Clinical trial NCT00226330: GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus
Official title: A Double-Blind, Multi-Centre, Active-Controlled (15, 30, and 45 mg Pioglitazone) Long-Term Extension Study to Evaluate the Safety and Tolerability of Tesaglitazar (0.5 and 1 mg) in Patients With Type 2 Diabetes Mellitus (GALLEX 6)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 6.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-27
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.


Eligibility criteria: 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 the randomized treatment period in GALLANT 6

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, or neutropenia (low white blood cells)
* Creatinine levels of above twice the normal range
* Creatine kinase of above 3 times the upper limit of normal
* Previous enrollment in this long-term extension study
* Any clinically significant abnormality identified by 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

Primary outcomes:
measure: Adverse events
measure: Laboratory variables
measure: Physical examination
measure: Cardiac evaluation
measure: Hypoglycemic events
measure: Electrocardiogram
measure: Vital signs (blood pressure and pulse)
measure: Body weight
Secondary outcomes:
measure: Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
measure: Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
measure: Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C
measure: C-reactive protein (CRP)
measure: Central obesity (waist circumference, hip circumference, waist/hip ratio)
measure: Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Columbiana
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Chandler
country: United States
facility: Research Site
state: Arizona
city: Mesa
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Sierra Vista
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
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state: Arizona
city: Jonesboro
country: United States
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state: Arkansas
city: Little Rock
country: United States
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state: Arkansas
city: Searcy
country: United States
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state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Carmichael
country: United States
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state: California
city: Dinuba
country: United States
facility: Research Site
state: California
city: Elk Grove
country: United States
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state: California
city: Encinitas
country: United States
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state: California
city: Encino
country: United States
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state: California
city: Fresno
country: United States
facility: Research Site
state: California
city: Greenbrae
country: United States
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state: California
city: Loma Linda
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Mission Viejo
country: United States
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state: California
city: Northridge
country: United States
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state: California
city: Pasadena
country: United States
facility: Research Site
state: California
city: Redondo Beach
country: United States
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state: California
city: Riverside
country: United States
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state: California
city: Sacramento
country: United States
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state: California
city: Santa Ana
country: United States
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state: California
city: Santa Monica
country: United States
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state: California
city: Spring Valley
country: United States
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state: California
city: Tustin
country: United States
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state: California
city: Walnut Creek
country: United States
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state: California
city: West Hills
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state: California
city: Newark
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state: Delaware
city: Washington
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state: District of Columbia
city: Brandon
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state: Florida
city: Cooper City
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state: Florida
city: Delray Beach
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state: Florida
city: Gainesville
country: United States
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state: Florida
city: Hialeah
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state: Florida
city: Hollywood
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state: Florida
city: Jacksonville
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state: Florida
city: Melbourne
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city: Miami
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state: Florida
city: Ocoee
country: United States
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state: Florida
city: Orlando
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state: Florida
city: Plantation
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state: Florida
city: W. Palm Beach
country: United States
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state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Augusta
country: United States
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state: Georgia
city: Columbus
country: United States
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state: Georgia
city: Dunwoody
country: United States
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state: Georgia
city: Berwyn
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state: Illinois
city: Chicago
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city: Elk Grove Village
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city: Gurnee
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city: Melrose Park
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city: North Chicago
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city: Peoria
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city: Sterling
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state: Illinois
city: Indianapolis
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city: Des Moines
country: United States
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city: Waterloo
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state: Iowa
city: Topeka
country: United States
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city: Witchita
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city: Lexington
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state: Kentucky
city: Louisville
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city: New Orleans
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city: Slidell
country: United States
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city: Baltimore
country: United States
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state: Maryland
city: Columbia
country: United States
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state: Maryland
city: Haverhill
country: United States
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state: Massachusetts
city: Petoskey
country: United States
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state: Michigan
city: Excelsior Springs
country: United States
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state: Missouri
city: Richmond Heights
country: United States
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state: Missouri
city: Rolla
country: United States
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state: Missouri
city: Las Vegas
country: United States
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state: Nevada
city: North Las Vegas
country: United States
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state: Nevada
city: Pahrump
country: United States
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state: Nevada
city: Reno
country: United States
facility: Research Site
state: Nevada
city: Pleasantville
country: United States
facility: Research Site
state: New Jersey
city: Manlius
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Olean
country: United States
facility: Research Site
state: New York
city: Staten Island
country: United States
facility: Research Site
state: New York
city: Asheville
country: United States
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state: North Carolina
city: Winston-Salem
country: United States
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state: North Carolina
city: Cincinnati
country: United States
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state: Ohio
city: Lakewood
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city: Oklahoma City
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city: Medford
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city: Portland
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city: Altoona
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city: Erie
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city: Philadelphia
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city: Reading
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city: Columbia
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city: Memphis
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city: Carrollton
country: United States
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city: Dallas
country: United States
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state: Texas
city: North Richland Hills
country: United States
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city: San Antonio
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city: Salt Lake City
country: United States
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state: Utah
city: Norfolk
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state: Virginia
city: Virginia Beach
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state: Virginia
city: Gig Harbor
country: United States
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state: Washington
city: Huntington
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state: West Virginia
city: Moron
country: Argentina
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state: Buenos Aires
city: Quilmes
country: Argentina
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state: Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
city: Córdoba - Córdoba
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Salta - Salta
country: Argentina
facility: Research Site
city: Curitiba
country: Brazil
facility: Research Site
city: Fortaleza
country: Brazil
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city: Goiânia
country: Brazil
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city: Porto Alegre
country: Brazil
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city: Ribeirão Preto
country: Brazil
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city: São Paulo
country: Brazil
facility: Research Site
city: Edmonton
country: Canada
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state: Alberta
city: Abbotsford
country: Canada
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state: British Columbia
city: Chilliwack
country: Canada
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state: British Columbia
city: Vancouver
country: Canada
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state: British Columbia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: St. John's
country: Canada
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state: Newfoundland and Labrador
city: Dartmouth
country: Canada
facility: Research Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Truro
country: Canada
facility: Research Site
state: Nova Scotia
city: Windsor
country: Canada
facility: Research Site
state: Nova Scotia
city: Brampton
country: Canada
facility: Research Site
state: Ontario
city: Etobicoke
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Niagara Falls
country: Canada
facility: Research Site
state: Ontario
city: Oshawa
country: Canada
facility: Research Site
state: Ontario
city: Scarborough
country: Canada
facility: Research Site
state: Ontario
city: St. Catharines
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Research Site
state: Quebec
city: Longueuil
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Trois-Rivières
country: Canada
facility: Research Site
state: Quebec
city: Helsinki
country: Finland
facility: Research Site
city: Kauniainen
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Pietarsaari
country: Finland
facility: Research Site
city: Pori
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Guadalajara, Jalisco.
country: Mexico
facility: Research Site
city: México, D.F.
country: Mexico
facility: Research Site
city: Nuevo León, Monterrey
country: Mexico
facility: Research Site
city: Puebla, Mexico
country: Mexico
facility: Research Site
city: Torreon
country: Mexico
facility: Research Site
city: Zapopan
country: Mexico
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Co Antrim N Ireland
country: United Kingdom
facility: Research Site
city: Co. Wexford, Ireland
country: United Kingdom
facility: Research Site
city: Dublin
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Kent
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Mid Glamorgan
country: United Kingdom
facility: Research Site
city: Pembrokeshire
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
city: Surrey
country: United Kingdom
facility: Research Site
city: Wiltshire
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Galida Medical Science Director, MD
role: STUDY_DIRECTOR
References: