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GALLANT 9 Tesaglitazar vs. Placebo in Combination With Insulin

NCT ID: NCT00242372

Last Updated: 2009-04-22

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

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

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 0.5

Intervention Type DRUG

Insulin at least 30 units/day

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 for less than 20 years and receiving at least 30 U insulin per day

Exclusion Criteria

* 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
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 Sciences Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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

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Countries

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United States

Other Identifiers

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D6160C00033

Identifier Type: -

Identifier Source: org_study_id

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