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

Diabetes Mellitus Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461006
• Other study ID #: BC20653
• Status: Completed
• Phase: Phase 2
• First received: April 16, 2007
• Last updated: July 28, 2016
• Start date: June 2007
• Est. completion date: September 2008

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Actos
45mg po daily
• aleglitazar
0.6mg po daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Mexico,  Puerto Rico,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change from baseline in glomerular filtration rate		26 weeks	No
Secondary	Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR)		26 weeks	No
Secondary	Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI).		End of treatment	No
Secondary	Adverse events (AEs), laboratory parameters.		Throughout study	No