GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate
Overview[ - collapse ][ - ]
| Purpose | 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) |
|---|---|
| Condition | Type 2 Diabetes |
| Intervention | Drug: Tesaglitazar Drug: Metformin Drug: Fenofibrate |
| Phase | Phase 3 |
| Sponsor | AstraZeneca |
| Responsible Party | AstraZeneca |
| ClinicalTrials.gov Identifier | NCT00261352 |
| First Received | December 1, 2005 |
| Last Updated | April 21, 2009 |
| Last verified | April 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 1, 2005 |
|---|---|
| Last Updated Date | April 21, 2009 |
| Start Date | March 2005 |
| Estimated Primary Completion Date | December 2006 |
| Current Primary Outcome Measures | The change in HDL-C from baseline to the end of the randomized treatment period. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
| 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) |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Type 2 Diabetes |
| Intervention | Drug: Tesaglitazar Drug: Metformin Drug: Fenofibrate |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 1000 |
| Estimated Completion Date | December 2006 |
| Estimated Primary Completion Date | Not Provided |
| 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Brazil, Canada, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Malaysia, Norway, Philippines, Portugal, Russian Federation, Singapore, South Africa, Switzerland, Taiwan |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00261352 |
|---|---|
| Other Study ID Numbers | D6160C00003 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | AstraZeneca |
| Study Sponsor | AstraZeneca |
| Collaborators | Not Provided |
| Investigators | Study Director: AstraZeneca Galida Medical Science DIrector, MD AstraZeneca |
| Verification Date | April 2009 |
Locations[ + expand ][ + ]
| Research Site | Fortaleza, CE, Brazil |
|---|---|
| Research Site | Goiânia, GO, Brazil |
| Research Site | Porto Alegre, RS, Brazil |
| Research Site | Curitiba, Brazil |
| Research Site | Sao Paulo, Brazil |
| Research Site | Calgary, Alberta, Canada |
| Research Site | Surrey, British Columbia, Canada |
| Research Site | Bay Roberts, Newfoundland and Labrador, Canada |
| Research Site | Mount Pearl, Newfoundland and Labrador, Canada |
| Research Site | St. John's, Newfoundland and Labrador, Canada |
| Research Site | Bolton, Ontario, Canada |
| Research Site | Brampton, Ontario, Canada |
| Research Site | Etobicoke, Ontario, Canada |
| Research Site | Hastings, Ontario, Canada |
| Research Site | Kingston, Ontario, Canada |
| Research Site | Kitchener, Ontario, Canada |
| Research Site | London, Ontario, Canada |
| Research Site | Mississauga, Ontario, Canada |
| Research Site | Napanee, Ontario, Canada |
| Research Site | Newboro, Ontario, Canada |
| Research Site | Ottawa, Ontario, Canada |
| Research Site | Montreal, Quebec, Canada |
| Research Site | Pointe-Claire, Quebec, Canada |
| Research Site | Sherbrooke, Quebec, Canada |
| Research Site | Helsinki, Finland |
| Research Site | Kuopio, Finland |
| Research Site | Lahti, Finland |
| Research Site | Mikkeli, Finland |
| Research Site | Oulu, Finland |
| Research Site | Porvoo, Finland |
| Research Site | Savonlinna, Finland |
| Research Site | Seinäjoki, Finland |
| Research Site | Suonenjoki, Finland |
| Research Site | Tampere, Finland |
| Research Site | Turku, Finland |
| Research Site | Vaasa, Finland |
| Research Site | Aix En Provence, France |
| Research Site | Ambriere Les Vallees, France |
| Research Site | Beziers, France |
| Research Site | Briey Cedex, France |
| Research Site | Broglie, France |
| Research Site | Chateau Gontier, France |
| Research Site | Cremeaux, France |
| Research Site | Falaise, France |
| Research Site | Fontaine Saint Martin, France |
| Research Site | Freyming Merlebach, France |
| Research Site | GAN, France |
| Research Site | Hyeres, France |
| Research Site | Jarny, France |
| Research Site | Jort, France |
| Research Site | L'aigle, France |
| Research Site | Lambersart, France |
