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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043029
• Other study ID #: BC22419
• Secondary ID: 2009-012270-12
• Status: Completed
• Phase: Phase 2
• First received: January 5, 2010
• Last updated: November 1, 2016
• Start date: May 2010
• Est. completion date: July 2012

Study information

• Verified date: November 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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
• Renal Insufficiency

Intervention

Drug:
• aleglitazar
Aleglitazar 150 mcg po daily for 52 weeks
• pioglitazone
Pioglitazone 45 mg po daily for 52 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function: estimated glomerular filtration rate		Week 60	No
Secondary	Safety, Tolerability: Adverse events (AEs), laboratory parameters		AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60	No
Secondary	Renal function: estimated glomerular filtration rate		Week 52	No
Secondary	Effect on blood hemoglobin		Week 52	No