GALLEX 9: Safety and Tolerability of Oral Tesaglitazar When Added to Insulin Therapy in Patients With Type 2 Diabetes

November 18, 2010 updated by: AstraZeneca

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

270

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States
        • Research Site
      • Tucson, Arizona, United States
        • Research Site
    • California
      • 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
    • Connecticut
      • Waterbury, Connecticut, United States
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Research Site
    • Florida
      • 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
    • Georgia
      • Augusta, Georgia, United States
        • Research Site
      • Dunwoody, Georgia, United States
        • Research Site
    • Idaho
      • Boise, Idaho, United States
        • Research Site
    • Illinois
      • 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
    • Indiana
      • Indianapolis, Indiana, United States
        • Research Site
    • Kansas
      • Wichita, Kansas, United States
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • Michigan
      • Cadillac, Michigan, United States
        • Research Site
    • Missouri
      • Richmond Heights, Missouri, United States
        • Research Site
      • St. Louis, Missouri, United States
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Research Site
    • Nevada
      • North Las Vegas, Nevada, United States
        • Research Site
      • Pahrump, Nevada, United States
        • Research Site
    • New Hampshire
      • Dover, New Hampshire, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • Brooklyn, New York, United States
        • Research Site
      • New Hyde Park, New York, United States
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Research Site
      • Wilmington, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Kettering, Ohio, United States
        • Research Site
      • Toledo, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Medford, Oregon, United States
        • Research Site
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States
        • Research Site
      • Cheswick, Pennsylvania, United States
        • Research Site
      • Erie, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States
        • Research Site
      • Greer, South Carolina, United States
        • Research Site
    • Texas
      • 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
    • Virginia
      • Richmond, Virginia, United States
        • Research Site
    • Washington
      • Bellevue, Washington, United States
        • Research Site
      • Renton, Washington, United States
        • Research Site
      • Spokane, Washington, United States
        • Research Site
      • Tacoma, Washington, United States
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • Completed the last two visits of the randomized treatment period in GALLANT 9

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse events
Body weight
Physical examination
Electrocardiogram
Hypoglycemic events
Laboratory variables
Cardiac evaluation
Vital signs (blood pressure and pulse)

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 28, 2005

First Submitted That Met QC Criteria

September 28, 2005

First Posted (Estimate)

September 30, 2005

Study Record Updates

Last Update Posted (Estimate)

November 19, 2010

Last Update Submitted That Met QC Criteria

November 18, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6160C00049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Tesaglitazar

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe