Trial information
A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and Class II Heart Failure.
Status: Completed
Protocol number: BC20265
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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.
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. Target sample size is 200.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: aleglitazar
Primary outcome: 1. Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period.
Key secondary outcomes: 1. 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.
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 04/17/2007
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Bulgaria
United States
