetrovs'k, Ukraine, 49060
Donetsk, Ukraine, 83003
Donetsk, Ukraine, 83114
Kharkiv, Ukraine, 61039
Kharkov, Ukraine, 61178
Kiev, Ukraine, 02091
Kiev, Ukraine, 2091
Kiev, Ukraine, 2125
Lugnansk, Ukraine, 91045
Poltava, Ukraine, 36024
Ternopil, Ukraine, 46002
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00461006     History of Changes
Other Study ID Numbers: BC20653
First Posted: April 17, 2007    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: July 2016

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