Clinical trial NCT00214591: GALLANT 5 Tesaglitazar Versus Metformin
Official title: A 52-wk Randomised, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin) Study to Evaluate the Efficacy, Safety & Tolerability of Tesaglitazar Therapy When Administered to Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (metformin) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week placebo single blind run in period followed by a 52-week a double blind treatment period and a 3-week follow-up period. Tesaglitazar and metformin will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.


Eligibility criteria: Inclusion Criteria:

* 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

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, 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

Primary outcomes:
measure: Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary outcomes:
measure: The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
measure: Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
measure: Lipid parameters (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids, lipoprotein particle size and co
measure: C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
measure: FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
measure: Tumor necrosis factor-alpha, intracellular adhesion molecule-1
measure: Fibrinogen
measure: Urinary albumin excretion
measure: Waist/hip ratio
measure: Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
measure: Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
measure: Pharmacokinetics of tesaglitazar
measure: Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Columbiana
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Carlisle
country: United States
facility: Research Site
state: Arizona
city: Sherwood
country: United States
facility: Research Center
state: Arizona
city: Chula Vista
country: United States
facility: Research Site
state: California
city: Escondido
country: United States
facility: Research Site
state: California
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Mission Viejo
country: United States
facility: Research Site
state: California
city: Orange
country: United States
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state: California
city: Pasadena
country: United States
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state: California
city: Pomona
country: United States
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state: California
city: Redondo Beach
country: United States
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state: California
city: Sacramento
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state: California
city: Colorado Springs
country: United States
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state: Colorado
city: Wheat Ridge
country: United States
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state: Colorado
city: Clearwater
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state: Florida
city: Gainesville
country: United States
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state: Florida
city: Hollywood
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city: Jacksonville
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city: West Palm Beach
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city: Atlanta
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state: Georgia
city: Brunswick
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state: Georgia
city: Carollton
country: United States
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state: Georgia
city: Honolulu
country: United States
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state: Hawaii
city: Boise
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state: Idaho
city: Evansville
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state: Indiana
city: Kansas City
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city: Overland Park
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city: Witchita
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state: Kansas
city: Bossier City
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state: Louisiana
city: New Orleans
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city: Baltimore
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city: Kalamazoo
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state: Missouri
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city: Bronx
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city: New York
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city: Pahrump
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city: Rochester
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city: White Plains
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city: Charlotte
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state: North Carolina
city: Cincinnati
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city: Dayton
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city: Kettering
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city: Simpsonville
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city: Morristown
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city: Corpus Christi
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state: Texas
city: Dallas
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state: Texas
city: Lubbock
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city: San Antonio
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state: Texas
city: Burke
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state: Virginia
city: Norfolk
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state: Virginia
city: Richmond
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city: Tacoma
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city: Menomonee Falls
country: United States
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city: Milwaukee
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state: Wisconsin
city: Helsinki
country: Finland
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city: Hämeenlinna
country: Finland
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city: Joensuu
country: Finland
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city: Kouvola
country: Finland
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city: Kuopio
country: Finland
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city: Mikkeli
country: Finland
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city: Oulu
country: Finland
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city: Salo
country: Finland
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city: Tampere
country: Finland
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city: Vantaa
country: Finland
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Bad Segeberg
country: Germany
facility: Research Site
city: Beckum
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
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city: Ehrenberg
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Feldafing
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Hermaringen
country: Germany
facility: Research Site
city: Künzing
country: Germany
facility: Research Site
city: Langen
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Marl
country: Germany
facility: Research Site
city: Nürnberg
country: Germany
facility: Research Site
city: Pirna
country: Germany
facility: Research Site
city: Rotenburg/Fulda
country: Germany
facility: Research Site
city: Ashkelon
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Holon
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Rishon-Lezion
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Zefat
country: Israel
facility: Research Site
city: Beek en Donk
country: Netherlands
facility: Research Site
city: Bennebroe
country: Netherlands
facility: Research Site
city: Den Haag
country: Netherlands
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city: Deurne
country: Netherlands
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city: Huizen
country: Netherlands
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city: Losser
country: Netherlands
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city: Nijverdal
country: Netherlands
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city: Rijswijk
country: Netherlands
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city: Roelofarendsveen
country: Netherlands
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city: Rotterdam
country: Netherlands
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city: Bergen
country: Norway
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city: Oslo
country: Norway
facility: Research Site
city: Østerås
country: Norway
facility: Research Site
city: San Vicente de Raspeig
country: Spain
facility: Research Site
state: Alicante
city: Villar del Arzobispo
country: Spain
facility: Research Site
state: Valencia
city: Alzira (Valencia)
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Begonte (Lugo)
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Aberdeen
country: United Kingdom
facility: Research Site
city: Ayr
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Berks
country: United Kingdom
facility: Research Site
city: Bucks
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
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city: Dundee
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Northampton
country: United Kingdom
facility: Research Sites
city: Wiltshire
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Galida Medical Science Director, MD
role: STUDY_DIRECTOR
References: