GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00226330
• Other study ID #: D6160C00048
• Status: Terminated
• Phase: Phase 3
• First received: September 23, 2005
• Last updated: November 18, 2010
• Start date: March 2005
• Est. completion date: December 2006

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1100
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• 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 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Tesaglitazar
(0.5 or 1 mg)
• Pioglitazone
(15, 30 or 45 mg)

Locations

Country	Name	City	State
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Córdoba - Córdoba
Argentina	Research Site	Moron	Buenos Aires
Argentina	Research Site	Quilmes	Buenos Aires
Argentina	Research Site	Rosario
Argentina	Research Site	Salta - Salta
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	Abbotsford	British Columbia
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Chicoutimi	Quebec
Canada	Research Site	Chilliwack	British Columbia
Canada	Research Site	Dartmouth	Nova Scotia
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Etobicoke	Ontario
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Longueuil	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Niagara Falls	Ontario
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	St. Catharines	Ontario
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Trois-Rivières	Quebec
Canada	Research Site	Truro	Nova Scotia
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Victoria	British Columbia
Canada	Research Site	Windsor	Nova Scotia
Finland	Research Site	Helsinki
Finland	Research Site	Kauniainen
Finland	Research Site	Kuopio
Finland	Research Site	Pietarsaari
Finland	Research Site	Pori
Finland	Research Site	Tampere
Mexico	Research Site	Guadalajara, Jalisco.
Mexico	Research Site	México, D.F.
Mexico	Research Site	Nuevo León, Monterrey
Mexico	Research Site	Puebla, Mexico
Mexico	Research Site	Torreon
Mexico	Research Site	Zapopan
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Co Antrim N Ireland
United Kingdom	Research Site	Co. Wexford, Ireland
United Kingdom	Research Site	Dublin
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Kent
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	Mid Glamorgan
United Kingdom	Research Site	Pembrokeshire
United Kingdom	Research Site	Plymouth
United Kingdom	Research Site	Reading
United Kingdom	Research Site	Surrey
United Kingdom	Research Site	Wiltshire
United States	Research Site	Altoona	Pennsylvania
United States	Research Site	Anaheim	California
United States	Research Site	Asheville	North Carolina
United States	Research Site	Atlanta	Georgia
United States	Research Site	Augusta	Georgia
United States	Research Site	Baltimore	Maryland
United States	Research Site	Berwyn	Illinois
United States	Research Site	Birmingham	Alabama
United States	Research Site	Brandon	Florida
United States	Research Site	Carmichael	California
United States	Research Site	Carrollton	Texas
United States	Research Site	Chandler	Arizona
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Columbia	South Carolina
United States	Research Site	Columbia	Maryland
United States	Research Site	Columbiana	Alabama
United States	Research Site	Columbus	Georgia
United States	Research Site	Cooper City	Florida
United States	Research Site	Dallas	Texas
United States	Research Site	Delray Beach	Florida
United States	Research Site	Des Moines	Iowa
United States	Research Site	Dinuba	California
United States	Research Site	Dunwoody	Georgia
United States	Research Site	Elk Grove	California
United States	Research Site	Elk Grove Village	Illinois
United States	Research Site	Encinitas	California
United States	Research Site	Encino	California
United States	Research Site	Erie	Pennsylvania
United States	Research Site	Excelsior Springs	Missouri
United States	Research Site	Fresno	California
United States	Research Site	Gainesville	Florida
United States	Research Site	Gig Harbor	Washington
United States	Research Site	Greenbrae	California
United States	Research Site	Gurnee	Illinois
United States	Research Site	Haverhill	Massachusetts
United States	Research Site	Hialeah	Florida
United States	Research Site	Hollywood	Florida
United States	Research Site	Huntington	West Virginia
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jonesboro	Arkansas
United States	Research Site	Lakewood	Ohio
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lexington	Kentucky
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Loma Linda	California
United States	Research Site	Long Beach	California
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Manlius	New York
United States	Research Site	Medford	Oregon
United States	Research Site	Melbourne	Florida
United States	Research Site	Melrose Park	Illinois
United States	Research Site	Memphis	Tennessee
United States	Research Site	Mesa	Arizona
United States	Research Site	Miami	Florida
United States	Research Site	Mission Viejo	California
United States	Research Site	Mobile	Alabama
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	Newark	Delaware
United States	Research Site	Norfolk	Virginia
United States	Research Site	North Chicago	Illinois
United States	Research Site	North Las Vegas	Nevada
United States	Research Site	North Richland Hills	Texas
United States	Research Site	Northridge	California
United States	Research Site	Ocoee	Florida
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Olean	New York
United States	Research Site	Orlando	Florida
United States	Research Site	Pahrump	Nevada
United States	Research Site	Pasadena	California
United States	Research Site	Peoria	Illinois
United States	Research Site	Petoskey	Michigan
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Plantation	Florida
United States	Research Site	Pleasantville	New Jersey
United States	Research Site	Portland	Oregon
United States	Research Site	Reading	Pennsylvania
United States	Research Site	Redondo Beach	California
United States	Research Site	Reno	Nevada
United States	Research Site	Richmond Heights	Missouri
United States	Research Site	Riverside	California
United States	Research Site	Rolla	Missouri
United States	Research Site	Sacramento	California
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	Santa Ana	California
United States	Research Site	Santa Monica	California
United States	Research Site	Searcy	Arkansas
United States	Research Site	Sierra Vista	Arizona
United States	Research Site	Slidell	Louisiana
United States	Research Site	Spring Valley	California
United States	Research Site	Staten Island	New York
United States	Research Site	Sterling	Illinois
United States	Research Site	Topeka	Kansas
United States	Research Site	Tucson	Arizona
United States	Research Site	Tustin	California
United States	Research Site	Virginia Beach	Virginia
United States	Research Site	W. Palm Beach	Florida
United States	Research Site	Walnut Creek	California
United States	Research Site	Warminster	Pennsylvania
United States	Research Site	Washington	District of Columbia
United States	Research Site	Waterloo	Iowa
United States	Research Site	West Chester	Pennsylvania
United States	Research Site	West Hills	California
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Witchita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Finland,  Mexico,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events
Primary	Laboratory variables
Primary	Physical examination
Primary	Cardiac evaluation
Primary	Hypoglycemic events
Primary	Electrocardiogram
Primary	Vital signs (blood pressure and pulse)
Primary	Body weight
Secondary	Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
Secondary	Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
Secondary	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
Secondary	C-reactive protein (CRP)
Secondary	Central obesity (waist circumference, hip circumference, waist/hip ratio)
Secondary	Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)