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

August 3, 2016 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ashkelon, Israel, 78278
      • Haifa, Israel, 31096
      • Kfar Saba, Israel, 44281
  • Mexico
      • 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
  • Romania
      • 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, 125101
      • Moscow, Russian Federation, 127299
      • Moscow, Russian Federation, 127018
      • Moscow, Russian Federation, 123436
      • Saratov, Russian Federation, 410028
      • St Petersburg, Russian Federation, 191025
      • St Petersburg, Russian Federation, 198205
      • St Petersburg, Russian Federation, 199106
      • Yaroslavl, Russian Federation, 150062
  • Ukraine
      • Donetsk, Ukraine, 83003
      • Donetsk, Ukraine, 83114
      • Kharkov, Ukraine, 61178
      • Kiev, Ukraine, 02091
      • Kiev, Ukraine, 2091
      • Kiev, Ukraine, 1151
  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
    • California
      • Carmichael, California, United States, 95608
      • Loma Linda, California, United States, 92354
      • Long Beach, California, United States, 90822
    • Florida
      • Jacksonville, Florida, United States, 32216
    • Louisiana
      • Slidell, Louisiana, United States, 70458
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • Ohio
      • Cleveland, Ohio, United States, 44195
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
      • Tulsa, Oklahoma, United States, 74104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aleglitazar
Drug: aleglitazar
Titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily
Active Comparator: Actos
Drug: Actos
Titrated to an individual maximum tolerated dose up to 45mg p.o. daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
26 week

Secondary Outcome Measures

Outcome Measure
Time Frame
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
26 week
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
26 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

April 16, 2007

First Submitted That Met QC Criteria

April 16, 2007

First Posted (Estimate)

April 17, 2007

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC20265

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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