A Comparative Study of Aleglitazar and Actos® in Patients With Type 2 Diabetes Mellitus and Class II Heart Failure.

This study has been terminated.

( Exploratory study proactively terminated by Roche after slow enrollment due to concerns regarding the CV safety profile of TZDs in patients with symptomatic CHF )

First Received: April 16, 2007 Last Updated: December 14, 2007 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00461058

Purpose

This study will compare the safety, tolerability and efficacy of aleglitazar and Actos® in patients with type 2 diabetes and symptomatic NYHA class II heart failure. Eligible patients will be randomized to receive either aleglitazar, titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily, or Actos®, titrated to an individual maximum tolerated dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NB. In light of recent analyses of the cardiovascular safety profile of the thiazolidinediones, there has been increasing concern about the use of these medications in patients with symptomatic CHF as was planned in this study, resulting in a slow enrollment process of patients with symptomatic heart failure. However, as a proactive measure, Roche has taken the decision to terminate this exploratory study, effective immediately.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double Blind Study to Compare the Safety and Tolerability of Aleglitazar and Actos in Patients With Type 2 Diabetes and NYHA Class II Heart Failure.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Heart Failure

Drug Information available for: Aleglitazar

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics.

Secondary Outcome Measures:

Safety: peripheral oedema, deterioration of heart failure, increase in body weight, AEs, lab. parameters. Efficacy: Change from baseline to end of treatment in HbAlc, FPG, FPI and lipid profile.

Study Start Date:

June 2007

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;
type 2 diabetes for >=1 month;
drug naive, or receiving stable doses of <=2 oral antihyperglycemic medications;
HbAlc 6.5-10.0% at screening;
symptomatic, stable NYHA class 2 heart failure at screening.

Exclusion Criteria:

type 1 diabetes;
current or previous treatment with insulin;
uncontrolled hypertension;
NYHA class 1, 3 or 4 at screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461058

Show 73 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

More Information

No publications provided

Study ID Numbers:	BC20265
Study First Received:	April 16, 2007
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00461058 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Metabolic Diseases
Pioglitazone
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Metabolic Diseases
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 04, 2009