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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

580

Phase

  • 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

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

Outcome Measure
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)

Secondary Outcome Measures

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

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

August 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

November 19, 2010

Last Update Submitted That Met QC Criteria

November 18, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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