GALLANT 8 Tesaglitazar Add-on to Metformin

NCT ID: NCT00251953

Last Updated: 2009-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

555 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-03-31

Brief Summary

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This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to metformin in patients with type 2 diabetes, not adequately controlled on optimized metformin treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-week double blind treatment period and a 3-week follow-up period

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tesaglitazar

Intervention Type DRUG

Metformin

Intervention Type DRUG

Eligibility Criteria

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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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Galida Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Adelaide, , Australia

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Brisbane, , Australia

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Cairns, , Australia

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Geelong, , Australia

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Melbourne, , Australia

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Perth, , Australia

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Sydney, , Australia

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Coquitlam, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Etobicoke, Ontario, Canada

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Hamilton, Ontario, Canada

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Hastings, Ontario, Canada

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Kingston, Ontario, Canada

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North York, Ontario, Canada

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Ottawa, Ontario, Canada

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Smith Falls, Ontario, Canada

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Toronto, Ontario, Canada

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Chomedey-Laval, Quebec, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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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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Berlin, , Germany

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Essen, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Mannheim, , Germany

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Nürberg, , Germany

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Rotenburg/Fulda, , Germany

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Bangalore, , India

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Hyderabad, , India

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New Delhi, , India

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Arenzano, , Italy

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Chiavari (GE), , Italy

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Chieri, , Italy

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Desio, , Italy

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Florence, , Italy

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Gubbio, , Italy

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Marsala, , Italy

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Messina, , Italy

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Milan, , Italy

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Monteccio Emilia, , Italy

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Napoli, , Italy

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Padua, , Italy

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Perugia, , Italy

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Pescara, , Italy

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Piacenza, , Italy

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Pistoia, , Italy

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Reggio Calabria, , Italy

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Reggio Emilia, , Italy

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Rho, , Italy

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Roma, , Italy

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Scandiano, , Italy

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Udine, , Italy

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Kubang Kerian, Kota Bharu, Malaysia

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Kuala Lumpur, , Malaysia

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Cebu City, , Philippines

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Quezon City, , Philippines

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Singapore, , Singapore

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Ängelholm, , Sweden

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Borås, , Sweden

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Dalby, , Sweden

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Gothenburg, , Sweden

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Höganäs, , Sweden

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Kungsör, , Sweden

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Malmo, , Sweden

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Mölndal, , Sweden

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Oskarshamn, , Sweden

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Skene, , Sweden

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Skrivarp, , Sweden

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Stenungsund, , Sweden

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Uppsala, , Sweden

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Aberdeen, , United Kingdom

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Aldershot, , United Kingdom

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Atherstone, , United Kingdom

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Barry, , United Kingdom

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Bath, , United Kingdom

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Bexhill-on-Sea, , United Kingdom

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Birmingham, , United Kingdom

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Bolton, , United Kingdom

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Cardiff, , United Kingdom

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Chippenham, , United Kingdom

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Coventry, , United Kingdom

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Dundee, , United Kingdom

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Edinburgh, , United Kingdom

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Glasgow, , United Kingdom

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Harrow, , United Kingdom

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Hastings, , United Kingdom

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Leeds, , United Kingdom

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Liverpool, , United Kingdom

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Manchester, , United Kingdom

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Plymouth, , United Kingdom

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Radstock, , United Kingdom

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Slough, , United Kingdom

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Swindon, , United Kingdom

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West Midlands, , United Kingdom

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Wrexham, , United Kingdom

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Countries

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Australia Canada Finland Germany India Italy Malaysia Philippines Singapore Sweden United Kingdom

Other Identifiers

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EudraCT No 2004-000348-25

Identifier Type: -

Identifier Source: secondary_id

D6160C00031

Identifier Type: -

Identifier Source: org_study_id

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