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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00461058
Recruitment Status : Completed
First Posted : April 17, 2007
Last Update Posted : August 5, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Actos Drug: aleglitazar Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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.
Study Start Date : May 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Actos Drug: Actos
Titrated to an individual maximum tolerated dose up to 45mg p.o. daily

Experimental: Aleglitazar Drug: aleglitazar
Titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily

Primary Outcome Measures :
  1. Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period. [ Time Frame: 26 week ]

Secondary Outcome Measures :
  1. Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period, adverse events (AEs), laboratory parameters. [ Time Frame: 26 week ]
  2. Efficacy: Change from baseline to week 26 in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), fasting plasma insulin (FPI) and lipid profile. [ Time Frame: 26 week ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;
  • HbA1c 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00461058

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United States, Arkansas
Jonesboro, Arkansas, United States, 72401
United States, California
Carmichael, California, United States, 95608
Loma Linda, California, United States, 92354
Long Beach, California, United States, 90822
United States, Florida
Jacksonville, Florida, United States, 32216
United States, Louisiana
Slidell, Louisiana, United States, 70458
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
Tulsa, Oklahoma, United States, 74104
Ashkelon, Israel, 78278
Haifa, Israel, 31096
Kfar Saba, Israel, 44281
Culiacan, Mexico, SIN80020
Guadalajara, Mexico, JAL44340
Metepec, Mexico, EMEX52140
Mexico City, Mexico, 11650
Mexico City, Mexico, DF7060
Monterrey, Mexico, 64000
Pachuca, Mexico, 42000
San Luis Potosi, Mexico, SLP78250
Arad, Romania, 310037
Bacau, Romania, 600114
Baia Mare, Romania, 430123
Bucuresti, Romania, 010242
Bucuresti, Romania, 20475
Bucuresti, Romania, 50452
Oradea, Romania, 410169
Ploiesti, Romania, 100097
Targoviste, Romania, 130083
Russian Federation
Moscow, Russian Federation, 123436
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 127018
Moscow, Russian Federation, 127299
Saratov, Russian Federation, 410028
St Petersburg, Russian Federation, 191025
St Petersburg, Russian Federation, 198205
St Petersburg, Russian Federation, 199106
Yaroslavl, Russian Federation, 150062
Donetsk, Ukraine, 83003
Donetsk, Ukraine, 83114
Kharkov, Ukraine, 61178
Kiev, Ukraine, 02091
Kiev, Ukraine, 1151
Kiev, Ukraine, 2091
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT00461058    
Other Study ID Numbers: BC20265
First Posted: April 17, 2007    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Heart Failure
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs