A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.
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.
1 other identifier
interventional
14
6 countries
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes-mellitus-type-2
Started May 2007
Shorter than P25 for phase_2 diabetes-mellitus-type-2
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2007
CompletedFirst Posted
Study publicly available on registry
April 17, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedAugust 5, 2016
August 1, 2016
7 months
April 16, 2007
August 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period.
26 week
Secondary Outcomes (2)
Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period, adverse events (AEs), laboratory parameters.
26 week
Efficacy: Change from baseline to week 26 in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), fasting plasma insulin (FPI) and lipid profile.
26 week
Study Arms (2)
Actos
ACTIVE COMPARATORAleglitazar
EXPERIMENTALInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Unknown Facility
Jonesboro, Arkansas, 72401, United States
Unknown Facility
Carmichael, California, 95608, United States
Unknown Facility
Loma Linda, California, 92354, United States
Unknown Facility
Long Beach, California, 90822, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Slidell, Louisiana, 70458, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Oklahoma City, Oklahoma, 73112, United States
Unknown Facility
Tulsa, Oklahoma, 74104, United States
Unknown Facility
Ashkelon, 78278, Israel
Unknown Facility
Haifa, 31096, Israel
Unknown Facility
Kfar Saba, 44281, Israel
Unknown Facility
Culiacán, SIN80020, Mexico
Unknown Facility
Guadalajara, JAL44340, Mexico
Unknown Facility
Metepec, EMEX52140, Mexico
Unknown Facility
Mexico City, 11650, Mexico
Unknown Facility
Mexico City, DF7060, Mexico
Unknown Facility
Monterrey, 64000, Mexico
Unknown Facility
Pachuca, 42000, Mexico
Unknown Facility
San Luis Potosí City, SLP78250, Mexico
Unknown Facility
Arad, 310037, Romania
Unknown Facility
Bacau, 600114, Romania
Unknown Facility
Baia Mare, 430123, Romania
Unknown Facility
Bucharest, 010242, Romania
Unknown Facility
Bucharest, 20475, Romania
Unknown Facility
Bucharest, 50452, Romania
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Oradea, 410169, Romania
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Ploieşti, 100097, Romania
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Târgovişte, 130083, Romania
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Moscow, 123436, Russia
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Moscow, 125101, Russia
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Moscow, 127018, Russia
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Moscow, 127299, Russia
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Saint Petersburg, 191025, Russia
Unknown Facility
Saint Petersburg, 198205, Russia
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Saint Petersburg, 199106, Russia
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Saratov, 410028, Russia
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Yaroslavl, 150062, Russia
Unknown Facility
Donetsk, 83003, Ukraine
Unknown Facility
Donetsk, 83114, Ukraine
Unknown Facility
Kharkiv, 61178, Ukraine
Unknown Facility
Kiev, 02091, Ukraine
Unknown Facility
Kiev, 1151, Ukraine
Unknown Facility
Kiev, 2091, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2007
First Posted
April 17, 2007
Study Start
May 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
August 5, 2016
Record last verified: 2016-08