GALLANT 5 Tesaglitazar Versus Metformin

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Tesaglitazar, Metformin and matching placebos (Drug)

Phase: Phase 3

Status: No longer recruiting

Sponsored by: AstraZeneca

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

This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (metformin) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week placebo single blind run in period followed by a 52-week a double blind treatment period and a 3-week follow-up period. Tesaglitazar and metformin will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.

Official title: A 52-Wk Randomised, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin) Study to Evaluate the Efficacy, Safety & Tolerability of Tesaglitazar Therapy When Administered to Patients With Type 2 Diabetes

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

Primary outcome: Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)

Secondary outcome:

The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide

Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model

Lipid parameters (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids, lipoprotein particle size and co

C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio

FPG, homeostasis assessment model, insulin, proinsulin, C-peptide

Tumor necrosis factor-alpha, intracellular adhesion molecule-1

Fibrinogen

Urinary albumin excretion

Waist/hip ratio

Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values

Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C

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. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Provision of a written informed consent

- Men or women who are ³18 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 twice the normal range

- Creatine kinase above 3 times the upper limit of normal

- 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, Birmingham, Alabama, United States

Research Site, Columbiana, Alabama, United States

Research Site, Mobile, Alabama, United States

Research Site, San Vicente de Raspeig, Alicante, Spain

Research Site, Carlisle, Arizona, United States

Research Center, Sherwood, Arizona, United States

Research Site, Chula Vista, California, United States

Research Site, Escondido, California, United States

Research Site, Huntington Beach, California, United States

Research Site, Los Angeles, California, United States

Research Site, Mission Viejo, California, United States

Research Site, Orange, California, United States

Research Site, Pasadena, California, United States

Research Site, Pomona, California, United States

Research Site, Redondo Beach, California, United States

Research Site, Sacramento, California, United States

Research Site, Colorado Springs, Colorado, United States

Research Site, Wheat Ridge, Colorado, United States

Research Site, Clearwater, Florida, United States

Research Site, Gainesville, Florida, United States

Research Site, Hollywood, Florida, United States

Research Site, Jacksonville, Florida, United States

Research Site, Miami, Florida, United States

Research Site, West Palm Beach, Florida, United States

Research Site, Atlanta, Georgia, United States

Research Site, Brunswick, Georgia, United States

Research Site, Carollton, Georgia, United States

Research Site, Salo, Finland

Research Site, Tampere, Finland

Research Site, Vantaa, Finland

Research Site, Aschaffenburg, Germany

Research Site, Bad Segeberg, Germany

Research Site, Nijverdal, Netherlands

Research Site, Rijswijk, Netherlands

Research Site, Roelofarendsveen, Netherlands

Research Site, Rotterdam, Netherlands

Research Site, Bergen, Norway

Research Site, Rishon-Lezion, Israel

Research Site, Tel Aviv, Israel

Research Site, Zefat, Israel

Research Site, Beek en Donk, Netherlands

Research Site, Holon, Israel

Research Site, Jerusalem, Israel

Research Sites, Northampton, United Kingdom

Research Site, Wiltshire, United Kingdom

Research Site, Pirna, Germany

Research Site, Rotenburg/Fulda, Germany

Research Site, Ashkelon, Israel

Research Site, Haifa, Israel

Research Site, Coventry, United Kingdom

Research Site, Dundee, United Kingdom

Research Site, Glasgow, United Kingdom

Research Site, Manchester, United Kingdom

Research Site, Beckum, Germany

Research Site, Berlin, Germany

Research Site, Essen, Germany

Research Site, Feldafing, Germany

Research Site, Hamburg, Germany

Research Site, Hannover, Germany

Research Site, Hermaringen, Germany

Research Site, Aberdeen, United Kingdom

Research Site, Ayr, United Kingdom

Research Site, Bath, United Kingdom

Research Site, Berks, United Kingdom

Research Site, Bucks, United Kingdom

Research Site, Mikkeli, Finland

Research Site, Hämeenlinna, Finland

Research Site, Joensuu, Finland

Research Site, Helsinki, Finland

Research Site, Kouvola, Finland

Research Site, Oulu, Finland

Research Site, Kuopio, Finland

Research Site, Dresden, Germany

Research Site, Ehrenberg, Germany

Research Site, Begonte (Lugo), Spain

Research Site, Madrid, Spain

Research Site, Sevilla, Spain

Research Site, Oslo, Norway

Research Site, Østerås, Norway

Research Site, Alzira (Valencia), Spain

Research Site, Barcelona, Spain

Research Site, Bennebroe, Netherlands

Research Site, Den Haag, Netherlands

Research Site, Deurne, Netherlands

Research Site, Huizen, Netherlands

Research Site, Losser, Netherlands

Research Site, Künzing, Germany

Research Site, Langen, Germany

Research Site, Mannheim, Germany

Research Site, Marl, Germany

Research Site, Nürnberg, Germany

Research Site, Honolulu, Hawaii, United States

Research Site, Boise, Idaho, United States

Research Site, Evansville, Indiana, United States

Research Site, Kansas City, Kansas, United States

Research Site, Overland Park, Kansas, United States

Research Site, Witchita, Kansas, United States

Research Site, Bossier City, Louisiana, United States

Research Site, New Orleans, Louisiana, United States

Research Site, Baltimore, Maryland, United States

Research Site, Kalamazoo, Missouri, United States

Research Site, Las Vegas, Nevada, United States

Research Site, Hamilton, New Jersey, United States

Research Site, Albuquerque, New Mexico, United States

Research Site, Albany, New York, United States

Research Site, Bronx, New York, United States

Research Site, New York, New York, United States

Research Site, Pahrump, New York, United States

Research Site, Rochester, New York, United States

Research Site, White Plains, New York, United States

Research Site, Charlotte, North Carolina, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Dayton, Ohio, United States

Research Site, Kettering, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Medford, Oregon, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Simpsonville, South Carolina, United States

Research Site, Morristown, Tennessee, United States

Research Site, Corpus Christi, Texas, United States

Research Site, Dallas, Texas, United States

Research Site, Lubbock, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Villar del Arzobispo, Valencia, Spain

Research Site, Burke, Virginia, United States

Research Site, Norfolk, Virginia, United States

Research Site, Richmond, Virginia, United States

Research Site, Tacoma, Washington, United States

Research Site, Menomonee Falls, Wisconsin, United States

Research Site, Milwaukee, Wisconsin, United States

Starting date: August 2004
Last updated: July 27, 2006