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

A Phase 3 study testing tesaglitazar in people with Type 2 Diabetes, run by AstraZeneca at 277 sites in 31 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: tesaglitazar
How many people: 2,000 participants
Where: 277 sitesin 31 countries
Study dates: Mar 2005to Jan 2007
Phase: Phase 3

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

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.

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

277 sites in 31 countries.

Country

City, postcode or hospital

277 sites in 31 countries

United States58 sites

Research Site
Albuquerque, New Mexico
Research Site
Atlanta, Georgia
Research Site
Baltimore, Maryland
Research Site
Birmingham, Alabama
Research Site
Boise, Idaho
Research Site
Bossier City, Louisiana
Research Site
Brunswick, Georgia
Research Site
Burke, Virginia
Research Site
Carlisle, Arkansas
Research Site
Charlotte, North Carolina
Research Site
Chula Vista, California
Research Site
Cincinnati, Ohio
Research Site
Clearwater, Florida
Research Site
Colorado Springs, Colorado
Research Site
Columbiana, Alabama
Research Site
Corpus Christi, Texas
Research Site
Dallas, Texas
Research Site
Dayton, Ohio
Research Site
Escondido, California
Research Site
Evansville, Indiana
Research Site
Gainesville, Florida
Research Site
Hamilton, New Jersey
Research Site
Hollywood, Florida
Research Site
Honolulu, Hawaii
Research Site
Huntington Beach, California
Research Site
Jacksonville, Florida
Research Site
Kalamazoo, Michigan
Research Site
Kettering, Ohio
Research Site
Las Vegas, Nevada
Research Site
Los Angeles, California
Research Site
Medford, Oregon
Research Site
Menomonee Falls, Wisconsin
Research Site
Miami, Florida
Research Site
Milwaukee, Wisconsin
Research Site
Mission Viejo, California
Research Site
Mobile, Alabama
Research Site
Morristown, Tennessee
Research Site
New Orleans, Louisiana
Research Site
New York, New York
Research Site
Norfolk, Virginia
Research Site
Oklahoma City, Oklahoma
Research Site
Orange, California
Research Site
Pahrump, Nevada
Research Site
Pasadena, California
Research Site
Philadelphia, Pennsylvania
Research Site
Redondo Beach, California
Research Site
Richmond, Virginia
Research Site
Rochester, New York
Research Site
Sacramento, California
Research Site
San Antonio, Texas
Research Site
Sherwood, Arkansas
Research Site
Simpsonville, South Carolina
Research Site
Tacoma, Washington
Research Site
The Bronx, New York
Research Site
West Palm Beach, Florida
Research Site
Wheat Ridge, Colorado
Research Site
White Plains, New York
Research Site
Witchita, Kansas

Other trials in United States

United Kingdom25 sites

Research Site
Aberdeen
Research Site
Atherstone
Research Site
Ayr
Research Site
Bath
Research Site
Belfast
Research Site
Berks
Research Site
Birmingham
Research Site
Bolton
Research Site
Bucks
Research Site
Cardiff
Research Site
Coventry
Research Site
Dundee
Research Site
Edinburgh
Research Site
Glasgow
Research Site
Leeds
Research Site
Liverpool
Research Site
Manchester
Research Site
Northampton
Research Site
Plymouth
Research Site
Radstock
Research Site
Shrewsbury
Research Site
Surrey
Research Site
West Bromwich
Research Site
Wiltshire
Research Site
Wrexham

Other trials in United Kingdom

Canada22 sites

Research Site
Bay Roberts, Newfoundland and Labrador
Research Site
Bolton, Ontario
Research Site
Brampton, Ontario
Research Site
Calgary, Alberta
Research Site
Chomedey-Laval, Quebec
Research Site
Coquitlam, British Columbia
Research Site
Hamilton, Ontario
Research Site
Hastings, Ontario
Research Site
Kingston, Ontario
Research Site
Laval, Quebec
Research Site
London, Ontario
Research Site
Montreal, Quebec
Research Site
Mount Pearl, Newfoundland and Labrador
Research Site
Napanee, Ontario
Research Site
North York, Ontario
Research Site
Ottawa, Ontario
Research Site
Sherbrooke, Quebec
Research Site
Smith Falls, Ontario
Research Site
St. John's, Newfoundland and Labrador
Research Site
Surrey, British Columbia
Research Site
Toronto, Ontario
Research Site
Winnipeg, Manitoba

Other trials in Canada

Finland17 sites

Research Site
Hämeenlinna
Research Site
Helsinki
Research Site
Imatra
Research Site
Jakobstad
Research Site
Joensuu
Research Site
Kokkola
Research Site
Kouvola
Research Site
Kuopio
Research Site
Lahti
Research Site
Mikkeli
Research Site
Oulu
Research Site
Salo
Research Site
Seinäjoki
Research Site
Tampere
Research Site
Turku
Research Site
Vaasa
Research Site
Vantaa

Other trials in Finland

Italy17 sites

Research Site
Arenzano
Research Site
Chiavari (GE)
Research Site
Chieri
Research Site
Florence
Research Site
Messina
Research Site
Milan
Research Site
Monteccio Emilia
Research Site
Naples
Research Site
Padova
Research Site
Pescara
Research Site
Piacenza
Research Site
Pistoia
Research Site
Reggio Calabria
Research Site
Reggio Emilia
Research Site
Roma
Research Site
Scandiano
Research Site
Udine

Other trials in Italy

Poland17 sites

Research Site
Bialystok
Research Site
Bydgoszcz
Research Site
Gdansk
Research Site
Katowice, Ochojec
Research Site
Krakow
Research Site
Lodz
Research Site
Olsztyn
Research Site
Poznan
Research Site
Radom
Research Site
Rzeszów
Research Site
Sopot
Research Site
Szczecin
Research Site
Toruñ
Research Site
Tychy
Research Site
Warsaw
Research Site
Wroclaw
Research Site
Zielona Góra

Other trials in Poland

Netherlands10 sites

Research Site
Beek en Donk
Research Site
Bennebroek
Research Site
Deurne
Research Site
Huizen
Research Site
Losser
Research Site
Nijverdal
Research Site
Rijswijk
Research Site
Roelofarendsveen
Research Site
Rotterdam
Research Site
The Hague

Other trials in Netherlands

Slovakia10 sites

Research Site
Dolný Kubín
Research Site
Levice
Research Site
Ľubochňa
Research Site
Lučenec
Research Site
Nové Zámky
Research Site
Považská Bystrica
Research Site
Šahy
Research Site
Trenčín
Research Site
Veľký Meder
Research Site
Žilina

Other trials in Slovakia

Czechia9 sites

Research Site
Brno
Research Site
Hodonín
Research Site
Hradec Králové
Research Site
Pilsen
Research Site
Prague
Research Site
Příbram
Research Site
Semily
Research Site
Tábor
Research Site
Ústí nad Labem

Other trials in Czechia

Australia8 sites

Research Site
Adelaide
Research Site
Brisbane
Research Site
Cairns
Research Site
Geelong
Research Site
Melbourne
Research Site
Perth
Research Site
Sydney
Research Site
Tasmania

Other trials in Australia

Hungary8 sites

Research Site
Balatonfüred
Research Site
Budapest
Research Site
Győr
Research Site
Kaposvár
Research Site
Kecskemét
Research Site
Miskolc
Research Site
Siófok
Research Site
Székesfehérvár

Other trials in Hungary

Israel8 sites

Research Site
Ashkelon
Research Site
Haifa
Research Site
Holon
Research Site
Jerusalem
Research Site
Rishon LeZiyyon
Research Site
Safed
Research Site
Tel Aviv
Research Site
Tel Litwinsky

Other trials in Israel

Latvia7 sites

Research Site
Daugavpils
Research Site
Jēkabpils
Research Site
Madona
Research Site
Riga
Research Site
Sigulda
Research Site
Talsi
Research Site
Valmiera

