Clinical trial NCT00261352: GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate
Official title: A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin or Metformin Combined With Fenofibrate) Study to Evaluate the Lipid Metabolic Effects, Safety and Tolerability of Tesaglitazar Therapy in Patients With Type 2 Diabetes and Low HDL-Cholesterol on a Fixed Background Therapy With a Statin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-12-05
Enrollment: 1000
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 24-week study to determine the lipid metabolic effects, safety, and tolerability of tesaglitazar compared with metformin and metformin in combination with fenofibrate in patients with type 2 diabetes and low high-density lipoprotein cholesterol (HDL-C). Improvement in dyslipidemia will be evaluated. The study comprises a 2-week enrollment period, 6-week run-in and a 24-week randomized, double blind, parallel group, multi-center, active controlled (metformin with or without fenofibrate) treatment period and a 3-week follow-up. From visit 2 (run-in), all patients will receive a standardized dose of statin (rosuvastatin)


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
* Diagnosed with type 2 diabetes
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

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 the normal range
* Received any investigational product in other clinical studies within 12 weeks
* 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

Primary outcomes:
measure: The change in HDL-C from baseline to the end of the randomized treatment period.
Secondary outcomes:
measure: Changes in the following variables from baseline to the end of the randomized treatment period:
measure: Lipid and lipoprotein variables (triglycerides [TG], non-HDL-C, total cholesterol, low-density lipoprotein cholesterol [LDL-C], lipoprotein particle size and concentration, free fatty acid, apolipoprotein [Apo] AI, Apo B, Apo CIII)
measure: Responder analyses for HDL-C, TG, and non-HDL-C according to pre-specified values
measure: The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C
measure: Risk markers for cardiovascular disease (C-reactive protein, insulin, homeostasis model assessment, LDL-C/HDL-C ratio, very-low-density lipoprotein cholesterol/LDL-C ratio, Apo B/Apo AI ratio)
measure: Central obesity (waist/hip ratio)
measure: Pharmacokinetics of tesaglitazar
measure: Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Research Site
state: CE
city: Goiânia
country: Brazil
facility: Research Site
state: GO
city: Porto Alegre
country: Brazil
facility: Research Site
state: RS
city: Curitiba
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Surrey
country: Canada
facility: Research Site
state: British Columbia
city: Bay Roberts
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Mount Pearl
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Bolton
country: Canada
facility: Research Site
state: Ontario
city: Brampton
country: Canada
facility: Research Site
state: Ontario
city: Etobicoke
country: Canada
facility: Research Site
state: Ontario
city: Hastings
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Kitchener
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Napanee
country: Canada
facility: Research Site
state: Ontario
city: Newboro
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Research Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Helsinki
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Lahti
country: Finland
facility: Research Site
city: Mikkeli
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Porvoo
country: Finland
facility: Research Site
city: Savonlinna
country: Finland
facility: Research Site
city: Seinäjoki
country: Finland
facility: Research Site
city: Suonenjoki
country: Finland
facility: Research Site
city: Tampere
country: Finland
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city: Turku
country: Finland
facility: Research Site
city: Vaasa
country: Finland
facility: Research Site
city: Aix En Provence
country: France
facility: Research Site
city: Ambriere Les Vallees
country: France
facility: Research Site
city: Beziers
country: France
facility: Research Site
city: Briey Cedex
country: France
facility: Research Site
city: Broglie
country: France
facility: Research Site
city: Chateau Gontier
country: France
facility: Research Site
city: Cremeaux
country: France
facility: Research Site
city: Falaise
country: France
facility: Research Site
city: Fontaine Saint Martin
country: France
facility: Research Site
city: Freyming Merlebach
country: France
facility: Research Site
city: GAN
country: France
facility: Research Site
city: Hyeres
country: France
facility: Research Site
city: Jarny
country: France
facility: Research Site
city: Jort
country: France
facility: Research Site
city: L'aigle
country: France
facility: Research Site
city: Lambersart
country: France
facility: Research Site
city: Le Lavandou
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Lomme Cedex
country: France
facility: Research Site
city: Marange Silvange
country: France
facility: Research Site
city: Marignane
country: France
facility: Research Site
city: Mars La Tour
country: France
facility: Research Site
city: Martigues
country: France
facility: Research Site
city: Mayenne
country: France
facility: Research Site
city: Metz
country: France
facility: Research Site
city: Mondelange
country: France
facility: Research Site
city: Montbrison
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Moutiers
country: France
facility: Research Site
city: Nantes Cedex 01
country: France
facility: Research Site
city: Nantes Cedex 1
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Poitiers
country: France
facility: Research Site
city: Roanne
country: France
facility: Research Site
city: Roquevaire
country: France
facility: Research Site
city: Rugles
country: France
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city: Saint Chamond
country: France
facility: Research Site
city: Saint Jean de Luz
country: France
facility: Research Site
city: Tantonville
country: France
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: Research Site
state: Baden-Württemberg
city: München
country: Germany
facility: Research Site
state: Bayern
city: Frankfurt
country: Germany
facility: Research Site
state: Hessen
city: Hannover
country: Germany
facility: Research Site
state: Niedersachsen
city: Düsseldorf
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Research Site
state: Sachsen
city: Aschaffenburg
country: Germany
facility: Research Site
city: Beckum
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Düsseldorf
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Gelnhausen
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Heilbronn
country: Germany
facility: Research Site
city: Künzing
country: Germany
facility: Research Site
city: Nürnberg
country: Germany
facility: Research Site
city: Pirna
country: Germany
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Shatin
country: Hong Kong
facility: Research Site
city: Balatonfüred
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Gy¿r
country: Hungary
facility: Research Site
city: Kaposvár
country: Hungary
facility: Research Site
city: Kecskemét
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Siófok
country: Hungary
facility: Research Site
city: Székesfehérvár
country: Hungary
facility: Research Site
city: Mumbai
country: India
facility: Research Site
state: Mashatra
city: Bangalore
country: India
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city: Delhi
country: India
facility: Research Site
city: India
country: India
facility: Research Site
city: Jakarta
country: Indonesia
facility: Research Site
state: DKI Jakarta
city: Malang
country: Indonesia
facility: Research Site
state: East Java
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Penang
country: Malaysia
facility: Research Site
city: Petaling Jaya
country: Malaysia
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Bodø
country: Norway
facility: Research Site
city: Elverum
country: Norway
facility: Research Site
city: Fredrikstad
country: Norway
facility: Research Site
city: Hamar
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Paradis
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Tvedestrand
country: Norway
facility: Research Site
city: Cebu City
country: Philippines
facility: Research Site
city: Makati City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Almada
country: Portugal
facility: Research Site
city: Amadora
country: Portugal
facility: Research Site
city: Caldas da Rainha
country: Portugal
facility: Research Site
city: Elvas
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Portalegre
country: Portugal
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: St.Petersburg
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Chur
country: Switzerland
facility: Research Site
city: Ilanz
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Monthey
country: Switzerland
facility: Research Site
city: Sion
country: Switzerland
facility: Research Site
city: Zürich
country: Switzerland
facility: Research Site
city: Yong-Kang City
country: Taiwan
facility: Research Site
state: Tainan County
city: Changhua
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Galida Medical Science DIrector, MD
role: STUDY_DIRECTOR
References: