GALLEX 1 - Long Term Extension Study in Patients With Type 2 Diabetes

March 14, 2008 updated by: AstraZeneca

An Open-Label, Multi-Centre and Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar 1 mg in Patients With Type 2 Diabetes Mellitus.

This is a 107-week open-label, multi-center long-term extension study from GALLANT studies 2/22, 5, 7, 8 and 14 to monitor the safety and tolerability of oral tesaglitazar 1 mg in patients with type 2 diabetes during up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

2000

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

  • Argentina
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Córdoba, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
      • Salta - Salta, Argentina
        • Research Site
    • Buenos Aires
      • Moron, Buenos Aires, Argentina
        • Research Site
      • Quilmes, Buenos Aires, Argentina
        • Research Site
  • Australia
      • Adelaide, Australia
        • Research Site
      • Brisbane, Australia
        • Research Site
      • Cairns, Australia
        • Research Site
      • Geelong, Australia
        • Research Site
      • Melbourne, Australia
        • Research Site
      • Perth, Australia
        • Research Site
      • Sydney, Australia
        • Research Site
      • Tasmania, Australia
        • Research Site
  • Brazil
      • Curitiba, Brazil
        • Research Site
      • Fortaleza, Brazil
        • Research Site
      • Goiânia, Brazil
        • Research Site
      • Porto Alegre, Brazil
        • Research Site
      • Ribeirão Preto, Brazil
        • Research Site
      • São Paulo, Brazil
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
    • British Columbia
      • Coquitlam, British Columbia, Canada
        • Research Site
      • Surrey, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada
        • Research Site
      • Mount Pearl, Newfoundland and Labrador, Canada
        • Research Site
      • St. John's, Newfoundland and Labrador, Canada
        • Research Site
    • Ontario
      • Bolton, Ontario, Canada
        • Research Site
      • Brampton, Ontario, Canada
        • Research Site
      • Hamilton, Ontario, Canada
        • Research Site
      • Hastings, Ontario, Canada
        • Research Site
      • Kingston, Ontario, Canada
        • Research Site
      • London, Ontario, Canada
        • Research Site
      • Napanee, Ontario, Canada
        • Research Site
      • North York, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Smith Falls, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Chomedey-Laval, Quebec, Canada
        • Research Site
      • Laval, Quebec, Canada
        • Research Site
      • Montréal, Quebec, Canada
        • Research Site
      • Sherbrooke, Quebec, Canada
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Hodonin, Czech Republic
        • Research Site
      • Hradec Kralove, Czech Republic
        • Research Site
      • Plzen, Czech Republic
        • Research Site
      • Praha 5, Czech Republic
        • Research Site
      • Pribram, Czech Republic
        • Research Site
      • Semily, Czech Republic
        • Research Site
      • Tabor, Czech Republic
        • Research Site
      • Usti nad Labem, Czech Republic
        • Research Site
  • Estonia
      • Paide, Estonia
        • Research Site
      • Pärnu, Estonia
        • Research Site
      • Tallinn, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
      • Viljandi, Estonia
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Hämeenlinna, Finland
        • Research Site
      • Imatra, Finland
        • Research Site
      • Joensuu, Finland
        • Research Site
      • Kokkola, Finland
        • Research Site
      • Kouvola, Finland
        • Research Site
      • Kuopio, Finland
        • Research Site
      • Lahti, Finland
        • Research Site
      • Mikkeli, Finland
        • Research Site
      • Oulu, Finland
        • Research Site
      • Pietarsaari, Finland
        • Research Site
      • Salo, Finland
        • Research Site
      • Seinajoki, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
      • Turku, Finland
        • Research Site
      • Vaasa, Finland
        • Research Site
      • Vantaa, Finland
        • Research Site
  • Former Serbia and Montenegro
      • Belgrade, Former Serbia and Montenegro
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Piraeus, Greece
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
  • Hungary
      • Balatonfüred, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Győr, Hungary
        • Research Site
      • Kaposvár, Hungary
        • Research Site
      • Kecskemét, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
      • Siófok, Hungary
        • Research Site
      • Székesfehérvár, Hungary
        • Research Site
  • India
      • Bangalore, India
        • Research Site
      • Hyderabad, India
        • Research Site
      • Mumbai, India
        • Research Site
      • New Delhi, India
        • Research Site
  • Indonesia
      • Jakarta, Indonesia
        • Research Site
      • Malang, Indonesia
        • 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
      • Tel Hashomer, Israel
        • Research Site
      • Zefat, Israel
        • Research Site
  • Italy
      • Arenzano, Italy
        • Research Site
      • Chiavari (GE), Italy
        • Research Site
      • Chieri, Italy
        • Research Site
      • Firenze, Italy
        • Research Site
      • Messina, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Monteccio Emilia, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Padova, Italy
        • Research Site
      • Pescara, Italy
        • Research Site
      • Piacenza, Italy
        • Research Site
      • Pistoia, Italy
        • Research Site
      • Reggio Calabria, Italy
        • Research Site
      • Reggio Emilia, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Scandiano, Italy
        • Research Site
      • Udine, Italy
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Research Site
      • Suwon, Korea, Republic of
        • Research Site
  • Latvia
      • Daugavpils, Latvia
        • Research Site
      • Jekabpils, Latvia
        • Research Site
      • Madona, Latvia
        • Research Site
      • Riga, Latvia
