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

Completed · Phase 2

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT00461058

Run by

Hoffmann-La Roche

People needed

14

Starts

2007-05-01

Expected to finish

2007-12-01

Last updated by the study team

2016-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• type 1 diabetes;
• current or previous treatment with insulin;
• uncontrolled hypertension;
• NYHA class 1, 3 or 4 at screening.

Where it is running

• Study site — Jonesboro, Arkansas, United States
• Study site — Carmichael, California, United States
• Study site — Loma Linda, California, United States
• Study site — Long Beach, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Slidell, Louisiana, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Cleveland, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Ashkelon, Israel
• Study site — Haifa, Israel
• Study site — Kfar Saba, Israel
• Study site — Culiacán, Mexico
• Study site — Guadalajara, Mexico
• Study site — Metepec, Mexico
• Study site — Mexico City, Mexico
• Study site — Mexico City, Mexico
• Study site — Monterrey, Mexico
• Study site — Pachuca, Mexico
• Study site — San Luis Potosí City, Mexico
• Study site — Arad, Romania
• Study site — Bacau, Romania
• Study site — Baia Mare, Romania
• Study site — Bucharest, Romania

Full record on ClinicalTrials.gov

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