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

NCT00226330 | Terminated Phase 3

• 1 other identifier: D6160C00048
• Study Type: interventional
• Target: 1,100
• Locations: 7 countries
• Sites: 171

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 6.

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 (6)

• 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

Tesaglitazar DRUG

(0.5 or 1 mg)

Also known as: Galida

Pioglitazone DRUG

(15, 30 or 45 mg)

Also known as: Actos

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 6

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 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (171)

Research Site

Birmingham, Alabama, United States

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Columbiana, Alabama, United States

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Mobile, Alabama, United States

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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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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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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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Newark, Delaware, United States

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Washington D.C., District of Columbia, United States

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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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West Palm Beach, Florida, United States

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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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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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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Waterloo, Iowa, United States

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Topeka, Kansas, United States

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Witchita, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Slidell, Louisiana, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Haverhill, Massachusetts, United States

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Petoskey, Michigan, United States

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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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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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Pleasantville, New Jersey, United States

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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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Asheville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Lakewood, 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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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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Columbia, South Carolina, United States

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Memphis, Tennessee, United States

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Carrollton, Texas, United States

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Dallas, Texas, United States

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North Richland Hills, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Virginia Beach, Virginia, United States

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Gig Harbor, Washington, United States

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Huntington, West Virginia, United States

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Morón, Buenos Aires, Argentina

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Quilmes, Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Córdoba - Córdoba, Argentina

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Rosario, Argentina

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Salta - Salta, Argentina

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Curitiba, Brazil

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Fortaleza, Brazil

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Goiânia, Brazil

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Porto Alegre, Brazil

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Ribeirão Preto, Brazil

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São Paulo, Brazil

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Edmonton, Alberta, Canada

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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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St. John's, Newfoundland and Labrador, Canada

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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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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 Village, Ontario, Canada

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St. Catharines, Ontario, Canada

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Toronto, Ontario, Canada

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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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Helsinki, Finland

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Jakobstad, Finland

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Kauniainen, Finland

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Kuopio, Finland

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Pori, Finland

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Tampere, Finland

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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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Torreón, Mexico

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Zapopan, Mexico

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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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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

tesaglitazar; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Galida Medical Science Director, MD

  AstraZeneca

  STUDY DIRECTOR

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: September 23, 2005
• First Posted: September 27, 2005
• Study Start: March 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: November 19, 2010

Record last verified: 2010-11

Locations

ME (6); BR (6); US (110); AR (6); GB (15); FI (6); CA (22)