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: October 6, 2014
Last verified: October 2014

April 16, 2007
October 6, 2014
May 2007
February 2008   (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. [ 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., AEs, lab. parameters. Efficacy: Change from baseline to week 26 in HbAlc, FPG, FPI and lipid profile. [ 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.
Not Provided
Not Provided
 
A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and 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 aleglitaz ar and Actos in patients with type 2 diabetes and symptomatic NYHA class II hear t failure. Eligible patients will be randomized to receive either aleglitazar, t itrated 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 add ition to prescribed diabetes therapy where applicable. The anticipated time on s tudy 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: aleglitazar
1
Experimental: 1
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
February 2008
February 2008   (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;
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel,   Mexico,   Romania,   Russian Federation,   Ukraine
 
NCT00461058
BC20265
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

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