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NCT00461058 · ClinicalTrials.gov registry record · Phase 2

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 of Diabetes Mellitus, Type 2, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
14
Enrollment target
20
Study locations

NCT00461058 is a Phase 2 study of Diabetes Mellitus, Type 2 that has completed, run by Hoffmann-La Roche. The registered enrollment target is 14 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT00461058, a Phase 2 study of Diabetes Mellitus, Type 2, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
14 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Diabetes Mellitus, Type 2

Interventions

  • DRUG Actos
  • DRUG aleglitazar

Study Locations (20)

Other

  • - Ashkelon
  • - Haifa
  • - Kfar Saba
  • - Culiacán
  • - Guadalajara
  • - Metepec
  • - Mexico City
  • - Mexico City
  • - Monterrey
  • - Pachuca

California

  • - Carmichael
  • - Loma Linda
  • - Long Beach

Oklahoma

  • - Oklahoma City
  • - Tulsa

Arkansas

  • - Jonesboro

Florida

  • - Jacksonville

Louisiana

  • - Slidell

Minnesota

  • - Minneapolis

Ohio

  • - Cleveland

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2007-05
Est. Completion 2007-12
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00461058

The ClinicalTrials.gov registry entry for NCT00461058 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (100% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Actos is the first listed.

NCT00461058 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, California, Oklahoma.

Frequently Asked Questions

What is clinical trial NCT00461058 about?

NCT00461058 is a clinical study titled "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 ...

What is the current status of trial NCT00461058?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2007-05. Estimated completion is 2007-12.

What conditions does trial NCT00461058 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.

What interventions are being tested in trial NCT00461058?

The interventions under investigation include: Actos (DRUG), aleglitazar (DRUG).

Who is sponsoring clinical trial NCT00461058?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00461058 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Louisiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.