A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: aleglitazar (Drug); Actos (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Relative change from baseline in glomerular filtration rate
Secondary outcome: Relative change from baseline in ERPF and UACRAbsolute change in HbAlc, FPG and FPI. AEs, laboratory parameters.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
MEXICO CITY 11650, Mexico
ZAPOPAN 45200, Mexico
MONTERREY 64000, Mexico
MEXICO CITY 14050, Mexico
TLALPAN 14000, Mexico
HERMOSILLO 83067, Mexico
METEPEC EMEX52140, Mexico
CHIHUAHUA 31238, Mexico
MOSCOW 129110, Russian Federation
MOSCOW 12584, Russian Federation
MOSCOW 127299, Russian Federation
MOSCOW 150062, Russian Federation
ST PETERSBURG 197198, Russian Federation
SARATOV 410038, Russian Federation
MOSCOW 109472, Russian Federation
TUMEN 625023, Russian Federation
MOSCOW 125284, Russian Federation
ST PETERSBURG 191025, Russian Federation
ST PETERSBURG 198205, Russian Federation
ST PETERSBURG 199106, Russian Federation
KIEV 2091, Ukraine
KIEV 2125, Ukraine
DONETSK 83114, Ukraine
KIEV 2153, Ukraine
DONETSK 83003, Ukraine
TERNOPIL 46002, Ukraine
LUGNANSK 91045, Ukraine
KHARKOV 61178, Ukraine
POLTAVA 36024, Ukraine
DNIPROPETROVS'K 49005, Ukraine
PEORIA, Arizona 85381, United States
JONESBORO, Arkansas 72401, United States
FRESNO, California 93720, United States
JACKSONVILLE, Florida 32216-4313, United States
OMAHA, Nebraska 68131, United States
ALTOONA, Pennsylvania 16602, United States
SAN ANTONIO, Texas 78284, United States
MIDLAND, Texas 79705, United States
Additional Information
Starting date: June 2007
Ending date: August 2008
Last updated: June 17, 2008
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