| Research Site | Le Lavandou, France |
| Research Site | Lille, France |
| Research Site | Lomme Cedex, France |
| Research Site | Marange Silvange, France |
| Research Site | Marignane, France |
| Research Site | Mars La Tour, France |
| Research Site | Martigues, France |
| Research Site | Mayenne, France |
| Research Site | Metz, France |
| Research Site | Mondelange, France |
| Research Site | Montbrison, France |
| Research Site | Montpellier, France |
| Research Site | Moutiers, France |
| Research Site | Nantes Cedex 01, France |
| Research Site | Nantes Cedex 1, France |
| Research Site | Paris, France |
| Research Site | Poitiers, France |
| Research Site | Roanne, France |
| Research Site | Roquevaire, France |
| Research Site | Rugles, France |
| Research Site | Saint Chamond, France |
| Research Site | Saint Jean de Luz, France |
| Research Site | Tantonville, France |
| Research Site | Heidelberg, Baden-Württemberg, Germany |
| Research Site | Stuttgart, Baden-Württemberg, Germany |
| Research Site | München, Bayern, Germany |
| Research Site | Frankfurt, Hessen, Germany |
| Research Site | Hannover, Niedersachsen, Germany |
| Research Site | Düsseldorf, Nordrhein-Westfalen, Germany |
| Research Site | Münster, Nordrhein-Westfalen, Germany |
| Research Site | Dresden, Sachsen, Germany |
| Research Site | Aschaffenburg, Germany |
| Research Site | Beckum, Germany |
| Research Site | Berlin, Germany |
| Research Site | Dresden, Germany |
| Research Site | Düsseldorf, Germany |
| Research Site | Essen, Germany |
| Research Site | Gelnhausen, Germany |
| Research Site | Hannover, Germany |
| Research Site | Heidelberg, Germany |
| Research Site | Heilbronn, Germany |
| Research Site | Künzing, Germany |
| Research Site | Nürnberg, Germany |
| Research Site | Pirna, Germany |
| Research Site | Hong Kong, Hong Kong |
| Research Site | Shatin, Hong Kong |
| Research Site | Balatonfüred, Hungary |
| Research Site | Budapest, Hungary |
| Research Site | Gy¿r, Hungary |
| Research Site | Kaposvár, Hungary |
| Research Site | Kecskemét, Hungary |
| Research Site | Miskolc, Hungary |
| Research Site | Siófok, Hungary |
| Research Site | Székesfehérvár, Hungary |
| Research Site | Mumbai, Mashatra, India |
| Research Site | Bangalore, India |
| Research Site | Delhi, India |
| Research Site | India, India |
| Research Site | Jakarta, DKI Jakarta, Indonesia |
| Research Site | Malang, East Java, Indonesia |
| Research Site | Kuala Lumpur, Malaysia |
| Research Site | Penang, Malaysia |
| Research Site | Petaling Jaya, Malaysia |
| Research Site | Bergen, Norway |
| Research Site | Bodø, Norway |
| Research Site | Elverum, Norway |
| Research Site | Fredrikstad, Norway |
| Research Site | Hamar, Norway |
| Research Site | Oslo, Norway |
| Research Site | Paradis, Norway |
| Research Site | Trondheim, Norway |
| Research Site | Tvedestrand, Norway |
| Research Site | Cebu City, Philippines |
| Research Site | Makati City, Philippines |
| Research Site | Manila, Philippines |
| Research Site | Almada, Portugal |
| Research Site | Amadora, Portugal |
| Research Site | Caldas da Rainha, Portugal |
| Research Site | Elvas, Portugal |
| Research Site | Lisboa, Portugal |
| Research Site | Portalegre, Portugal |
| Research Site | Moscow, Russian Federation |
| Research Site | St.Petersburg, Russian Federation |
| Research Site | Yaroslavl, Russian Federation |
| Research Site | Singapore, Singapore |
| Research Site | Cape Town, South Africa |
| Research Site | Durban, South Africa |
| Research Site | Johannesburg, South Africa |
| Research Site | Pretoria, South Africa |
| Research Site | Bern, Switzerland |
| Research Site | Chur, Switzerland |
| Research Site | Ilanz, Switzerland |
| Research Site | Lausanne, Switzerland |
| Research Site | Monthey, Switzerland |
| Research Site | Sion, Switzerland |
| Research Site | Zürich, Switzerland |
| Research Site | Yong-Kang City, Tainan County, Taiwan |
| Research Site | Changhua, Taiwan |
| Research Site | Taichung, Taiwan |
| Research Site | Taipei, Taiwan |