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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00461058
First received: April 16, 2007
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

This 2 arm 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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

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 during 26 week treatment period. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period., AEs, lab. parameters. Efficacy: Change from baseline to week 26 in HbAlc, FPG, FPI and lipid profile. [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: May 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: aleglitazar
1

  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 45 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: NCT00461058     History of Changes
Other Study ID Numbers: BC20265
Study First Received: April 16, 2007
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Failure
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013