GALLANT 5 Tesaglitazar Versus Metformin

November 18, 2010 updated by: AstraZeneca

A 52-wk Randomised, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin) Study to Evaluate the Efficacy, Safety & Tolerability of Tesaglitazar Therapy When Administered to Patients With Type 2 Diabetes

This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (metformin) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week placebo single blind run in period followed by a 52-week a double blind treatment period and a 3-week follow-up period. Tesaglitazar and metformin will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
580

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

  • Finland
      • Helsinki, Finland
        • Research Site
      • Hämeenlinna, Finland
        • Research Site
      • Joensuu, Finland
        • Research Site
      • Kouvola, Finland
        • Research Site
      • Kuopio, Finland
        • Research Site
      • Mikkeli, Finland
        • Research Site
      • Oulu, Finland
        • Research Site
      • Salo, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
      • Vantaa, Finland
        • Research Site
  • Germany
      • Aschaffenburg, Germany
        • Research Site
      • Bad Segeberg, Germany
        • Research Site
      • Beckum, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Ehrenberg, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Feldafing, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Hermaringen, Germany
        • Research Site
      • Künzing, Germany
        • Research Site
      • Langen, Germany
        • Research Site
      • Mannheim, Germany
        • Research Site
      • Marl, Germany
        • Research Site
      • Nürnberg, Germany
        • Research Site
      • Pirna, Germany
        • Research Site
      • Rotenburg/Fulda, Germany
        • Research Site
  • Israel
      • Ashkelon, Israel
        • Research Site
      • Haifa, Israel
        • Research Site
      • Holon, Israel
        • Research Site
      • Jerusalem, Israel
        • Research Site
      • Rishon-Lezion, Israel
        • Research Site
      • Tel Aviv, Israel
        • Research Site
      • Zefat, Israel
        • Research Site
  • Netherlands
      • Beek en Donk, Netherlands
        • Research Site
      • Bennebroe, Netherlands
        • Research Site
      • Den Haag, Netherlands
        • Research Site
      • Deurne, Netherlands
        • Research Site
      • Huizen, Netherlands
        • Research Site
      • Losser, Netherlands
        • Research Site
      • Nijverdal, Netherlands
        • Research Site
      • Rijswijk, Netherlands
        • Research Site
      • Roelofarendsveen, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
  • Norway
      • Bergen, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Østerås, Norway
        • Research Site
  • Spain
      • Alzira (Valencia), Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Begonte (Lugo), Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
    • Alicante
      • San Vicente de Raspeig, Alicante, Spain
        • Research Site
    • Valencia
      • Villar del Arzobispo, Valencia, Spain
        • Research Site
  • United Kingdom
      • Aberdeen, United Kingdom
        • Research Site
      • Ayr, United Kingdom
        • Research Site
      • Bath, United Kingdom
        • Research Site
      • Berks, United Kingdom
        • Research Site
      • Bucks, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Dundee, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Northampton, United Kingdom
        • Research Sites
      • Wiltshire, United Kingdom
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
      • Columbiana, Alabama, United States
        • Research Site
      • Mobile, Alabama, United States
        • Research Site
    • Arizona
      • Carlisle, Arizona, United States
        • Research Site
      • Sherwood, Arizona, United States
        • Research Center
    • California
      • Chula Vista, California, United States
        • Research Site
      • Escondido, California, United States
        • Research Site
      • Huntington Beach, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Mission Viejo, California, United States
        • Research Site
      • Orange, California, United States
        • Research Site
      • Pasadena, California, United States
        • Research Site
      • Pomona, California, United States
        • Research Site
      • Redondo Beach, California, United States
        • Research Site
      • Sacramento, California, United States
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • Research Site
      • Wheat Ridge, Colorado, United States
        • Research Site
    • Florida
      • Clearwater, Florida, United States
        • Research Site
      • Gainesville, Florida, United States
        • Research Site
      • Hollywood, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Brunswick, Georgia, United States
        • Research Site
      • Carollton, Georgia, United States
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States
        • Research Site
    • Idaho
      • Boise, Idaho, United States
        • Research Site
    • Indiana
      • Evansville, Indiana, United States
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States
        • Research Site
      • Overland Park, Kansas, United States
        • Research Site
      • Witchita, Kansas, United States
        • Research Site
    • Louisiana
      • Bossier City, Louisiana, United States
        • Research Site
      • New Orleans, Louisiana, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • Missouri
      • Kalamazoo, Missouri, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • New Jersey
      • Hamilton, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • Albany, New York, United States
        • Research Site
      • Bronx, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
      • Pahrump, New York, United States
        • Research Site
      • Rochester, New York, United States
        • Research Site
      • White Plains, New York, United States
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Dayton, Ohio, United States
        • Research Site
      • Kettering, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Medford, Oregon, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Simpsonville, South Carolina, United States
        • Research Site
    • Tennessee
      • Morristown, Tennessee, United States
        • Research Site
    • Texas
      • Corpus Christi, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Lubbock, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Virginia
      • Burke, Virginia, United States
        • Research Site
      • Norfolk, Virginia, United States
        • Research Site
      • Richmond, Virginia, United States
        • Research Site
    • Washington
      • Tacoma, Washington, United States
        • Research Site
    • Wisconsin
      • Menomonee Falls, Wisconsin, United States
        • Research Site
      • Milwaukee, Wisconsin, United States
        • Research Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of a written informed consent
  • Men or women who are ³18 years of age
  • Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
  • Diagnosed with type 2 diabetes
  • Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

Exclusion Criteria:

  • Type 1 diabetes
  • New York Heart Association heart failure Class III or IV
  • Treatment with chronic insulin
  • History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
  • History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
  • Creatinine levels above twice the normal range
  • Creatine kinase above 3 times the upper limit of normal
  • Received any investigational product in other clinical studies within 12 weeks
  • Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study

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 Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
Lipid parameters (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids, lipoprotein particle size and co
C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Fibrinogen
Urinary albumin excretion
Waist/hip ratio
Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
Pharmacokinetics of tesaglitazar
Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D6160C00029

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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