Clinical trial NCT00461058: A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-04-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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;
* 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.

Primary outcomes:
measure: Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period.
timeFrame: 26 week
Secondary outcomes:
measure: Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period, adverse events (AEs), laboratory parameters.
timeFrame: 26 week
measure: Efficacy: Change from baseline to week 26 in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), fasting plasma insulin (FPI) and lipid profile.
timeFrame: 26 week
Other outcomes:
Locations:
city: Jonesboro
country: United States
state: Arkansas
city: Carmichael
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Slidell
country: United States
state: Louisiana
city: Minneapolis
country: United States
state: Minnesota
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Ashkelon
country: Israel
city: Haifa
country: Israel
city: Kfar Saba
country: Israel
city: Culiacan
country: Mexico
city: Guadalajara
country: Mexico
city: Metepec
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Pachuca
country: Mexico
city: San Luis Potosi
country: Mexico
city: Arad
country: Romania
city: Bacau
country: Romania
city: Baia Mare
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Oradea
country: Romania
city: Ploiesti
country: Romania
city: Targoviste
country: Romania
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saratov
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Donetsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkov
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: