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

Roche

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: aleglitazar; Drug: Actos

Study type: Interventional

Funder types: Industry

Identifiers

NCT00461058

BC20265

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups

Actos

Active Comparator group

Treatment:

Drug: Actos

Aleglitazar

Experimental group

Treatment:

Drug: aleglitazar