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

Type 2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00252876
• Other study ID #: D6160C00038
• Secondary ID: GALLEX 1
• Status: Terminated
• Phase: Phase 3
• First received: November 10, 2005
• Last updated: March 14, 2008
• Start date: March 2005
• Est. completion date: January 2007

Study information

• Verified date: March 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2000
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• tesaglitazar

Locations

Country	Name	City	State
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Córdoba
Argentina	Research Site	Moron	Buenos Aires
Argentina	Research Site	Quilmes	Buenos Aires
Argentina	Research Site	Rosario
Argentina	Research Site	Salta - Salta
Australia	Research Site	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
Brazil	Research Site	Curitiba
Brazil	Research Site	Fortaleza
Brazil	Research Site	Goiânia
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Ribeirão Preto
Brazil	Research Site	São Paulo
Canada	Research Site	Bay Roberts	Newfoundland and Labrador
Canada	Research Site	Bolton	Ontario
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Chomedey-Laval	Quebec
Canada	Research Site	Coquitlam	British Columbia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Hastings	Ontario
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Laval	Quebec
Canada	Research Site	London	Ontario
Canada	Research Site	Montréal	Quebec
Canada	Research Site	Mount Pearl	Newfoundland and Labrador
Canada	Research Site	Napanee	Ontario
Canada	Research Site	North York	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	Smith Falls	Ontario
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Surrey	British Columbia
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Winnipeg	Manitoba
Czech Republic	Research Site	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
Estonia	Research Site	Paide
Estonia	Research Site	Pärnu
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
Estonia	Research Site	Viljandi
Finland	Research Site	Hämeenlinna
Finland	Research Site	Helsinki
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
Former Serbia and Montenegro	Research Site	Belgrade
Greece	Research Site	Athens
Greece	Research Site	Piraeus
Hong Kong	Research Site	Hong Kong
Hungary	Research Site	Balatonfüred
Hungary	Research Site	Budapest
Hungary	Research Site	Gyor
Hungary	Research Site	Kaposvár
Hungary	Research Site	Kecskemét
Hungary	Research Site	Miskolc
Hungary	Research Site	Siófok
Hungary	Research Site	Székesfehérvár
India	Research Site	Bangalore
India	Research Site	Hyderabad
India	Research Site	Mumbai
India	Research Site	New Delhi
Indonesia	Research Site	Jakarta
Indonesia	Research Site	Malang
Israel	Research Site	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
Italy	Research Site	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
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon
Latvia	Research Site	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
Lithuania	Research Site	Vilnius
Malaysia	Research Site	Kuala Lumpur
Malaysia	Research Site	Kubang Kerian	Kota Bharu
Malaysia	Research Site	Penang
Netherlands	Research Site	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
Philippines	Research Site	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
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdansk
Poland	Research Site	Katowice	Ochojec
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
Portugal	Research Site	Almada
Portugal	Research Site	Amadora
Portugal	Research Site	Elvas
Portugal	Research Site	Lisbon
Portugal	Research Site	Portalegre
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	Yaroslavl
Singapore	Research Site	Singapore
Slovakia	Research Site	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
South Africa	Research Site	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
Switzerland	Research Site	Bern
Switzerland	Research Site	Ilanz
Switzerland	Research Site	Lausanne
Switzerland	Research Site	Monthey
Switzerland	Research Site	Zürich
United Kingdom	Research Site	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 States	Research Site	Albuquerque	New Mexico
United States	Research Site	Atlanta	Georgia
United States	Research Site	Baltimore	Maryland
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boise	Idaho
United States	Research Site	Bossier City	Louisiana
United States	Research Site	Bronx	New York
United States	Research Site	Brunswick	Georgia
United States	Research Site	Burke	Virginia
United States	Research Site	Carlisle	Arkansas
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chula Vista	California
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clearwater	Florida
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbiana	Alabama
United States	Research Site	Corpus Christi	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Escondido	California
United States	Research Site	Evansville	Indiana
United States	Research Site	Gainesville	Florida
United States	Research Site	Hamilton	New Jersey
United States	Research Site	Hollywood	Florida
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Huntington Beach	California
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kalamazoo	Michigan
United States	Research Site	Kettering	Ohio
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Los Angeles	California
United States	Research Site	Medford	Oregon
United States	Research Site	Menomonee Falls	Wisconsin
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Mission Viejo	California
United States	Research Site	Mobile	Alabama
United States	Research Site	Morristown	Tennessee
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	Norfolk	Virginia
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orange	California
United States	Research Site	Pahrump	Nevada
United States	Research Site	Pasadena	California
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Redondo Beach	California
United States	Research Site	Richmond	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Sacramento	California
United States	Research Site	San Antonio	Texas
United States	Research Site	Sherwood	Arkansas
United States	Research Site	Simpsonville	South Carolina
United States	Research Site	Tacoma	Washington
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Wheat Ridge	Colorado
United States	Research Site	White Plains	New York
United States	Research Site	Witchita	Kansas
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Brazil,  Canada,  Czech Republic,  Estonia,  Finland,  Former Serbia and Montenegro,  Greece,  Hong Kong,  Hungary,  India,  Indonesia,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Netherlands,  Philippines,  Poland,  Portugal,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
Secondary	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)
Secondary	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
Secondary	C-reactive protein
Secondary	Central obesity (waist circumference, hip circumference, waist/hip ratio)