GALLANT 4 Tesaglitazar vs. Glibenclamide

NCT ID: NCT00255541

Last Updated: 2008-03-17

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

580 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-12-31

Brief Summary

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This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (glibenclamide) 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 double blind treatment period and a 3-week follow-up period. Tesaglitazar and glibenclamide will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.

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

Glibenclamide

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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Research Site

Antwerp, , Belgium

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Braine-l'Alleud, , Belgium

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Hasselt, , Belgium

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Liège, , Belgium

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Merksem, , Belgium

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Sint-Gillis-Waas, , Belgium

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Steenokkerzeel, , Belgium

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Shatin, N.T., , Hong Kong

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Balatonfüred, , Hungary

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Budapest, , Hungary

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Kaposvár, , Hungary

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Kecskemét, , Hungary

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Székesfehérvár, , Hungary

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Arenzano, , Italy

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Chiavari (GE), , Italy

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Chieri, , Italy

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Gubbio (PG), , Italy

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Milan, , Italy

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Napoli, , Italy

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Padua, , Italy

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Perugia, , Italy

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Piacenza, , 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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Udine, , Italy

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Kubang Kerian, Kota Bharu, Malaysia

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Kuala Lampur, , Malaysia

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México, D.F., Mexico

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Guadalajara, Jalisco, Mexico

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Zapopan, Jalisco, Mexico

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Veracruz, , Mexico

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Ås, , Norway

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Bergen, , Norway

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Kongsvinger, , Norway

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Lysaker, , Norway

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Oslo, , Norway

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Skedsmokorset, , Norway

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Sørumstand, , Norway

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Trondheim, , Norway

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Manila, , Philippines

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Pasig, , Philippines

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Krakow, , Poland

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Lublin, , Poland

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P³ock, , Poland

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Toruñ, , Poland

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Tychy, , Poland

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Warsaw, , Poland

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£ód?, , Poland

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Bratislava, , Slovakia

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Ilava, , Slovakia

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Košice, , Slovakia

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Kysucké Nové Mesto, , Slovakia

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Lučenec, , Slovakia

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Ľubochňa, , Slovakia

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Nitra, , Slovakia

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Prešov, , Slovakia

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Trnava, , Slovakia

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Cape Town, , South Africa

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Durban, , South Africa

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Houghton Gauteng, , South Africa

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Changhua, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Bangkok, , Thailand

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Countries

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Belgium Hong Kong Hungary Italy Malaysia Mexico Norway Philippines Poland Slovakia South Africa Taiwan Thailand

Other Identifiers

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D6160C00028

Identifier Type: -

Identifier Source: org_study_id

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