Status:
COMPLETED
A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ran...
Eligibility Criteria
Inclusion
- 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
- type 1 diabetes;
- current or previous treatment with insulin;
- uncontrolled hypertension;
- NYHA class 1, 3 or 4 at screening.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00461058
Start Date
May 1 2007
End Date
December 1 2007
Last Update
August 5 2016
Active Locations (45)
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1
Jonesboro, Arkansas, United States, 72401
2
Carmichael, California, United States, 95608
3
Loma Linda, California, United States, 92354
4
Long Beach, California, United States, 90822