        • Research Site
      • SIgulda, Latvia
        • Research Site
      • Talsi, Latvia
        • Research Site
      • Valmiera, Latvia
        • Research Site
  • Lithuania
      • Vilnius, Lithuania
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Research Site
      • Penang, Malaysia
        • Research Site
    • Kota Bharu
      • Kubang Kerian, Kota Bharu, Malaysia
        • Research Site
  • Netherlands
      • Beek en Donk, Netherlands
        • Research Site
      • Bennebroek, 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
  • Philippines
      • Cebu City, Philippines
        • Research Site
      • Makati, Philippines
        • Research Site
      • Manila, Philippines
        • Research Site
      • Marikina City, Philippines
        • Research Site
      • Pasig City, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Olsztyn, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Radom, Poland
        • Research Site
      • Rzeszow, Poland
        • Research Site
      • Sopot, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Toruñ, Poland
        • Research Site
      • Tychy, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
      • Zielona Gora, Poland
        • Research Site
    • Ochojec
      • Katowice, Ochojec, Poland
        • Research Site
  • Portugal
      • Almada, Portugal
        • Research Site
      • Amadora, Portugal
        • Research Site
      • Elvas, Portugal
        • Research Site
      • Lisbon, Portugal
        • Research Site
      • Portalegre, Portugal
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
      • Yaroslavl, Russian Federation
        • Research Site
  • Singapore
      • Singapore, Singapore
        • Research Site
  • Slovakia
      • Dolny Kubin, Slovakia
        • Research Site
      • Levice, Slovakia
        • Research Site
      • Lubochna, Slovakia
        • Research Site
      • Lucenec, Slovakia
        • Research Site
      • Nove Zamky, Slovakia
        • Research Site
      • Povazska Bystrica, Slovakia
        • Research Site
      • Sahy, Slovakia
        • Research Site
      • Trencin, Slovakia
        • Research Site
      • Velky Meder, Slovakia
        • Research Site
      • Zilina, Slovakia
        • Research Site
  • South Africa
      • Cape Town, South Africa
        • Research Site
      • Chatsworth, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Gauteng, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
  • Switzerland
      • Bern, Switzerland
        • Research Site
      • Ilanz, Switzerland
        • Research Site
      • Lausanne, Switzerland
        • Research Site
      • Monthey, Switzerland
        • Research Site
      • Zürich, Switzerland
        • Research Site
  • United Kingdom
      • Aberdeen, United Kingdom
        • Research Site
      • Atherstone, United Kingdom
        • Research Site
      • Ayr, United Kingdom
        • Research Site
      • Bath, United Kingdom
        • Research Site
      • Belfast, United Kingdom
        • Research Site
      • Berks, United Kingdom
        • Research Site
      • Birmingham, United Kingdom
        • Research Site
      • Bolton, United Kingdom
        • Research Site
      • Bucks, United Kingdom
        • Research Site
      • Cardiff, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Dundee, United Kingdom
        • Research Site
      • Edinburgh, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Leeds, United Kingdom
        • Research Site
      • Liverpool, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Northampton, United Kingdom
        • Research Site
      • Plymouth, United Kingdom
        • Research Site
      • Radstock, United Kingdom
        • Research Site
      • Shrewsbury, United Kingdom
        • Research Site
      • Surrey, United Kingdom
        • Research Site
      • West Bromwich, United Kingdom
        • Research Site
      • Wiltshire, United Kingdom
        • Research Site
      • Wrexham, 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
    • Arkansas
      • Carlisle, Arkansas, United States
        • Research Site
      • Sherwood, Arkansas, United States
        • Research Site
    • 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
      • 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
    • Hawaii
      • Honolulu, Hawaii, United States
        • Research Site
    • Idaho
      • Boise, Idaho, United States
        • Research Site
    • Indiana
      • Evansville, Indiana, United States
        • Research Site
    • Kansas
      • 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
    • Michigan
      • Kalamazoo, Michigan, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
      • Pahrump, 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
      • Bronx, New York, United States
        • Research Site
      • New York, 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
      • 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
  • Vietnam
      • Hanoi, Vietnam
        • Research Site
      • Ho Chi Minh, Vietnam
        • 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 >=18 years of age
  • Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
  • Completed the last two visits of randomized treatment period in GALLANT 2/22, 5, 7, 8 or 14 studies.

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
  • Previous enrollment in this long-term extension study
  • 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight

Secondary Outcome Measures

Outcome Measure
C-reactive protein
Central obesity (waist circumference, hip circumference, waist/hip ratio)
Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c, lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol)
Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol

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

March 1, 2005

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

November 10, 2005

First Submitted That Met QC Criteria

November 10, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Estimate)

March 17, 2008

Last Update Submitted That Met QC Criteria

March 14, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6160C00038
  • GALLEX 1

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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