Study Stopped
The development program has been terminated
GALLANT 7 Tesaglitazar Add-on to Sulphonylurea
A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Added to the Therapy of Patients With Type 2 Diabetes Poorly Controlled on Sulphonylurea Alone
2 other identifiers
interventional
555
10 countries
84
Brief Summary
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 sulphonylurea in patients with type 2 diabetes, not adequately controlled on optimized sulphonylurea 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
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 Jul 2004
84 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
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 9, 2005
CompletedFirst Posted
Study publicly available on registry
November 11, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedMarch 17, 2008
March 1, 2008
November 9, 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
- 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 (84)
Research Site
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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Tasmania, Australia
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Angers, France
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Hyères, France
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La Garde, France
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La Seyne-sur-Mer, France
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Laval, France
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Le Brusc, France
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Le Lavandou, France
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Montrevault, France
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Paris, France
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Saint-Cyr, France
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Six-Fours-les-Plages, France
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Tiercé, France
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Toulon, France
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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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Tel Litwinsky, Israel
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Bergen, Norway
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Elverum, Norway
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Enebakk, Norway
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Fredrikstad, Norway
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Gamle Fredrikstad, Norway
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Hamar, Norway
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Haugesund, Norway
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Hurdal, Norway
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Inderøy, Norway
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Lena, Norway
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Levanger, Norway
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Oslo, Norway
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Rud, Norway
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Sedsmokorset, Norway
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Soerumsand, Norway
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Stavanger, Norway
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Manila, Philippines
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Marikina City, Philippines
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Pasig, Philippines
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Cape Town, South Africa
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Chatsworth, South Africa
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Gauteng, South Africa
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Pretoria, South Africa
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Seoul, South Korea
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Suwon, South Korea
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Alzira (Valencia), Spain
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Barcelona, Spain
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Guissona (Lleida), Spain
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Madrid, Spain
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San Sebastian de Los Reyes ( Madrid), Spain
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San Vicente de Raspeig (Alicante), Spain
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Valencia, Spain
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Dublin, Ireland, United Kingdom
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Aberdeen, United Kingdom
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Barnsley, United Kingdom
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Bath, United Kingdom
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Belfast, United Kingdom
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Birmingham, United Kingdom
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Cardiff, United Kingdom
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Coventry, United Kingdom
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Dundee, United Kingdom
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East Sussex, United Kingdom
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Edinburgh, United Kingdom
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Glasgow, United Kingdom
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Leeds, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Shrewsbury, United Kingdom
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Surrey, United Kingdom
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West Midlands, United Kingdom
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Wiltshire, United Kingdom
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Wrexham, United Kingdom
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
MeSH Terms
Conditions
Condition 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 9, 2005
First Posted
November 11, 2005
Study Start
July 1, 2004
Study Completion
March 1, 2006
Last Updated
March 17, 2008
Record last verified: 2008-03