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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00461006

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: aleglitazar Drug: Actos	Phase II

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:	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.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Aleglitazar

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Relative change from baseline in glomerular filtration rate [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relative change from baseline in ERPF and UACR [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Absolute change in HbAlc, FPG and FPI. [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	176
Study Completion Date:	April 2009

Arms	Assigned Interventions
1: Experimental	Drug: aleglitazar 0.6mg po daily
2: Active Comparator	Drug: Actos 45mg po daily

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, 18-75 years of age;
type 2 diabetes for >=1 month;
drug naive, or receiving stable oral antihyperglycemic medication;
HbAlc 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;
CHF NYHA 3-4.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461006

Show 52 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 ( Clinical Trials, Study Director )
Study ID Numbers:	BC20653
Study First Received:	April 16, 2007
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00461006 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Pioglitazone
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 18, 2010