GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus

A Double-Blind, Multi-Centre, Active-Controlled (15, 30, and 45 mg Pioglitazone) Long-Term Extension Study to Evaluate the Safety and Tolerability of Tesaglitazar (0.5 and 1 mg) in Patients With Type 2 Diabetes Mellitus (GALLEX 6)

This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Tesaglitazar; Drug: Pioglitazone

• Study Type: Interventional
• Enrollment: 1100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad de Buenos Aires, Argentina
    • Research Site
  • Córdoba - Córdoba, Argentina
    • Research Site
  • Rosario, Argentina
    • Research Site
  • Salta - Salta, Argentina
    • Research Site
  • Buenos Aires
    • Moron, Buenos Aires, Argentina
      • Research Site
    • Quilmes, Buenos Aires, Argentina
      • Research Site
• Brazil
  • Curitiba, Brazil
    • Research Site
  • Fortaleza, Brazil
    • Research Site
  • Goiânia, Brazil
    • Research Site
  • Porto Alegre, Brazil
    • Research Site
  • Ribeirão Preto, Brazil
    • Research Site
  • São Paulo, Brazil
    • Research Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Research Site
  • British Columbia
    • Abbotsford, British Columbia, Canada
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    • Chilliwack, British Columbia, Canada
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    • Vancouver, British Columbia, Canada
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    • Victoria, British Columbia, Canada
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  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada
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  • Nova Scotia
    • Dartmouth, Nova Scotia, Canada
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    • Halifax, Nova Scotia, Canada
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    • Truro, Nova Scotia, Canada
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    • Windsor, Nova Scotia, Canada
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  • Ontario
    • Brampton, Ontario, Canada
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    • Etobicoke, Ontario, Canada
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    • Kingston, Ontario, Canada
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    • Niagara Falls, Ontario, Canada
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    • Oshawa, Ontario, Canada
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    • Scarborough, Ontario, Canada
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    • St. Catharines, Ontario, Canada
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    • Toronto, Ontario, Canada
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  • Quebec
    • Chicoutimi, Quebec, Canada
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    • Longueuil, Quebec, Canada
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    • Montreal, Quebec, Canada
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    • Trois-Rivières, Quebec, Canada
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• Finland
  • Helsinki, Finland
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  • Kauniainen, Finland
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  • Kuopio, Finland
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  • Pietarsaari, Finland
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  • Pori, Finland
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  • Tampere, Finland
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• Mexico
  • Guadalajara, Jalisco., Mexico
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  • México, D.F., Mexico
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  • Nuevo León, Monterrey, Mexico
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  • Puebla, Mexico, Mexico
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  • Torreon, Mexico
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  • Zapopan, Mexico
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• United Kingdom
  • Belfast, United Kingdom
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  • Cardiff, United Kingdom
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  • Co Antrim N Ireland, United Kingdom
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  • Co. Wexford, Ireland, United Kingdom
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  • Dublin, United Kingdom
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  • Edinburgh, United Kingdom
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  • Glasgow, United Kingdom
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  • Kent, United Kingdom
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  • Leeds, United Kingdom
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  • Mid Glamorgan, United Kingdom
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  • Pembrokeshire, United Kingdom
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  • Plymouth, United Kingdom
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  • Reading, United Kingdom
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  • Surrey, United Kingdom
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  • Wiltshire, United Kingdom
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• United States
  • Alabama
    • Birmingham, Alabama, United States
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    • Columbiana, Alabama, United States
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    • Mobile, Alabama, United States
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  • Arizona
    • Chandler, Arizona, United States
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    • Mesa, Arizona, United States
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    • Phoenix, Arizona, United States
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    • Sierra Vista, Arizona, United States
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    • Tucson, Arizona, United States
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  • Arkansas
    • Jonesboro, Arkansas, United States
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    • Little Rock, Arkansas, United States
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    • Searcy, Arkansas, United States
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  • California
    • Anaheim, California, United States
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    • Carmichael, California, United States
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    • Dinuba, California, United States
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    • Elk Grove, California, United States
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    • Encinitas, California, United States
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    • Encino, California, United States
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    • Fresno, California, United States
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    • Greenbrae, California, United States
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    • Loma Linda, California, United States
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    • Long Beach, California, United States
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    • Los Angeles, California, United States
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    • Mission Viejo, California, United States
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    • Northridge, California, United States
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    • Pasadena, California, United States
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    • Redondo Beach, California, United States
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    • Riverside, California, United States
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    • Sacramento, California, United States
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    • Santa Ana, 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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    • Tustin, 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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  • Delaware
