Trial information
A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.
Status: Completed
Protocol number: BC20653
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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.
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. Target sample size is 176.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: aleglitazar
Primary outcome: 1. Relative change from baseline in glomerular filtration rate Time frame: 26 weeks
Key secondary outcomes: 1. Relative change from baseline in ERPF and UACR Time frame: 26 weeks
2. Absolute change in HbAlc, FPG and FPI. Time frame: End of treatment
3. AEs, laboratory parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 04/17/2007
Date last updated: 11/19/2009
Link to trial result
This trial was conducted at the following locations:
Mexico
- Chihuahua
- Hermosillo
- Metepec
- Mexico City
- Monterrey
- Zapopan
Russian Federation
- Moscow
- Saratov
- St Petersburg
- St. Petersburg
- Tumen
- Yaroslavl
Ukraine
- Dnipropetrovs'K
- Donetsk
- Kharkiv
- Kharkov
- Kiev
- Lugnansk
- Poltava
- Ternopil
United States
- Peoria, AZ
- Jonesboro, AR
- Fresno, CA
- Los Gatos, CA
- Mission Viejo, CA
- Jacksonville, FL
- Omaha, NE
- Charlotte, NC
- Marion, OH
- Altoona, PA
- Manati, PR
- Ponce, PR
- Toa Baja, PR
- Arlington, TX
- Dallas, TX
- Midland, TX
- San Antonio, TX
- Norfolk , VA
