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.
1 other identifier
interventional
176
5 countries
52
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 diabetes-mellitus-type-2
Started Jun 2007
Typical duration for phase_2 diabetes-mellitus-type-2
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2007
CompletedFirst Posted
Study publicly available on registry
April 17, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedAugust 1, 2016
July 1, 2016
1.3 years
April 16, 2007
July 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Relative change from baseline in glomerular filtration rate
26 weeks
Secondary Outcomes (3)
Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR)
26 weeks
Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI).
End of treatment
Adverse events (AEs), laboratory parameters.
Throughout study
Study Arms (2)
Aleglitazar
EXPERIMENTALActos
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Unknown Facility
Peoria, Arizona, 85381, United States
Unknown Facility
Jonesboro, Arkansas, 72401, United States
Unknown Facility
Fresno, California, 93720, United States
Unknown Facility
Los Gatos, California, 95032, United States
Unknown Facility
Mission Viejo, California, 92691, United States
Unknown Facility
Jacksonville, Florida, 32216-4313, United States
Unknown Facility
Omaha, Nebraska, 68131, United States
Unknown Facility
Charlotte, North Carolina, 28211, United States
Unknown Facility
Marion, Ohio, 43302, United States
Unknown Facility
Altoona, Pennsylvania, 16602, United States
Unknown Facility
Arlington, Texas, 76014, United States
Unknown Facility
Arlington, Texas, 76017, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Midland, Texas, 79707, United States
Unknown Facility
San Antonio, Texas, 78284, United States
Unknown Facility
Norfolk, Virginia, 23510, United States
Unknown Facility
Chihuahua City, 31238, Mexico
Unknown Facility
Chihuahua City, 31328, Mexico
Unknown Facility
Hermosillo, 83067, Mexico
Unknown Facility
Metepec, EMEX52140, Mexico
Unknown Facility
Mexico City, 11650, Mexico
Unknown Facility
Mexico City, 14000, Mexico
Unknown Facility
Mexico City, 14050, Mexico
Unknown Facility
Monterrey, 64000, Mexico
Unknown Facility
Zapopan, 45200, Mexico
Unknown Facility
ManatÃ, 00674, Puerto Rico
Unknown Facility
Ponce, 00717-322, Puerto Rico
Unknown Facility
Toa Baja, 00949, Puerto Rico
Unknown Facility
Moscow, 109472, Russia
Unknown Facility
Moscow, 125101, Russia
Unknown Facility
Moscow, 127299, Russia
Unknown Facility
Moscow, 127486, Russia
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Moscow, 129110, Russia
Unknown Facility
Saint Petersburg, 191025, Russia
Unknown Facility
Saint Petersburg, 197198, Russia
Unknown Facility
Saint Petersburg, 198205, Russia
Unknown Facility
Saint Petersburg, 199106, Russia
Unknown Facility
Saratov, 410038, Russia
Unknown Facility
Tyumen, 625023, Russia
Unknown Facility
Yaroslavl, 150062, Russia
Unknown Facility
Dnipro, 49005, Ukraine
Unknown Facility
Dnipro, 49060, Ukraine
Unknown Facility
Donetsk, 83003, Ukraine
Unknown Facility
Donetsk, 83114, Ukraine
Unknown Facility
Kharkiv, 61039, Ukraine
Unknown Facility
Kharkiv, 61178, Ukraine
Unknown Facility
Kiev, 02091, Ukraine
Unknown Facility
Kiev, 2091, Ukraine
Unknown Facility
Kiev, 2125, Ukraine
Unknown Facility
Lugnansk, 91045, Ukraine
Unknown Facility
Poltava, 36024, Ukraine
Unknown Facility
Ternopil, 46002, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2007
First Posted
April 17, 2007
Study Start
June 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
August 1, 2016
Record last verified: 2016-07