A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment

Effects of 150 mcg Aleglitazar on Renal Function in Patients With Type 2 Diabetes and Moderate Renal Impairment, as Compared to Actos®

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01043029

Enrollment

302

Registered

2010-01-06

Start date

2010-05-31

Completion date

2012-07-31

Last updated

2016-11-02

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 multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses. In addition, a diet and exercise plan will also be implemented during the anticipated time on study treatment of 52 weeks. The target sample size is 200-400 patients.

Interventions

DRUGaleglitazar

Aleglitazar 150 mcg po daily for 52 weeks

DRUGpioglitazone

Pioglitazone 45 mg po daily for 52 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients \>/= 18 years of age * Diabetes mellitus, Type 2 * Moderately impaired kidney function * Drug naive or up to 2 antihyperglycemic medications at stable dose for over 1 month at screening * BMI 25-35

Exclusion criteria

* Current or previous treatment with a thiazolidinedione * Current or previous treatment with insulin * Treatment with fibrates \<3 months prior to screening * History of renal disease other than diabetic nephropathy

Design outcomes

Primary

Measure	Time frame
Renal function: estimated glomerular filtration rate	Week 60

Secondary

Measure	Time frame
Safety, Tolerability: Adverse events (AEs), laboratory parameters	AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60
Renal function: estimated glomerular filtration rate	Week 52
Effect on blood hemoglobin	Week 52

Countries

Australia, Brazil, Colombia, El Salvador, Germany, Hong Kong, Hungary, Italy, Mexico, Peru, Romania, Russia, Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026