    • Newark, Delaware, United States
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  • District of Columbia
    • Washington, District of Columbia, United States
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  • Florida
    • Brandon, Florida, United States
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    • Cooper City, Florida, United States
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    • Delray Beach, Florida, United States
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    • Gainesville, Florida, United States
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    • Hialeah, Florida, United States
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    • Hollywood, Florida, United States
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    • Jacksonville, Florida, United States
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    • Melbourne, Florida, United States
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    • Miami, Florida, United States
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    • Ocoee, Florida, United States
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    • Orlando, Florida, United States
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    • Plantation, Florida, United States
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    • W. Palm Beach, Florida, United States
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  • Georgia
    • Atlanta, Georgia, United States
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    • Augusta, Georgia, United States
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    • Columbus, Georgia, United States
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    • Dunwoody, Georgia, United States
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  • Illinois
    • Berwyn, Illinois, United States
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    • Chicago, Illinois, United States
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    • Elk Grove Village, Illinois, United States
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    • Gurnee, Illinois, United States
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    • Melrose Park, Illinois, United States
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    • North Chicago, Illinois, United States
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    • Peoria, Illinois, United States
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    • Sterling, Illinois, United States
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  • Indiana
    • Indianapolis, Indiana, United States
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  • Iowa
    • Des Moines, Iowa, United States
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    • Waterloo, Iowa, United States
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  • Kansas
    • Topeka, Kansas, United States
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    • Witchita, Kansas, United States
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  • Kentucky
    • Lexington, Kentucky, United States
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    • Louisville, Kentucky, United States
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  • Louisiana
    • New Orleans, Louisiana, United States
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    • Slidell, Louisiana, United States
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  • Maryland
    • Baltimore, Maryland, United States
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    • Columbia, Maryland, United States
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  • Massachusetts
    • Haverhill, Massachusetts, United States
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  • Michigan
    • Petoskey, Michigan, United States
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  • Missouri
    • Excelsior Springs, Missouri, United States
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    • Richmond Heights, Missouri, United States
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    • Rolla, Missouri, United States
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  • Nevada
    • Las Vegas, Nevada, United States
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    • North Las Vegas, Nevada, United States
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    • Pahrump, Nevada, United States
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    • Reno, Nevada, United States
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  • New Jersey
    • Pleasantville, New Jersey, United States
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  • New York
    • Manlius, New York, United States
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    • New York, New York, United States
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    • Olean, New York, United States
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    • Staten Island, New York, United States
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  • North Carolina
    • Asheville, North Carolina, United States
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    • Winston-Salem, North Carolina, United States
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  • Ohio
    • Cincinnati, Ohio, United States
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    • Lakewood, Ohio, United States
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  • Oklahoma
    • Oklahoma City, Oklahoma, United States
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  • Oregon
    • Medford, Oregon, United States
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    • Portland, Oregon, United States
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  • Pennsylvania
    • Altoona, Pennsylvania, United States
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    • Erie, Pennsylvania, United States
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    • Philadelphia, Pennsylvania, United States
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    • Reading, Pennsylvania, United States
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    • Warminster, Pennsylvania, United States
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    • West Chester, Pennsylvania, United States
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  • South Carolina
    • Columbia, South Carolina, United States
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  • Tennessee
    • Memphis, Tennessee, United States
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  • Texas
    • Carrollton, Texas, United States
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    • Dallas, Texas, United States
      • Research Site
    • North Richland Hills, Texas, United States
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    • San Antonio, Texas, United States
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  • Utah
    • Salt Lake City, Utah, United States
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  • Virginia
    • Norfolk, Virginia, United States
      • Research Site
    • Virginia Beach, Virginia, United States
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  • Washington
    • Gig Harbor, Washington, United States
      • Research Site
  • West Virginia
    • Huntington, West Virginia, United States
      • Research Site

Participation Criteria

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 6

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 by 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

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)
Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Galida Medical Science Director, MD, AstraZeneca

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: September 23, 2005
• First Submitted That Met QC Criteria: September 23, 2005
• First Posted (Estimate): September 27, 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: Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 6.
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Pioglitazone
• Other Study ID Numbers: D6160C00048