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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01043029
First received: January 5, 2010
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: aleglitazar
Drug: pioglitazone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of 150 mcg Aleglitazar on Renal Function in Patients With Type 2 Diabetes and Moderate Renal Impairment, as Compared to Actos®

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Renal function: estimated glomerular filtration rate [ Time Frame: Week 60 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety, Tolerability: AEs, laboratory parameters [ Time Frame: AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60 ] [ Designated as safety issue: No ]
  • Renal function: estimated glomerular filtration rate [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Effect on blood hemoglobin [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment: 302
Study Start Date: May 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: aleglitazar
Aleglitazar 150 mcg po daily for 52 weeks
Active Comparator: 2 Drug: pioglitazone
Pioglitazone 45 mg po daily for 52 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043029

  Show 80 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01043029     History of Changes
Other Study ID Numbers: BC22419, 2009-012270-12
Study First Received: January 5, 2010
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Endocrine System Diseases
Glucose Metabolism Disorders
Kidney Diseases
Metabolic Diseases
Urologic Diseases
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 28, 2014