Study Stopped
The development program has been terminated
GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate
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
2 other identifiers
interventional
1,000
18 countries
152
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started Mar 2005
152 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 1, 2005
CompletedFirst Posted
Study publicly available on registry
December 5, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedApril 22, 2009
April 1, 2009
December 1, 2005
April 21, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
The change in HDL-C from baseline to the end of the randomized treatment period.
Secondary Outcomes (8)
Changes in the following variables from baseline to the end of the randomized treatment period:
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)
Responder analyses for HDL-C, TG, and non-HDL-C according to pre-specified values
The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C
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)
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (152)
Research Site
Fortaleza, Ceará, Brazil
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Goiânia, Goiás, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Curitiba, Brazil
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Calgary, Alberta, Canada
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Surrey, British Columbia, Canada
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Bay Roberts, Newfoundland and Labrador, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Bolton, Ontario, Canada
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Brampton, Ontario, Canada
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Etobicoke, Ontario, Canada
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Hastings, Ontario, Canada
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Kingston, Ontario, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Napanee, Ontario, Canada
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Newboro, Ontario, Canada
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Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Helsinki, Finland
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Kuopio, Finland
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Lahti, Finland
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Mikkeli, Finland
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Oulu, Finland
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Porvoo, Finland
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Savonlinna, Finland
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Seinäjoki, Finland
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Suonenjoki, Finland
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Tampere, Finland
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Turku, Finland
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Vaasa, Finland
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Aix-en-Provence, France
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Ambriere LES Vallees, France
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Béziers, France
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Briey, France
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Broglie, France
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Château-Gontier, France
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Cremeaux, France
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Falaise, France
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Fontaine Saint Martin, France
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Freyming-Merlebach, France
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Gan, France
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Hyères, France
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Jarny, France
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Jort, France
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L'Aigle, France
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Lambersart, France
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Le Lavandou, France
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Lille, France
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Lomme, France
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Marange-Silvange, France
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Marignane, France
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Mars-la-Tour, France
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Martigues, France
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Mayenne, France
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Metz, France
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Mondelange, France
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Montbrison, France
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Montpellier, France
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Moûtiers, France
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Nantes, France
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Paris, France
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Poitiers, France
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Roanne, France
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Roquevaire, France
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Rugles, France
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Saint-Chamond, France
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Saint-Jean-de-Luz, France
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Tantonville, France
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Heidelberg, Baden-Wurttemberg, Germany
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Stuttgart, Baden-Wurttemberg, Germany
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München, Bavaria, Germany
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Frankfurt am Main, Hesse, Germany
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Hanover, Lower Saxony, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Münster, North Rhine-Westphalia, Germany
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Dresden, Saxony, Germany
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Berlin, State of Berlin, Germany
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Aschaffenburg, Germany
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Beckum, Germany
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Berlin, Germany
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Dresden, Germany
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Düsseldorf, Germany
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Essen, Germany
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Gelnhausen, Germany
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Hanover, Germany
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Heidelberg, Germany
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Heilbronn, Germany
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Künzing, Germany
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Nuremberg, Germany
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Pirna, Germany
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Hong Kong, Hong Kong
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Shatin, Hong Kong
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Balatonfüred, Hungary
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Budapest, Hungary
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Gy¿r, Hungary
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Kaposvár, Hungary
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Kecskemét, Hungary
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Miskolc, Hungary
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Siófok, Hungary
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Székesfehérvár, Hungary
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Mumbai, Mashatra, India
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Bangalore, India
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Delhi, India
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India, India
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Jakarta, DKI Jakarta, Indonesia
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Malang, East Java, Indonesia
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George Town, Malaysia
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Kuala Lumpur, Malaysia
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Petaling Jaya, Malaysia
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Bergen, Norway
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Bodø, Norway
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Elverum, Norway
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Fredrikstad, Norway
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Hamar, Norway
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Oslo, Norway
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Paradis, Norway
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Trondheim, Norway
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Tvedestrand, Norway
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Cebu City, Philippines
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Makati City, Philippines
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Manila, Philippines
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Almada, Portugal
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Amadora, Portugal
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Caldas da Rainha, Portugal
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Elvas, Portugal
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Lisbon, Portugal
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Portalegre, Portugal
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Moscow, Russia
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Saint Petersburg, Russia
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Yaroslavl, Russia
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Singapore, Singapore
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Cape Town, South Africa
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Durban, South Africa
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Johannesburg, South Africa
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Pretoria, South Africa
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Bern, Switzerland
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Chur, Switzerland
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Ilanz, Switzerland
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Lausanne, Switzerland
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Monthey, Switzerland
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Sion, Switzerland
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Zurich, Switzerland
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Yongkang District, Tainan County, Taiwan
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Changhua, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Galida Medical Science DIrector, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 1, 2005
First Posted
December 5, 2005
Study Start
March 1, 2005
Study Completion
December 1, 2006
Last Updated
April 22, 2009
Record last verified: 2009-04