Study Stopped
The development program has been terminated
GALLANT 4 Tesaglitazar vs. Glibenclamide
A 52-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Administered to Patients With Type 2 Diabetes
1 other identifier
interventional
580
13 countries
66
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes
Started Sep 2004
Typical duration for phase_3 type-2-diabetes
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 17, 2005
CompletedFirst Posted
Study publicly available on registry
November 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedMarch 17, 2008
March 1, 2008
November 17, 2005
March 14, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary Outcomes (14)
Changes in the following variables from baseline to the end of the randomized treatment period:
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 c
C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
- +9 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (66)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Galida Medical Science Director, MD
AstraZeneca
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
November 17, 2005
First Posted
November 21, 2005
Study Start
September 1, 2004
Study Completion
December 1, 2006
Last Updated
March 17, 2008
Record last verified: 2008-03