GALLANT 6 Tesaglitazar vs. Pioglitazone

NCT00214565 | Terminated Phase 3

• 1 other identifier: D6160C00030
• Study Type: interventional
• Target: 1,450
• Locations: 8 countries
• Sites: 74

Brief Summary

This is a 24-week randomized, double-blind, multi-center, active-controlled (pioglitazone) study of tesaglitazar (0.5 mg and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 3-week enrollment period, 6 week placebo single blind run in period followed by a 24-week double blind treatment period and a 3-week follow-up period.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)

Secondary Outcomes (9)

• The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide

• Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model

• Lipid parameters

• FPG, homeostasis assessment model, insulin, proinsulin, C-peptide

• Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values

Interventions

Galida DRUG

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 ³18 years of age
• Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
• Diagnosed with type 2 diabetes
• Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

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, 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (74)

Research Site

Altoona, Pennsylvania, United States

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Ciudad de Buenos Aires, Argentina

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Córdoba, Argentina

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Moron- Buenos Aires, Argentina

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Quilmes - Buenos Aires, Argentina

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Rosario, Argentina

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Salta, Argentina

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Curitiba, 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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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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Windsor, Ontario, Canada

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Trois-Rivières, Quebec, Canada

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Chicoutimi, Canada

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Longueuil, Canada

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Montreal, Canada

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St. John's, Canada

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Espoo, Finland

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Helsinki, Finland

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Kuopio, Finland

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Pietarsaar, Finland

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Pori, Finland

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Tampere, Finland

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Guadalajara Jalisco, Mexico

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Mexico City, Mexico

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México, Mexico

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Nuevo León, Mexico

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Puebla City, Mexico

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Torreón, Mexico

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Zapopan, Mexico

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Ås, Norway

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Bergen, Norway

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Elvernum, Norway

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Hamar, Norway

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Horten, Norway

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Kongsberg, Norway

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Lena, Norway

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Loeten, Norway

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Lysaker, Norway

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Oslo, Norway

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Osteraas, Norway

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Skedsmokorset, Norway

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Straume, Norway

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Tronheim, Norway

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Tønsberg, Norway

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Dublin, Ireland, United Kingdom

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Wexford, Ireland, United Kingdom

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Antrim, NI, United Kingdom

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Belfast, United Kingdom

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Cardiff, 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

Condition Hierarchy (Ancestors)

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

Study Officials

• AstraZeneca 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 20, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: November 19, 2010

Record last verified: 2010-11

Locations

AR (6); BR (1); CA (23); NO (15); FI (6); ME (7); US (1); GB (15)