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A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) 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: August 3, 2016
Last verified: August 2016

April 16, 2007
August 3, 2016
May 2007
December 2007   (final data collection date for primary outcome measure)
Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period. [ Time Frame: 26 week ] [ Designated as safety issue: No ]
Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics.
Complete list of historical versions of study NCT00461058 on ClinicalTrials.gov Archive Site
  • Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period, adverse events (AEs), laboratory parameters. [ Time Frame: 26 week ] [ Designated as safety issue: No ]
  • Efficacy: Change from baseline to week 26 in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), fasting plasma insulin (FPI) and lipid profile. [ Time Frame: 26 week ] [ Designated as safety issue: No ]
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.
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A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.
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.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • Drug: Actos
    Titrated to an individual maximum tolerated dose up to 45mg p.o. daily
  • Drug: aleglitazar
    Titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily
  • Active Comparator: Actos
    Intervention: Drug: Actos
  • Experimental: Aleglitazar
    Intervention: Drug: aleglitazar
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2007
December 2007   (final data collection date for primary outcome measure)

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;
  • HbA1c 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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel,   Mexico,   Romania,   Russian Federation,   Ukraine
Bulgaria
 
NCT00461058
BC20265
Not Provided
Not Provided
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP