Study Stopped
The development program has been terminated
GALLANT 9 Tesaglitazar vs. Placebo in Combination With Insulin
A 24-Week Randomised, Double-Blind, 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 Insulin
1 other identifier
interventional
370
1 country
71
Brief Summary
This is a 24-week randomized, double-blind, multi-center, placebo-controlled study of tesaglitazar in patients with type 2 diabetes who are not adequately controlled on insulin (along or in combination with one or more oral antidiabetic agents in addition to diet and lifestyle advice). The study comprises a 3-week enrollment period and a 24-week randomized, double blind, multi-center, placebo-controlled treatment period and a 3-week follow-up. Patients must receive at least 30 units of insulin per day and will continue their current oral antidiabetic treatment regimen throughout the study.
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-mellitus
Started Aug 2004
71 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
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 19, 2005
CompletedFirst Posted
Study publicly available on registry
October 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedApril 22, 2009
April 1, 2009
October 19, 2005
April 21, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary Outcomes (15)
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 from baseline to the end of the randomized treatment period
Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model from baseline to the end of the randomized treatment period
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
- +10 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 for less than 20 years and receiving at least 30 U insulin per day
You may not qualify if:
- Type 1 diabetes
- New York Heart Association heart failure Class III or IV
- Treatment with any thiazolidinedione class of antidiabetic agents
- 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 (71)
Research Site
Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Tuscson, Arizona, United States
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Fresno, California, United States
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Greenbrae, California, United States
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La Jolla, California, United States
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Northridge, California, United States
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Riverside, California, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Spring Valley, California, United States
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Walnut Creek, California, United States
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West Hills, California, United States
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Waterbury, Connecticut, United States
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Washington D.C., District of Columbia, 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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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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West Palm Beach, Florida, United States
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Augusta, Georgia, United States
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Dunwoody, Georgia, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Chicago Heights, Illinois, United States
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Gurnee, Illinois, United States
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Maywood, Illinois, United States
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Springfield, Illinois, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Cadillac, Michigan, United States
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Richmond Heights, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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North Las Vegas, Nevada, United States
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Pahrump, Nevada, United States
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Dover, New Hampshire, United States
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Roseland, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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New Hyde Park, New York, United States
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Charlotte, North Carolina, United States
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Wilmington, North Carolina, United States
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Cincinnati, Ohio, United States
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Kettering, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Altoona, Pennsylvania, United States
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Cheswick, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Columbia, South Carolina, United States
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Greer, South Carolina, United States
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Corpus Christie, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
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Renton, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Madison, Wisconsin, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Galida Medical Sciences 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
October 19, 2005
First Posted
October 20, 2005
Study Start
August 1, 2004
Study Completion
March 1, 2006
Last Updated
April 22, 2009
Record last verified: 2009-04