Study Stopped
The development program has been terminated
GALLEX 9: Safety and Tolerability of Oral Tesaglitazar When Added to Insulin Therapy in Patients With Type 2 Diabetes
An Open-Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar 0.5mg When Added to Insulin Therapy in Patients With Type 2 Diabetes Mellitus (GALLEX 9)
1 other identifier
interventional
270
1 country
69
Brief Summary
This is a 140-week open-label, multi-center long-term extension study from GALLANT 9 to monitor the safety and tolerability of oral tesaglitazar 0.5 mg and insulin in patients with type 2 diabetes during up to 140 weeks of treatment. The total duration, including treatment and follow-up, is 143 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Feb 2005
Typical duration for phase_3 diabetes-mellitus-type-2
69 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
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 28, 2005
CompletedFirst Posted
Study publicly available on registry
September 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedNovember 19, 2010
November 1, 2010
1.8 years
September 28, 2005
November 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Adverse events
Laboratory variables
Physical examination
Cardiac evaluation
Hypoglycemic events
Electrocardiogram
Vital signs (blood pressure and pulse)
Body weight
Secondary Outcomes (5)
Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C
C-reactive protein (CRP)
Central obesity (waist circumference, hip circumference, waist/hip ratio)
Interventions
0.5 in combination with insulin (with or without other oral antidiabetic drugs)
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.
- Completed the last two visits of the randomized treatment period in GALLANT 9
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, or neutropenia (low white blood cells)
- Creatinine levels of above twice the normal range
- Creatine kinase of above 3 times the upper limit of normal
- Previous enrollment in this long-term extension study
- 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 (69)
Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Fresno, California, United States
Research Site
Greenbrae, California, United States
Research Site
La Jolla, California, United States
Research Site
Northridge, California, United States
Research Site
Riverside, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Monica, California, United States
Research Site
Spring Valley, California, United States
Research Site
Walnut Creek, California, United States
Research Site
West Hills, California, United States
Research Site
Waterbury, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Gainesville, Florida, United States
Research Site
Hollywood, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Palm Harbor, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Augusta, Georgia, United States
Research Site
Dunwoody, Georgia, United States
Research Site
Boise, Idaho, United States
Research Site
Chicago, Illinois, United States
Research Site
Chicago Heights, Illinois, United States
Research Site
Gurnee, Illinois, United States
Research Site
Springfield, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Wichita, Kansas, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Baltimore, Maryland, United States
Research Site
Cadillac, Michigan, United States
Research Site
Richmond Heights, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Omaha, Nebraska, United States
Research Site
North Las Vegas, Nevada, United States
Research Site
Pahrump, Nevada, United States
Research Site
Dover, New Hampshire, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Brooklyn, New York, United States
Research Site
New Hyde Park, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Kettering, Ohio, United States
Research Site
Toledo, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Medford, Oregon, United States
Research Site
Portland, Oregon, United States
Research Site
Altoona, Pennsylvania, United States
Research Site
Cheswick, Pennsylvania, United States
Research Site
Erie, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Columbia, South Carolina, United States
Research Site
Greer, South Carolina, United States
Research Site
Corpus Christi, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Fort Worth, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Roseland, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Richmond, Virginia, United States
Research Site
Bellevue, Washington, United States
Research Site
Renton, Washington, United States
Research Site
Spokane, Washington, United States
Research Site
Tacoma, Washington, United States
Research Site
Madison, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Galida Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 28, 2005
First Posted
September 30, 2005
Study Start
February 1, 2005
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
November 19, 2010
Record last verified: 2010-11