GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00261352
• Other study ID #: D6160C00003
• Secondary ID: EudraCT No 2004-
• Status: Terminated
• Phase: Phase 3
• First received: December 1, 2005
• Last updated: April 21, 2009
• Start date: March 2005
• Est. completion date: December 2006

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1000
• Est. 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

• 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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Tesaglitazar

• Metformin

• Fenofibrate

Locations

Country	Name	City	State
Brazil	Research Site	Curitiba
Brazil	Research Site	Fortaleza	CE
Brazil	Research Site	Goiânia	GO
Brazil	Research Site	Porto Alegre	RS
Brazil	Research Site	Sao Paulo
Canada	Research Site	Bay Roberts	Newfoundland and Labrador
Canada	Research Site	Bolton	Ontario
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Calgary	Alberta
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	Montreal	Quebec
Canada	Research Site	Mount Pearl	Newfoundland and Labrador
Canada	Research Site	Napanee	Ontario
Canada	Research Site	Newboro	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Pointe-Claire	Quebec
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Surrey	British Columbia
Finland	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
France	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
Germany	Research Site	Aschaffenburg
Germany	Research Site	Beckum
Germany	Research Site	Berlin
Germany	Research Site	Dresden
Germany	Research Site	Dresden	Sachsen
Germany	Research Site	Düsseldorf	Nordrhein-Westfalen
Germany	Research Site	Düsseldorf
Germany	Research Site	Essen
Germany	Research Site	Frankfurt	Hessen
Germany	Research Site	Gelnhausen
Germany	Research Site	Hannover
Germany	Research Site	Hannover	Niedersachsen
Germany	Research Site	Heidelberg
Germany	Research Site	Heidelberg	Baden-Württemberg
Germany	Research Site	Heilbronn
Germany	Research Site	Künzing
Germany	Research Site	München	Bayern
Germany	Research Site	Münster	Nordrhein-Westfalen
Germany	Research Site	Nürnberg
Germany	Research Site	Pirna
Germany	Research Site	Stuttgart	Baden-Württemberg
Hong Kong	Research Site	Hong Kong
Hong Kong	Research Site	Shatin
Hungary	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
India	Research Site	Bangalore
India	Research Site	Delhi
India	Research Site	India
India	Research Site	Mumbai	Mashatra
Indonesia	Research Site	Jakarta	DKI Jakarta
Indonesia	Research Site	Malang	East Java
Malaysia	Research Site	Kuala Lumpur
Malaysia	Research Site	Penang
Malaysia	Research Site	Petaling Jaya
Norway	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
Philippines	Research Site	Cebu City
Philippines	Research Site	Makati City
Philippines	Research Site	Manila
Portugal	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
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	St.Petersburg
Russian Federation	Research Site	Yaroslavl
Singapore	Research Site	Singapore
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
South Africa	Research Site	Johannesburg
South Africa	Research Site	Pretoria
Switzerland	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
Taiwan	Research Site	Changhua
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taipei
Taiwan	Research Site	Yong-Kang City	Tainan County

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Brazil,  Canada,  Finland,  France,  Germany,  Hong Kong,  Hungary,  India,  Indonesia,  Malaysia,  Norway,  Philippines,  Portugal,  Russian Federation,  Singapore,  South Africa,  Switzerland,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in HDL-C from baseline to the end of the randomized treatment period.
Secondary	Changes in the following variables from baseline to the end of the randomized treatment period:
Secondary	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)
Secondary	Responder analyses for HDL-C, TG, and non-HDL-C according to pre-specified values
Secondary	The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C
Secondary	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)
Secondary	Central obesity (waist/hip ratio)
Secondary	Pharmacokinetics of tesaglitazar
Secondary	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