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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00461006

Enrollment

176

Registered

2007-04-17

Start date

2007-06-30

Completion date

2008-09-30

Last updated

2016-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

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.

Interventions

DRUGActos

45mg po daily

DRUGaleglitazar

0.6mg po daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Relative change from baseline in glomerular filtration rate	26 weeks

Secondary

Measure	Time frame
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

Countries

Mexico, Puerto Rico, Russia, Ukraine, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026