Clinical trial NCT00461006: A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-04-17
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Relative change from baseline in glomerular filtration rate
timeFrame: 26 weeks
Secondary outcomes:
measure: Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR)
timeFrame: 26 weeks
measure: Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI).
timeFrame: End of treatment
measure: Adverse events (AEs), laboratory parameters.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Peoria
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Fresno
country: United States
state: California
city: Los Gatos
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Omaha
country: United States
state: Nebraska
city: Charlotte
country: United States
state: North Carolina
city: Marion
country: United States
state: Ohio
city: Altoona
country: United States
state: Pennsylvania
city: Arlington
country: United States
state: Texas
city: Arlington
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Chihuahua
country: Mexico
city: Chihuahua
country: Mexico
city: Hermosillo
country: Mexico
city: Metepec
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Zapopan
country: Mexico
city: Manati
country: Puerto Rico
city: Ponce
country: Puerto Rico
city: Toa Baja
country: Puerto Rico
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saratov
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tumen
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Dnipropetrovs'k
country: Ukraine
city: Dnipropetrovs'k
country: Ukraine
city: Donetsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkov
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Lugnansk
country: Ukraine
city: Poltava
country: Ukraine
city: Ternopil
country: Ukraine
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: