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Diabetes Mellitus Type 2Phase 2NCT00461058

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 Phase 2 study testing Actos and aleglitazar in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 45 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
Actos and aleglitazar
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
45 sitesin 6 countries
Study dates
May 2007to Dec 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • type 1 diabetes;
  • current or previous treatment with insulin;
  • uncontrolled hypertension;
  • NYHA class 1, 3 or 4 at screening.

Trial locations and contacts

45 sites in 6 countries.

45 sites in 6 countries

United States10 sites

  • Study site

    Carmichael, California, 95608

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Loma Linda, California, 92354

  • Study site

    Long Beach, California, 90822

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Slidell, Louisiana, 70458

  • Study site

    Tulsa, Oklahoma, 74104

Other trials in United States

Romania9 sites

  • Study site

    Arad, 310037

  • Study site

    Bacau, 600114

  • Study site

    Baia Mare, 430123

  • Study site

    Bucharest, 010242

  • Study site

    Bucharest, 20475

  • Study site

    Bucharest, 50452

  • Study site

    Oradea, 410169

  • Study site

    Ploieşti, 100097

  • Study site

    Targoviste, 130083

Other trials in Romania

Russia9 sites

  • Study site

    Moscow, 123436

  • Study site

    Moscow, 125101

  • Study site

    Moscow, 127018

  • Study site

    Moscow, 127299

  • Study site

    Saint Petersburg, 191025

  • Study site

    Saint Petersburg, 198205

  • Study site

    Saint Petersburg, 199106

  • Study site

    Saratov, 410028

  • Study site

    Yaroslavl, 150062

Other trials in Russia

Mexico8 sites

  • Study site

    Culiacán, SIN80020

  • Study site

    Guadalajara, JAL44340

  • Study site

    Metepec, EMEX52140

  • Study site

    Mexico City, 11650

  • Study site

    Mexico City, DF7060

  • Study site

    Monterrey, 64000

  • Study site

    Pachuca, 42000

  • Study site

    San Luis Potosí City, SLP78250

Other trials in Mexico

Ukraine6 sites

  • Study site

    Donetsk, 83003

  • Study site

    Donetsk, 83114

  • Study site

    Kharkiv, 61178

  • Study site

    Kiev, 02091

  • Study site

    Kiev, 1151

  • Study site

    Kiev, 2091

Other trials in Ukraine

Israel3 sites

  • Study site

    Ashkelon, 78278

  • Study site

    Haifa, 31096

  • Study site

    Kfar Saba, 44281

Other trials in Israel

About this study

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.

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.

Being tested
Actos, aleglitazar
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ActosDrug

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

  • aleglitazarDrug

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

Study groups in NCT00461058
Study groupRoleWhat they receive
ActosActive comparatorNot described
Receives: Drug: Actos
AleglitazarExperimentalNot described
Receives: Drug: aleglitazar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period.

    Measured: 26 week

Secondary outcomes (2)

  1. Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period, adverse events (AEs), laboratory parameters.

    Measured: 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.

    Measured: 26 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00461058
Sponsor's protocol ID
BC20265
Status last verified
Aug 2016
First submitted
16 Apr 2007
Last updated
5 Aug 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Actos and aleglitazar in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 45 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Romania, Russia, Mexico, Ukraine and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00461058.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016.

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