A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.

Diabetes Mellitus Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461058
• Other study ID #: BC20265
• Status: Completed
• Phase: Phase 2
• First received: April 16, 2007
• Last updated: August 3, 2016
• Start date: May 2007
• Est. completion date: December 2007

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Heart Failure

Intervention

Drug:
• Actos
Titrated to an individual maximum tolerated dose up to 45mg p.o. daily
• aleglitazar
Titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Israel,  Mexico,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period.		26 week	No
Secondary	Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period, adverse events (AEs), laboratory parameters.		26 week	No
Secondary	Efficacy: Change from baseline to week 26 in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), fasting plasma insulin (FPI) and lipid profile.		26 week	No