GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

Condition(s) targeted: Type 2 Diabetes

Intervention: Tesaglitazar (Drug); Metformin (Drug); Fenofibrate (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Galida Medical Science DIrector, MD, Study Director, Affiliation: AstraZeneca

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)

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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: The change in HDL-C from baseline to the end of the randomized treatment period.

Secondary outcome:

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)

Central obesity (waist/hip ratio)

Pharmacokinetics of tesaglitazar

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Research Site, Curitiba, Brazil

Research Site, Sao Paulo, Brazil

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, SAINT JEAN DE LUZ, 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, TANTONVILLE, France

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, India, India

Research Site, Bangalore, India

Research Site, Delhi, India

Research Site, Penang, Malaysia

Research Site, Kuala Lumpur, 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, Johannesburg, South Africa

Research Site, Durban, 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, Changhua, Taiwan

Research Site, Taichung, Taiwan

Research Site, Taipei, Taiwan

Research Site, Calgary, Alberta, Canada

Research Site, Heidelberg, Baden-Württemberg, Germany

Research Site, Stuttgart, Baden-Württemberg, Germany

Research Site, München, Bayern, Germany

Research Site, Surrey, British Columbia, Canada

Research Site, Fortaleza, CE, Brazil

Research Site, Jakarta, DKI Jakarta, Indonesia

Research Site, Malang, East Java, Indonesia

Research Site, Goiânia, GO, Brazil

Research Site, Frankfurt, Hessen, Germany

Research Site, Mumbai, Mashatra, India

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, Hannover, Niedersachsen, Germany

Research Site, Düsseldorf, Nordrhein-Westfalen, Germany

Research Site, Münster, Nordrhein-Westfalen, Germany

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, Porto Alegre, RS, Brazil

Research Site, Dresden, Sachsen, Germany

Research Site, Yong-Kang City, Tainan County, Taiwan

Starting date: March 2005
Ending date: February 2007
Last updated: March 14, 2008