GALLANT 5 Tesaglitazar Versus Metformin

NCT00214591 | Terminated Phase 3

• 1 other identifier: D6160C00029
• Study Type: interventional
• Target: 580
• Locations: 8 countries
• Sites: 130

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (13)

• 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

Interventions

GALIDA DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (130)

Research Site

Birmingham, Alabama, United States

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Columbiana, Alabama, United States

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Mobile, Alabama, United States

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Carlisle, Arizona, United States

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Sherwood, Arizona, United States

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Chula Vista, California, United States

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Escondido, California, United States

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Huntington Beach, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Orange, California, United States

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Pasadena, California, United States

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Pomona, California, United States

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Redondo Beach, California, United States

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Sacramento, California, United States

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Colorado Springs, Colorado, United States

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Wheat Ridge, Colorado, United States

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Clearwater, Florida, United States

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Gainesville, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Brunswick, Georgia, United States

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Carollton, Georgia, United States

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Honolulu, Hawaii, United States

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Boise, Idaho, United States

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Evansville, Indiana, United States

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Kansas City, Kansas, United States

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Overland Park, Kansas, United States

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Witchita, Kansas, United States

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Bossier City, Louisiana, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Kalamazoo, Missouri, United States

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Las Vegas, Nevada, United States

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Hamilton, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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New York, New York, United States

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Pahrump, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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White Plains, New York, United States

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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Kettering, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Simpsonville, South Carolina, United States

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Morristown, Tennessee, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Lubbock, Texas, United States

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San Antonio, Texas, United States

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Burke, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Menomonee Falls, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Hämeenlinna, Finland

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Helsinki, Finland

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Joensuu, Finland

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Kouvola, Finland

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Kuopio, Finland

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Mikkeli, Finland

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Oulu, Finland

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Salo, Finland

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Tampere, Finland

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Vantaa, Finland

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Aschaffenburg, Germany

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Bad Segeberg, Germany

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Beckum, Germany

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Berlin, Germany

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Dresden, Germany

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Ehrenberg, Germany

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Essen, Germany

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Feldafing, Germany

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Hamburg, Germany

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Hanover, Germany

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Hermaringen, Germany

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Künzing, Germany

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Langen, Germany

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Mannheim, Germany

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Marl, Germany

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Nuremberg, Germany

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Pirna, Germany

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Rotenburg/Fulda, Germany

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Ashkelon, Israel

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Haifa, Israel

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Holon, Israel

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Jerusalem, Israel

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Rishon LeZiyyon, Israel

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Safed, Israel

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Tel Aviv, Israel

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Beek en Donk, Netherlands

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Bennebroe, Netherlands

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Deurne, Netherlands

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Huizen, Netherlands

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Losser, Netherlands

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Nijverdal, Netherlands

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Rijswijk, Netherlands

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Roelofarendsveen, Netherlands

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Rotterdam, Netherlands

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The Hague, Netherlands

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Bergen, Norway

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Oslo, Norway

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Østerås, Norway

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San Vicente de Raspeig, Alicante, Spain

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Villar del Arzobispo, Valencia, Spain

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Alzira (Valencia), Spain

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Barcelona, Spain

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Begonte (Lugo), Spain

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Madrid, Spain

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Seville, Spain

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Aberdeen, United Kingdom

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Ayr, United Kingdom

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Bath, United Kingdom

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Berks, United Kingdom

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Bucks, United Kingdom

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Coventry, United Kingdom

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Dundee, United Kingdom

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Glasgow, United Kingdom

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Manchester, United Kingdom

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Northampton, United Kingdom

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Wiltshire, United Kingdom

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

tesaglitazar

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• AstraZeneca Galida Medical Science Director, MD

  AstraZeneca

  STUDY DIRECTOR

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: September 20, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: November 19, 2010

Record last verified: 2010-11

Locations

US (64); IL (7); FI (10); NL (10); DE (18); ES (7); NO (3); GB (11)