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NCT Number: NCT00461058

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

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ashkelon, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Actos

Drug

Titrated to an individual maximum tolerated dose up to 45mg p.o. daily

aleglitazar

Drug

Titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily

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.

    Time frame: 26 week

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 17, 2007
Registry last updated
Aug 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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