A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and Class II Heart Failure.
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/3/2016 |
| Start Date: | May 2007 |
| End Date: | February 2008 |
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.
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.
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.
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.
We found this trial at
11
sites
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