Other trials in Latvia

Argentina6 sites

Research Site
Ciudad de Buenos Aires
Research Site
Córdoba, Córdoba Province
Research Site
Morón, Buenos Aires
Research Site
Quilmes, Buenos Aires
Research Site
Rosario
Research Site
Salta - Salta

Other trials in Argentina

Brazil6 sites

Research Site
Curitiba
Research Site
Fortaleza
Research Site
Goiânia
Research Site
Porto Alegre
Research Site
Ribeirão Preto
Research Site
São Paulo

Other trials in Brazil

Philippines6 sites

Research Site
Cebu City
Research Site
Makati
Research Site
Manila
Research Site
Marikina City
Research Site
Pasig
Research Site
Quezon City

Other trials in Philippines

South Africa6 sites

Research Site
Cape Town
Research Site
Chatsworth
Research Site
Durban
Research Site
Gauteng
Research Site
Johannesburg
Research Site
Pretoria

Other trials in South Africa

Estonia5 sites

Research Site
Paide
Research Site
Pärnu
Research Site
Tallinn
Research Site
Tartu
Research Site
Viljandi

Other trials in Estonia

Portugal5 sites

Research Site
Almada
Research Site
Amadora
Research Site
Elvas
Research Site
Lisbon
Research Site
Portalegre

Other trials in Portugal

Switzerland5 sites

Research Site
Bern
Research Site
Ilanz
Research Site
Lausanne
Research Site
Monthey
Research Site
Zurich

Other trials in Switzerland

India4 sites

Research Site
Bangalore
Research Site
Hyderabad
Research Site
Mumbai
Research Site
New Delhi

Other trials in India

Malaysia3 sites

Research Site
George Town
Research Site
Kuala Lumpur
Research Site
Kubang Kerian, Kota Bharu

Other trials in Malaysia

Russia3 sites

Research Site
Moscow
Research Site
Saint Petersburg
Research Site
Yaroslavl

Other trials in Russia

Greece2 sites

Research Site
Athens
Research Site
Piraeus

Other trials in Greece

Indonesia2 sites

Research Site
Jakarta
Research Site
Malang

Other trials in Indonesia

South Korea2 sites

Research Site
Seoul
Research Site
Suwon

Other trials in South Korea

Vietnam2 sites

Research Site
Hanoi
Research Site
Ho Chi Minh City

Other trials in Vietnam

Hong Kong1 site

Research Site
Hong Kong

Other trials in Hong Kong

Lithuania1 site

Research Site
Vilnius

Other trials in Lithuania

Serbia and Montenegro1 site

Research Site
Belgrade

Other trials in Serbia and Montenegro

Singapore1 site

Research Site
Singapore

Other trials in Singapore

About this study

Official title: 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.

Conditions: Type 2 Diabetes
Being tested: tesaglitazar
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.

tesaglitazarDrug

What is being measured

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

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

Secondary outcomes (4)

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
C-reactive protein
Central obesity (waist circumference, hip circumference, waist/hip ratio)

Timeline

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

Mar 2005Jan 2007

First posted15 Nov 2005 (estimated)
Study startMar 2005
Study completionJan 2007

Why it stopped: The development program has been terminated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,000 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00252876
Sponsor's protocol ID: D6160C00038
Other IDs: GALLEX 1
Status last verified: Mar 2008
First submitted: 10 Nov 2005
Last updated: 17 Mar 2008
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Diabetes Toolkit at Discharge
Diabetes Mellitus, Type 2, Insulin Dependent Diabetes
Recruiting
Air Pollution and Cardiovascular Disease in Qatar: an Interventional Study to Reduce Blood Pressure
Hypertension, Systolic, Metabolic Syndrome
Active, not recruitingPhase 1/2
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Overweight and Obesity
Not yet recruiting
Remotely Delivered Mindfulness-Based Diabetes Education
Type 2 Diabetes
Recruiting
Flaxseed Consumption on Biochemical and Quality of Life in Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)

All Type 2 Diabetes trials